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NCT01439373 · ClinicalTrials.gov registry record · Phase 2
Safety, Antiviral Activity, and Pharmacokinetics of GSK2336805 With Peginterferon and Ribavirin in Chronic Hepatitis C Subjects
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
NCT01439373: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT01439373 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 16 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01439373, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
Study Summary
GSK2336805 is a hepatitis C virus (HCV) NS5A inhibitor being developed for the treatment of chronic hepatitis C (CHC). This study will assess the safety, antiviral activity, and pharmacokinetics of GSK2336805 alone and in combination with peginterferon alfa 2a and ribavirin in subjects with chronic hepatitis C (CHC).
Primary Outcome
RVR was defined as the proportion of participants below the assay lower limit of detection (LOD) \<18 International units per milliliter (IU/mL) for Hepatitis C virus (HCV) ribonucleic acid (RNA) after 4 weeks of treatment (Day 28). Participants achieving RVR at Day 28 were considered treatment responders. Participants with missing HCV RNA values at Day 28 or discontinued before Day 28 were considered as treatment failure . Proportion of participants with HCV genotype 1 achieving RVR was the pri
Interventions
- DRUG Ribavirin
- DRUG Pegylated interferon alfa-2a
- DRUG GSK2336805
- DRUG GSK2336805 Matching Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2011-07-07 |
| Est. Completion | 2011-12-05 |
| Phase | Phase 2 |
What the finished NCT01439373 record still lists
NCT01439373 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 4 interventions - of which Ribavirin is the first listed.
NCT01439373 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01439373 about?
NCT01439373 is a clinical study titled "Safety, Antiviral Activity, and Pharmacokinetics of GSK2336805 With Peginterferon and Ribavirin in Chronic Hepatitis C Subjects". GSK2336805 is a hepatitis C virus (HCV) NS5A inhibitor being developed for the treatment of chronic hepatitis C (CHC). This study will assess the safety, antiviral activity, and pharmacokinetics of GSK2336805 alone and in combination with peginterferon alfa 2a and ribavirin in subjects with chronic ...
What is the current status of trial NCT01439373?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2011-07-07. Estimated completion is 2011-12-05.
What interventions are being tested in trial NCT01439373?
The interventions under investigation include: Ribavirin (DRUG), Pegylated interferon alfa-2a (DRUG), GSK2336805 (DRUG), GSK2336805 Matching Placebo (DRUG).
Who is sponsoring clinical trial NCT01439373?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01439373's enrollment target sits among peer trials
16 1908th of 2000 higher than 82 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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