Randomized Double-Blind Efficacy and safety study of Autologous HB-adMSCs versus placebo for the treatment of Multiple Sclerosis. This study will be for 24 subjects with 6 infusions over a 52 week period. Study participants will continue their established concomitant medications during participation in this investigation.
Each eligible study subject will receive a total of 6 intravenous infusions of HB-adMSCs or placebo. Study infusions will be administered with the following regimen, Week 0, 4, 8, 16, 24, and 32. There will be one follow-up visit and end of study at week 52.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
Hope Biosciences Stem Cell Research Foundation
Sugar Land, Texas, United States
Change From Baseline in Physical Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument
The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. The developers used the SF-36 as a base and added 18 questions to address MS-specific problems, including fatigue and cognitive function. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function. There is no single overall score for MSQOL-54. Two summary scores - physical health and mental health - can be derived from a weighted combination of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life).
Time frame: Baseline to Week 52
Change From Baseline in Mental Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. The developers used the SF-36 as a base and added 18 questions to address MS-specific problems, including fatigue and cognitive function. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function. There is no single overall score for MSQOL-54. Two summary scores - physical health and mental health - can be derived from a weighted combination of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life).
Time frame: Baseline to Week 52
Change From Baseline in Cognitive Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Cognitive Function subscale. The score ranges from 0 to 100 percent, and is 15% of the total Mental Health Composite Score.
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Time frame: Baseline to Week 52
Change From Baseline in Emotional Well-Being Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Emotional Wellbeing sub-scale. The score ranges from 0 to 100 percent, and is 29% of the total Mental Health Composite Score.
Time frame: Baseline to Week 52
Change From Baseline in Health Distress Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Health Distress sub-scale. The score ranges from 0 to 100 percent, and is 14% of the total Mental Health Composite Score and 11% of the total Physical Health Composite Score.
Time frame: Baseline to Week 52
Change From Baseline in RL/Emotional Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Role Limitation/Emotional sub-scale. The score ranges from 0 to 100 percent, and is 24% of the total Mental Health Composite Score.
Time frame: Baseline to Week 52
Change From Baseline in Overall Quality of Life Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Overall Quality of Life sub-scale. The score ranges from 0 to 100 percent, and is 18% of the total Mental Health Composite Score.
Time frame: Baseline to Week 52
Change From Baseline in Energy/Fatigue Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Energy/Fatigue sub-scale. The score ranges from 0 to 100 percent, and is 12% of the total Physical Health Composite Score.
Time frame: Baseline to Week 52
Change From Baseline in Health Perception Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Health Perception sub-scale. The score ranges from 0 to 100 percent, and is 17% of the total Physical Health Composite Score.
Time frame: Baseline to Week 52
Change From Baseline in Physical Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Physical Function sub-scale. The score ranges from 0 to 100 percent, and is 17% of the total Physical Health Composite Score.
Time frame: Baseline to Week 52
Change From Baseline in RL/Physical Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Role Limitations - Physical sub-scale. The score ranges from 0 to 100 percent, and is 12% of the total Physical Health Composite Score.
Time frame: Baseline to Week 52
Change From Baseline in Pain Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Pain subscale. The score ranges from 0 to 100 percent, and is 11% of the total Physical Health Composite Score.
Time frame: Baseline to Week 52
Change From Baseline in Social Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Social Function subscale. The score ranges from 0 to 100 percent, and is 12% of the total Physical Health Composite Score.
Time frame: Baseline to Week 52
Change From Baseline in Sexual Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.
The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function, and each one is scored from 0 to 100. Two summary scores - physical health and mental health - can be derived from a weighted summation of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life). This outcome measure shows the change from baseline of the Sexual Function subscale. The score ranges from 0 to 100 percent, and is 8% of the total Physical Health Composite Score.
Time frame: Baseline to Week 52
Analysis of Covariance (ANCOVA) Model - Physical Health Composite Score Change From Baseline Multiple Sclerosis Quality of Life (MSQOL)-54
Analysis of covariance (ANCOVA) is a statistical model that combines linear regression and ANOVA to analyze the results of different treatments. In this outcome measure, ANCOVA was used to analyze change in the physical health composite score in treatment versus placebo. The ANCOVA model was used to compare HB-adMSC patients with placebo patients on Change from Baseline to Week 52 with a fixed factor of treatment, fixed stratification factors of MS severity, age and gender, and a covariate of the baseline value for the score on the corresponding outcome measure. This model allows us to test the significance of the effects of the treatment at Week 52. Total score for this subscale is 100, so the range of scores for the ANCOVA model (showing average change in scores) would be -100 to 100 (theoretically). Higher scores show better outcomes--in this model, a positive score would indicate improvement and a negative score indicates worsening. Subscales are interpreted separately.
