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NCT01358864 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-Experienced Genotype 1 Hepatitis C Infected Patients (STARTverso 3)
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 678
- Enrollment target
NCT01358864: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT01358864 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 678 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (12% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01358864, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 678 participants
- Enrollment target
Study Summary
The aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 48 weeks as compared to PegIFN/RBV alone in chronic GT-1 hepatitis C virus infected patients who failed a prior PegIFN/RBV treatment.
Primary Outcome
Percentage of participants with sustained virological response (SVR12) 12 weeks post treatment defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level \<25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.
Interventions
- DRUG Placebo
- DRUG Ribavirin (RBV)
- DRUG BI 201335
- DRUG Pegylated Interferon-alpha (IFN)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 678 participants |
| Start Date | 2011-06 |
| Est. Completion | 2014-05 |
| Phase | Phase 3 |
What the finished NCT01358864 record still lists
NCT01358864 is an interventional study that assigns participants to a tested intervention. The registered 678 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (12% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01358864 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01358864 about?
NCT01358864 is a clinical study titled "Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-Experienced Genotype 1 Hepatitis C Infected Patients (STARTverso 3)". The aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 48 weeks as compared to PegIFN/RBV alone in chronic GT-1 hepatitis C virus infected patients who failed a prior PegIFN/RBV treatment.
What is the current status of trial NCT01358864?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 678 participants. The study started on 2011-06. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01358864?
The interventions under investigation include: Placebo (DRUG), Ribavirin (RBV) (DRUG), BI 201335 (DRUG), Pegylated Interferon-alpha (IFN) (DRUG).
Who is sponsoring clinical trial NCT01358864?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01358864's enrollment target sits among peer trials
678 536th of 2000 higher than 1,464 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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