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NCT00874796 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety Study of GS-9450 Treatment for 6 Months in Patients With Chronic Hepatitis C Virus Infection
A Phase 2 study, sponsored by Gilead Sciences.
- Terminated
- Registry status
- Phase 2
- Development phase
- 307
- Enrollment target
NCT00874796 is a Phase 2 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 307 participants.
The verdict
NCT00874796, a Phase 2 study, was terminated before completion, sponsored by Gilead Sciences.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 307 participants
- Enrollment target
Study Summary
This is a Phase 2b, randomized, double-blind, parallel-group, placebo-controlled, multicenter study investigating the safety, tolerability and efficacy of two oral doses of GS-9450 in adults with chronic Hepatitis C Virus (HCV). Approximately 240 subjects 18-65 years of age who meet study entry criteria will be randomized (in other words, selected at random, like flipping a coin) to one of three treatment groups (80 subjects per treatment group) as follows:GS-9450 10 mg once daily,GS-9450 40 mg once daily, or matching placebo once daily. Following randomization, subjects will return within seven business days for a Baseline (Day 1) visit, at which time study medication will be dispensed and subjects will enter a 26 week treatment phase. During the treatment phase, subjects will receive study drug once daily for 24 weeks and then taper off of study drug over the following 2 weeks by receiving study drug once every other day for one week and then every 3 days for one week. Following completion of the treatment phase, subjects will enter a 4-week off-treatment follow-up phase.
Interventions
- DRUG Placebo
- DRUG GS-9450
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 307 participants |
| Start Date | 2009-05 |
| Est. Completion | 2010-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00874796
The ClinicalTrials.gov registry entry for NCT00874796 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 307 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00874796 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00874796 about?
NCT00874796 is a clinical study titled "Efficacy and Safety Study of GS-9450 Treatment for 6 Months in Patients With Chronic Hepatitis C Virus Infection". This is a Phase 2b, randomized, double-blind, parallel-group, placebo-controlled, multicenter study investigating the safety, tolerability and efficacy of two oral doses of GS-9450 in adults with chronic Hepatitis C Virus (HCV). Approximately 240 subjects 18-65 years of age who meet study entry crit...
What is the current status of trial NCT00874796?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 307 participants. The study started on 2009-05. Estimated completion is 2010-07.
What interventions are being tested in trial NCT00874796?
The interventions under investigation include: Placebo (DRUG), GS-9450 (DRUG).
Who is sponsoring clinical trial NCT00874796?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
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