Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-27 @ 1:17 PM
Study NCT ID:
NCT00725803
Status:
COMPLETED
Last Update Posted:
2014-06-19
First Post:
2008-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Safety, Tolerability, Pharmacokinetics, and Activity of GS-9450 in Subjects With Chronic HCV
Sponsor:
Gilead Sciences
Organization:
Study Overview
Official Title:
A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Activity of GS-9450, a Caspase Inhibitor, in Subjects With Chronic Hepatitis C (GS-US-227-0102)
Status:
COMPLETED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to examine the safety, tolerability, pharmacokinetics (studies how the body processes a drug), and initial activity of GS-9450 in preventing liver damage due to scarring, or fibrosis, caused by Hepatitis C Virus (HCV) infection.
Detailed Description:
Approximately 32 subjects will receive GS 9450 or placebo for 14 consecutive days. Eight subjects will receive treatment within each of four dosing cohorts; 6 randomized to receive GS 9450 and two randomized to placebo:
Cohort 1: GS 9450 10 mg or placebo given daily x 14 days Cohort 2: GS 9450 40 mg or placebo given daily x 14 days Cohort 3: GS 9450 80 mg or placebo given daily x 14 days
If further characterization of the activity profile is deemed necessary, an additional cohort at a lower dose (5 mg) may be enrolled:
Cohort 4: GS 9450 5 mg or placebo given daily x 14 days
Each cohort will be conducted sequentially. Advancement to higher dose cohorts is dependent upon satisfactory safety and tolerability profiles of the preceding cohort as determined by Sponsor review (conducted in consultation with the Lead Investigator\[s\]). Progression to Cohort 4 (5 mg dose strength) will not require a safety review of Cohort 3 (80 mg dose strength); screening and randomization for Cohort 4 may begin immediately after fully enrolling Cohort 3. Alternatively, if a dose-response relationship is apparent in review of the blinded activity data from the first three cohorts, the final 5 mg cohort may be omitted.
Cohort 1: GS 9450 10 mg or placebo given daily x 14 days Cohort 2: GS 9450 40 mg or placebo given daily x 14 days Cohort 3: GS 9450 80 mg or placebo given daily x 14 days
If further characterization of the activity profile is deemed necessary, an additional cohort at a lower dose (5 mg) may be enrolled:
Cohort 4: GS 9450 5 mg or placebo given daily x 14 days
Each cohort will be conducted sequentially. Advancement to higher dose cohorts is dependent upon satisfactory safety and tolerability profiles of the preceding cohort as determined by Sponsor review (conducted in consultation with the Lead Investigator\[s\]). Progression to Cohort 4 (5 mg dose strength) will not require a safety review of Cohort 3 (80 mg dose strength); screening and randomization for Cohort 4 may begin immediately after fully enrolling Cohort 3. Alternatively, if a dose-response relationship is apparent in review of the blinded activity data from the first three cohorts, the final 5 mg cohort may be omitted.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: