Safety and Efficacy Study in Subjects With Chronic HCV and Underlying Hemophilia

Bristol-Myers Squibb71 enrolled

Overview

The primary objective for this study is to evaluate the proportion of subjects who achieve SVR12 (HCV RNA \< LLOQ (target not detected) at post-treatment follow-up Week 12 in subjects with Genotype(GT)-1b, -4 and GT-2, -3

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis C Virus

Interventions

Pegylated-Interferon-lambdaBIOLOGICAL

RibavirinDRUG

DaclatasvirDRUG

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: * Severe hemophilia (defined as \< 1% factor activity level) * Infection with the hepatitis C virus (HCV) with underlying hemophilia * Males 18 years of age and above * Have not been previously treated with an interferon Exclusion Criteria: * Not infected with the hepatitis B virus (HBV) or human immunodeficiency virus (HIV) * Chronic liver disease caused by any disease other than chronic HCV infection * Presence of Bethesda inhibitor * Current evidence of or history of portal hypertension

Locations (32)

Outcomes

Primary Outcomes

Percentage of Participants Who Achieved Sustained Virologic Response (SVR12) at Follow-Up Week 12

SVR12 was defined as HCV ribonucleic acid (RNA) less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12.

Time frame: Follow-up Week 12

Secondary Outcomes

Percentage of Participants With Rapid Virologic Response (RVR)

RVR was defined as HCV RNA less than the lower limit of quantitation, target not detected at Week 4.

Time frame: Treatment Week 4

Percentage of Participants With Complete Early Virologic Response (cEVR)

cEVR was defined as HCV RNA less than the lower limit of quantitation, target not detected at Week 12.

Time frame: Treatment Week 12

Percentage of Participants With End of the Treatment Response (EOTR)

EOTR was defined as HCV RNA less than the lower limit of quantitation, target not detected at end of treatment.

Time frame: End of the treatment (Week 12 for Cohort A, Week 24 for Cohort B)

Percentage of Participants With Sustained Virologic Response at Follow-Up Week 24 (SVR24)

SVR24 was defined as HCV RNA less than the lower limit of quantitation, target detected or target not detected at follow-up week 24.

Time frame: Follow-up Week 24

Percentage of Participants With Treatment-Emergent Cytopenic Abnormalities On-Treatment

Cytopenic abnormalities were defined as anemia: Hemoglobin (Hb) \<10 g/dL, and/or neutropenia: absolute neutrophils and bands (ANC) \<750 mm\^3, and/or thrombocytopenia: platelets \<50,000 mm\^3.

Time frame: After day 1 to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B)

Data from ClinicalTrials.gov

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Stanford Boswell Clinic

Palo Alto, California, United States

Rush University Medical Center

Chicago, Illinois, United States

Hospital Of The University Of Pennsylvania

Philadelphia, Pennsylvania, United States

Clinical Research Centers Of America

Murray, Utah, United States

Local Institution

Camperdown, New South Wales, Australia

Local Institution

Herston, Queensland, Australia

Local Institution

Adelaide, South Australia, Australia

Local Institution

Melbourne, Victoria, Australia

Local Institution

Herston, Australia

Local Institution

Grenoble, France

...and 22 more locations

Percentage of Participants With Flu-Like Symptoms and Musculoskeletal Symptoms On-Treatment

Flu-like symptoms were defined as pyrexia or chills or pain. Musculoskeletal symptoms were defined as arthralgia or myalgia or back pain.

Time frame: After day 1 to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B)

Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Dose Reductions, And Death

AE=any new untoward medical event or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Treatment-related SAE=possibly, probably, or certainly related to study drug.

Time frame: From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)

Number of Participants With Treatment Emergent Grade 3 to 4 Laboratory Abnormalities

Laboratory abnormalities were determined and graded using the Division of acquired immunodeficiency syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0. International Normalized Ratio (INR): \>2.0\*Upper limit of normal (ULN); Alanine aminotransferase (ALT) : \>5\*ULN; Aspartate aminotransferase (AST): \>5\*ULN; Prothrombin Time (PT): \>1.50\*ULN; Bilirubin (Total): \>2.5\*ULN; Triglycerides (fasting): \>750 mg/dL.

Time frame: After day 1 to to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B)