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NCT01318694 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Alisporivir Triple Therapy in Chronic Hepatitis C Genotype 1 Treatment-naïve Participants
A Phase 3 study, sponsored by Debiopharm International.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,081
- Enrollment target
NCT01318694: Completed Phase 3 study, sponsored by Debiopharm International.
NCT01318694 is a Phase 3 study that has completed, run by Debiopharm International. The registered enrollment target is 1,081 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01318694, a Phase 3 study, has completed, sponsored by Debiopharm International.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,081 participants
- Enrollment target
Study Summary
This study will assess the safety and efficacy of alisporivir (ALV; DEB025) triple therapy \[i.e., when added to peginterferon alfa-2a (PEG) and ribavirin (RBV)\] to optimize treatment in treatment-naïve participants with hepatitis C virus (HCV) genotype 1 (GT1)
Primary Outcome
SVR12 was defined as hepatitis C virus (HCV) RNA laboratory value below the level of quantification (\< LOQ; i.e., 25 IU/ml) 12 weeks after the end of treatment.
Interventions
- DRUG Ribavirin
- DRUG Peginterferon alfa-2a
- DRUG Alisporivir
- DRUG ALV Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,081 participants |
| Start Date | 2011-03 |
| Est. Completion | 2013-08 |
| Phase | Phase 3 |
What the finished NCT01318694 record still lists
NCT01318694 is an interventional study that assigns participants to a tested intervention. Its 1,081 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% higher).
The record links to 0 conditions, and to 4 interventions - of which Ribavirin is the first listed.
NCT01318694 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01318694 about?
NCT01318694 is a clinical study titled "Efficacy and Safety of Alisporivir Triple Therapy in Chronic Hepatitis C Genotype 1 Treatment-naïve Participants". This study will assess the safety and efficacy of alisporivir (ALV; DEB025) triple therapy \[i.e., when added to peginterferon alfa-2a (PEG) and ribavirin (RBV)\] to optimize treatment in treatment-naïve participants with hepatitis C virus (HCV) genotype 1 (GT1)
What is the current status of trial NCT01318694?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,081 participants. The study started on 2011-03. Estimated completion is 2013-08.
What interventions are being tested in trial NCT01318694?
The interventions under investigation include: Ribavirin (DRUG), Peginterferon alfa-2a (DRUG), Alisporivir (DRUG), ALV Placebo (DRUG).
Who is sponsoring clinical trial NCT01318694?
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 NCT01318694's enrollment target sits among peer trials
1,081 269th of 2000 higher than 1,732 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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