Time frame: Baseline to Week 52
Analysis of Covariance (ANCOVA) Model - Mental Health Composite Score Change From Baseline Multiple Sclerosis Quality of Life (MSQOL)-54 Composite Score
Analysis of covariance (ANCOVA) is a statistical model that combines linear regression and ANOVA to analyze the results of different treatments. In this outcome measure, ANCOVA was used to analyze change in the mental health composite score in treatment versus placebo. The ANCOVA model was used to compare HB-adMSC patients with placebo patients on Change from Baseline to Week 52 with a fixed factor of treatment, fixed stratification factors of MS severity, age and gender, and a covariate of the baseline value for the score on the corresponding outcome measure. This model allows us to test the significance of the effects of the treatment at Week 52. Total score for this subscale is 100, so the range of scores for the ANCOVA model (showing average change in scores) would be -100 to 100 (theoretically). Higher scores show better outcomes--in this model, a positive score would indicate improvement and a negative score indicates worsening. Subscales are interpreted separately.
Time frame: Baseline to Week 52
Bayesian Statistical Analysis - Analysis of Covariance (ANCOVA) Model - Physical Health Composite Score Change From Baseline Multiple Sclerosis Quality of Life (MSQOL)-54
Bayesian analysis is a statistical method that uses probability distributions to make statistical inferences about parameters using prior information. In this outcome measure, Bayesian analysis was used to analyze change in the physical health composite score in treatment versus placebo. In this study, Bayesian analysis was used to estimate the posterior distribution and to estimate the probability of the true treatment difference of change from baseline to Week 52. A linear model for each visit was constructed to model within-subject observation covariance structures by multivariate normal (MVN) distribution in the Markov chain Monte Carlo (MCMC) procedure. Total score for this subscale is 100, so the range of scores for the ANCOVA model (showing average change in scores) would be -100 to 100 (theoretically). Higher scores show better outcomes--in this model, a positive score would indicate improvement and a negative score indicates worsening. Subscales are interpreted separately.
Time frame: Baseline to Week 52
Bayesian Statistical Analysis - Analysis of Covariance (ANCOVA) Model - Mental Health Composite Score Change From Baseline - Multiple Sclerosis Quality of Life (MSQOL)-54
Bayesian analysis is a statistical method that uses probability distributions to make statistical inferences about parameters using prior information. In this outcome measure, Bayesian analysis was used to analyze change in the mental health composite score in treatment versus placebo. In this study, Bayesian analysis was used to estimate the posterior distribution and to estimate the probability of the true treatment difference of change from baseline to Week 52. A linear model for each visit was constructed to model within-subject observation covariance structures by multivariate normal (MVN) distribution in the Markov chain Monte Carlo (MCMC) procedure. Total score for this subscale is 100, so the range of scores for the ANCOVA model (showing average change in scores) would be -100 to 100 (theoretically). Higher scores show better outcomes--in this model, a positive score would indicate improvement and a negative score indicates worsening. Subscales are interpreted separately.
Time frame: Baseline to Week 52
Analysis of Covariance (ANCOVA) Model - Total Expanded Disability Status Scale (EDSS) Scores Through Week 52 - Change From Baseline - Efficacy Analysis Set
The EDSS is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. This scale ranges from 0 to 10 in 0.5-unit increments and a higher score represents increased disability. Scoring is based on an examination by a neurologist.
Time frame: Baseline to Week 52
Analysis of Covariance (ANCOVA) Model - Change From Baseline Barthel Index Scores Through Week 52 - Efficacy Analysis Set
The Barthel index is an ordinal scale that evaluates functional independence in the domains of personal care and mobility. A total of ten variables describing activities of daily living and mobility are considered, with a higher number reflecting better capacity to operate independently. The Barthel Index assesses the level of help needed by a person on a set of ten activities of daily living (ADL) related to mobility and self-care. Score ranges from 0 points to 20 points, with lower scores indicating increased disability.
Time frame: Baseline to Week 52
ANCOVA Model - Change From Baseline 9-Hole Peg Test Scores - Dominant Hand Avg Time Through Week 52
The 9-HPT is a short, standardized upper extremity exam. It measures the time taken to complete the test activity, recorded in seconds. The higher the score the worse the disability.
Time frame: Baseline to Week 52
Analysis of Covariance (ANCOVA) Model - Change From Baseline 9-Hole Peg Test Scores - Non-Dominant Hand Avg Time Through Week 52
The 9-HPT is a short, standardized upper extremity exam. It measures the time taken to complete the test activity, recorded in seconds. The higher the score the worse the disability.
