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NCT01384383 · ClinicalTrials.gov registry record · Phase 2
GS-5885, GS-9451 With Peginterferon Alfa 2a (PEG) and Ribavirin in Treatment-Naïve Subjects With Chronic Genotype 1 Hep C Virus Infection and IL28B CC Genotype
A Phase 2 study, sponsored by Gilead Sciences.
- Terminated
- Registry status
- Phase 2
- Development phase
- 248
- Enrollment target
NCT01384383: Clinical Trial Phase 2 study, sponsored by Gilead Sciences.
NCT01384383 is a Phase 2 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 248 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01384383, a Phase 2 study, was terminated before completion, sponsored by Gilead Sciences.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 248 participants
- Enrollment target
Study Summary
This is a Phase 2, randomized, open-label exploratory study that will examine the antiviral efficacy, safety, and tolerability of Response guided treatment (RGT) with GS-5885 + GS-9451 + PEG/RBV (6 or 12 weeks), or Peginterferon Alfa 2a (PEG)/Ribavirin (RBV)alone (24 weeks) in treatment naïve subjects with chronic Hep C (HCV) infection with genotype (GT) 1 and IL28B CC genotype.
Primary Outcome
Sustained virologic response (SVR, defined as plasma HCV RNA \< lower limit of quantification \[LLoQ\] at 24 weeks after treatment cessation) following treatment with GS-5885 + GS-9451 + PEG/RBV for 6 or 12 weeks, or PEG/RBV for 24 weeks in IL28B CC subjects.
Interventions
- DRUG RBV
- DRUG PEG
- DRUG GS-5885
- DRUG GS-9451
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 248 participants |
| Start Date | 2011-08 |
| Est. Completion | 2013-06 |
| Phase | Phase 2 |
Why NCT01384383 stopped before completion
NCT01384383 is an interventional study that assigns participants to a tested intervention. The registered 248 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% higher).
The record links to 0 conditions, and to 4 interventions - of which RBV is the first listed.
NCT01384383 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01384383 about?
NCT01384383 is a clinical study titled "GS-5885, GS-9451 With Peginterferon Alfa 2a (PEG) and Ribavirin in Treatment-Naïve Subjects With Chronic Genotype 1 Hep C Virus Infection and IL28B CC Genotype". This is a Phase 2, randomized, open-label exploratory study that will examine the antiviral efficacy, safety, and tolerability of Response guided treatment (RGT) with GS-5885 + GS-9451 + PEG/RBV (6 or 12 weeks), or Peginterferon Alfa 2a (PEG)/Ribavirin (RBV)alone (24 weeks) in treatment naïve subjec...
What is the current status of trial NCT01384383?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 248 participants. The study started on 2011-08. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01384383?
The interventions under investigation include: RBV (DRUG), PEG (DRUG), GS-5885 (DRUG), GS-9451 (DRUG).
Who is sponsoring clinical trial NCT01384383?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01384383's enrollment target sits among peer trials
248 234th of 2000 higher than 1,767 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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