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NCT01215643 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Alisporivir Alone or Combined With RBV or PEG in Chronic Hepatitis C Genotype 2 and 3 Treatment-naïve Participants
A Phase 2 study, sponsored by Debiopharm International.
- Completed
- Registry status
- Phase 2
- Development phase
- 340
- Enrollment target
NCT01215643: Completed Phase 2 study, sponsored by Debiopharm International.
NCT01215643 is a Phase 2 study that has completed, run by Debiopharm International. The registered enrollment target is 340 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (156% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01215643, a Phase 2 study, has completed, sponsored by Debiopharm International.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 340 participants
- Enrollment target
Study Summary
The study is to investigate whether alisporivir (ALV; DEB025) alone or in combination with either ribavirin (RBV) or peginterferon alfa-2a (PEG) is more efficient compared to standard of care (PEG+RBV) in treatment-naïve participants with hepatitis C virus (HCV) genotype 2 and 3. In addition, triple therapy with DEB025 plus standard of care will be applied to participants not achieving rapid viral response (RVR) in the different arms.
Primary Outcome
RVR4LOQ was defined as RVR \[serum hepatitis C virus (HCV) ribonucleic acid (RNA) \< the limit of quantification (LOQ), i.e., \< 25 IU/mL\], after 4 weeks of treatment.
Interventions
- DRUG Ribavirin
- DRUG Peginterferon alfa-2a
- DRUG Alisporivir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 340 participants |
| Start Date | 2010-10 |
| Est. Completion | 2012-05 |
| Phase | Phase 2 |
What the finished NCT01215643 record still lists
NCT01215643 is an interventional study that assigns participants to a tested intervention. The registered 340 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 (156% higher).
The record links to 0 conditions, and to 3 interventions - of which Ribavirin is the first listed.
NCT01215643 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01215643 about?
NCT01215643 is a clinical study titled "Efficacy and Safety of Alisporivir Alone or Combined With RBV or PEG in Chronic Hepatitis C Genotype 2 and 3 Treatment-naïve Participants". The study is to investigate whether alisporivir (ALV; DEB025) alone or in combination with either ribavirin (RBV) or peginterferon alfa-2a (PEG) is more efficient compared to standard of care (PEG+RBV) in treatment-naïve participants with hepatitis C virus (HCV) genotype 2 and 3. In addition, triple...
What is the current status of trial NCT01215643?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 340 participants. The study started on 2010-10. Estimated completion is 2012-05.
What interventions are being tested in trial NCT01215643?
The interventions under investigation include: Ribavirin (DRUG), Peginterferon alfa-2a (DRUG), Alisporivir (DRUG).
Who is sponsoring clinical trial NCT01215643?
This trial is sponsored by Debiopharm International, which has 30 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01215643's enrollment target sits among peer trials
340 137th of 2000 higher than 1,861 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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