Administration of GV1001 for the Treatment of Progressive Supranuclear Palsy Who Completed Study GV1001-PSP-CL2-011

GemVax & Kael67 enrolled

Overview

The study will be conducted by the Sponsor to evaluate Twelve-months Long-Term Safety and Efficacy of GV1001 (1.12 mg) administered subcutaneously as a treatment for Progressive Supranuclear Palsy(PSP). In 75 patients diagnosed with PSP Richardson(PSP-RS) or PSP-Parkinsonism (PSP-P) who Completed Study GV1001-PSP-CL2-011.

In GV1001-PSP-CL2-011 study, subjects who were in the trial group (Study Group 1(GV1001 0.56 mg/day), Study Group 2(GV1001 1.12 mg/day) is alternately administered High-dose test drug(GV1001 1.12 mg/day) and placebo once a week from Ex-Visit 1(Visit 16, Week 26) to Ex-Visit 5(Visit 20, Week 30) and High-dose test drugs(GV1001 1.12 mg/day) are administered from Ex-Visit 6 (Visit 21, Week 32) to Ex-Visit 26(Visit 41, Week 72) every two weeks. In the GV1001-PSP-CL2-011 study, subjects who were in the placebo group are administered placebo at Ex-Visit 1 (Visit16, Week26), the first visit of the extension study, and Ex-Visit 2 (Visit17, Week27) to Ex-Visit 5 (Visit 20, Week 30), High-dose test drugs(GV1001 1.12 mg/day) are administered once a week and High-dose test drugs (GV1001 1.12 mg/day) are administered from Ex-Visit 6 (Visit 21, Week 32) to Ex-Visit 26(Visit 41, Week 72) every two weeks.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Progressive Supranuclear Palsy

Interventions

GV1001 PlaceboDRUG

0.9% normal saline

GV1001 1.12mgDRUG

Lyophilized peptide from hTERT

Eligibility

Sex: ALLMin age: 41 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * A person who has been registered in the GV1001-PSP-CL2-011 clinical trial and has completed administration by Week 24 * A patient who accompanied all visits with the subject for the scheduled visit of this clinical trial, has a guardian who can supervise the subject's compliance with the examination and examination procedures conducted at the time of the visit, and provides information on the subject's indications, and whose guardian has agreed in writing to participate in the clinical trial (except where it is unnecessary to accompany the guardian at the discretion of the investigator) * Patient and/or representative of the patient who has voluntarily agreed in writing to participate in this clinical trial Exclusion Criteria: * Patients deemed unsuitable by the investigator to participate in this extension study * Pregnant or male subjects who do not consent to contraception by medically approved methods (surgical infertility, intrauterine contraceptive devices, fallopian tube ligature, double blocking (combined use of male condoms, female condoms, cervical caps, contraceptive diaphragm and sponges) and 90 days after clinical trial participation However, women who have undergone menopause or surgical infertility procedures (such as vasectomy and difficult conception on both sides) before participating in clinical trials can participate without consent to contraception. * Pregnant women or breastfeeding women

Locations (5)

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Kyung Hee University Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Adverse Event

Time frame: 12 months

Change in Hematological tests WBC(10^3/µl)

WBC(10\^3/µl) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

Time frame: 12 months

Change in Hematological tests RBC(10^6/µl)

RBC(10\^6/µl) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

Time frame: 12 months

Change in Hematological tests Hemoglobin(g/dL)

Hemoglobin(g/dL) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

Time frame: 12 months

Change in Hematological tests Hematocrit(%)

Hematocrit(%) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

Data from ClinicalTrials.gov

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Seoul National University Hospital

Seoul, South Korea

Time frame: 12 months

Change in Hematological tests Platelets count(10^3/µl)

Platelets count(10\^3/µl) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

Time frame: 12 months

Change in Hematological tests WBC differential count (Neutrophils(%))

WBC differential count (Neutrophils(%) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

Time frame: 12 months

Change in Hematological tests WBC differential count( Lymphocytes(%))

Lymphocytes(%) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

Time frame: 12 months

Change in Hematological tests WBC differential count( Monocytes(%))

Monocytes(%) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

Time frame: 12 months

Change in Hematological tests WBC differential count(Eosinophils(%))

Eosinophils(%) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

Time frame: 12 months

Change in Hematological tests WBC differential count(Basophils(%))

Basophils(%) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

Time frame: 12 months

Change in Hematochemical tests BUN(mg/dL)

BUN(mg/dL) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

Time frame: 12 months

Change in Hematochemical tests Creatinine(mg/dL)

Creatinine(mg/dL) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

Time frame: 12 months

Change in Hematochemical tests Uric acid(mg/dL)

Uric acid(mg/dL) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

Time frame: 12 months

Change in Hematochemical tests Total bilirubin(mg/dL)

Total bilirubin(mg/dL) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

Time frame: 12 months

Change in Hematochemical tests Albumin(g/dL)

Albumin(g/dL) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

Time frame: 12 months

Change in Hematochemical tests Total Protein(g/dL)

Total Protein(g/dL) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

Time frame: 12 months

Change in Hematochemical tests ALT(U/L)

ALT(U/L) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

Time frame: 12 months

Change in Hematochemical tests AST(U/L)

AST(U/L) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

Time frame: 12 months

Change in Hematochemical tests γ-GTP(U/L)

γ-GTP(U/L) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

Time frame: 12 months

Change in Hematochemical tests Alkaline phosphatase(U/L)

Alkaline phosphatase(U/L) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

Time frame: 12 months

Change in Hematochemical tests Glucose(mg/dL)

Glucose(mg/dL) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

Time frame: 12 months

Change in Hematochemical tests Total Cholesterol(mg/dL)

Total Cholesterol(mg/dL) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

Time frame: 12 months

Change in urine tests Protein-Albumin(mg/dL)

Protein-Albumin(mg/dL) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

Time frame: 12 months

Change in urine tests Glucose(mg/dL)

Time frame: 12 months

Change in urine tests Ketones(mg/dL)

Ketones(mg/dL) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

Time frame: 12 months

Change in urine tests WBC(HPF)

WBC(HPF) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

Time frame: 12 months

Change in urine tests Blood-RBC(HPF)

Blood-RBC(HPF) For the laboratory test results, continuous variables will present the test values at each visit as well as descriptive statistics (number of subjects observed, mean, standard deviation, median, minimum, and maximum) for changes from the baseline(Ex-Visit 1(Visit 16, Week 26) by both integration and treatment group in the extension study. For categorical variables, shift tables will be presented by treatment group

Time frame: 12 months

Blood Pressure (mmHG)

Change in Blood Pressure (mmHG)

Time frame: 12 months

Pulse rate(beats per min)

Change in Pulse rate(beats per min)

Time frame: 12 months

Respiratory rate(breaths per min)

Change in Respiratory rate(breaths per min)

Time frame: 12 months

temperature(℃)

Change in temperature(℃)

Time frame: 12 months

EKG

EKG result(normal or abnormal)

Time frame: 12 months