Time frame: Baseline to Week 52
Analysis of Covariance (ANCOVA) Model - Change in Patient Health Questionnaire (PHQ-9) Test Scores
The PHQ-9 is the most used depression and suicidal thoughts screening test used to monitor the severity of depression and response to treatment. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
Time frame: Baseline to Week 52
Baseline Vitals Values - Height
Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
Time frame: Baseline
Change From Baseline Vitals Values - Weight
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
Time frame: Baseline to Week 52
Change From Baseline Vitals Values - Body Mass Index
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
Time frame: Baseline to Week 52
Change From Baseline Vitals Values - Respiratory Rate
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
Time frame: Baseline to Week 52
Change From Baseline Vitals Values - Temperature
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
Time frame: Baseline to Week 52
Change From Baseline Vitals Values - Systolic Blood Pressure
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
Time frame: Baseline to Week 52
Change From Baseline Vitals Values - Diastolic Blood Pressure
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
Time frame: Baseline to Week 52
Change From Baseline Vitals Values - Pulse Rate
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
Time frame: Baseline to Week 52
Change From Baseline Vitals Values - Oxygen Saturation
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
Time frame: Baseline to Week 52
Change From Baseline Physical Examination Results - Abdomen
Change From Baseline Physical Examination Results by Treatment Week - Descriptive Statistics - Safety Analysis Set
Time frame: Baseline to Week 52
Change From Baseline Physical Examination Results - Cardiovascular
Change From Baseline Physical Examination by Treatment Week - Descriptive Statistics - Safety Analysis Set
Time frame: Baseline to Week 52
Change From Baseline Physical Examination Results - HEENT
Change From Baseline Physical Examination by Treatment Week - Descriptive Statistics - Safety Analysis Set
Time frame: Baseline to Week 52
Change From Baseline Physical Examination Results - Lymph Node
Change From Baseline Physical Examination by Treatment Week - Descriptive Statistics - Safety Analysis Set
Time frame: Baseline to Week 52
Change From Baseline Physical Examination Results - Musculoskeletal
Change From Baseline Physical Examination by Treatment Week - Descriptive Statistics - Safety Analysis Set
Time frame: Baseline to Week 52
Change From Baseline Physical Examination Results - Neurological
Change From Baseline Physical Examination by Treatment Week - Descriptive Statistics - Safety Analysis Set
Time frame: Baseline to Week 52
Change From Baseline Physical Examination Results - Respiratory
Change From Baseline Physical Examination by Treatment Week - Descriptive Statistics - Safety Analysis Set
Time frame: Baseline to Week 52
Change From Baseline Physical Examination Results - Skin
Change From Baseline Physical Examination by Treatment Week - Descriptive Statistics - Safety Analysis Set
Time frame: Baseline to Week 52
Laboratory Values - CBC (x10^3 Cells/uL)
Unit (x10\^3 cells/uL) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set
Time frame: Baseline to Week 52
Laboratory Values - CBC (% of WBC)
Changes from baseline in CBC laboratory values with unit of % of white blood cell count.
Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)
Laboratory Values - CBC (% of Total Blood Cell Count)
Changes from baseline in CBC laboratory values with unit of % of total blood cell count.
Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)
Laboratory Values - CBC (g/dL)
Changes from baseline in CBC laboratory values with unit of g/dL
Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)
Laboratory Values - CBC (pg)
Changes from baseline in CBC laboratory values with unit of pg
Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)
Laboratory Values - CBC (fL)
Changes from baseline in CBC laboratory values with unit of fL.
Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)
Laboratory Values - CBC (x10^6 Cells/uL)
Changes from baseline in CBC laboratory values with unit of x10\^6 cells/uL.
Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)
Laboratory Values - CBC (RDW)
Changes from baseline in CBC laboratory values with unit of % (RDW - Red Cell Distribution Width)
Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)
Laboratory Values - CMP (g/dL)
Changes from baseline in CMP laboratory values with unit of g/dL.
Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)
Laboratory Values - CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL))
Changes from baseline in CMP laboratory values with units of Ratio: Albumin(g/dL) to Calc. Globulin(g/dL)
Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)
Laboratory Values - CMP (U/L)
Changes from baseline in CMP laboratory values with units of U/L.
Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)
Laboratory Values - CMP (mg/dL)
Changes from baseline in CMP laboratory values with units of mg/dL.
Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)
Laboratory Values - CMP (mEq/L)
Changes from baseline in CMP laboratory values with units of mEq/L.
Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)
Laboratory Values - CMP (mL/Min/1.73m^2)
Changes from baseline in CMP laboratory values with units of mL/min/1.73m\^2.
Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)
Laboratory Values - CMP (Ratio: Urea Nitrogen (mg/dL) to Creatinine (mg/dL))
Changes from baseline in CMP laboratory values with units of Ratio: Urea Nitrogen (mg/dL) to Creatinine (mg/dL).
Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)
Laboratory Values - Coagulation Panel (Seconds)
Changes from baseline in Coagulation Panel values with units of seconds.
Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)
Laboratory Values. Coagulation Panel (Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds))
Changes from baseline in Coagulation laboratory values with units of Ratio: Prothrombin time (seconds) / Mean normal prothrombin time (seconds).
Time frame: Baseline (Week 0), Week 24, and End of Study (Week 52)