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NCT01728324 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Treatment of Patients With Hepatitis C Infection, Including Patients Who Are Not Eligible to Receive Peginterferon: HCVerso2
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 496
- Enrollment target
NCT01728324: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT01728324 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 496 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01728324, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 496 participants
- Enrollment target
Study Summary
The aim of the study is to confirm efficacy and safety of treatment with 600 mg of BID BI 207127 in combination with 120 mg QD FDV and RBV for 16 or 24 weeks in target chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.
Primary Outcome
Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus (HCV) RNA level \<25 IU/mL at 12 weeks after end of Treatment (EOT). SVR12, was assessed based on the observed HCV RNA result taken at least 10 weeks after treatment discontinuation. This definition was also applied to patients who discontinued treatment early: if the patient had HCV RNA undetected at least 10 weeks after stopping all treatment, they were considered a responder in the primary analysis. This
Interventions
- DRUG BI 207127-placebo: 8-week treatment
- DRUG Ribavirin: 24-week treatment
- DRUG BI 207127: 24-week treatment
- DRUG Faldaprevir: 24-week treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 496 participants |
| Start Date | 2012-11 |
| Est. Completion | 2015-01 |
| Phase | Phase 3 |
What the finished NCT01728324 record still lists
NCT01728324 is an interventional study that assigns participants to a tested intervention. The registered 496 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 (36% lower).
The record links to 0 conditions, and to 4 interventions - of which BI 207127-placebo: 8-week treatment is the first listed.
NCT01728324 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01728324 about?
NCT01728324 is a clinical study titled "Phase 3 Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Treatment of Patients With Hepatitis C Infection, Including Patients Who Are Not Eligible to Receive Peginterferon: HCVerso2". The aim of the study is to confirm efficacy and safety of treatment with 600 mg of BID BI 207127 in combination with 120 mg QD FDV and RBV for 16 or 24 weeks in target chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.
What is the current status of trial NCT01728324?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 496 participants. The study started on 2012-11. Estimated completion is 2015-01.
What interventions are being tested in trial NCT01728324?
The interventions under investigation include: BI 207127-placebo: 8-week treatment (DRUG), Ribavirin: 24-week treatment (DRUG), BI 207127: 24-week treatment (DRUG), Faldaprevir: 24-week treatment (DRUG).
Who is sponsoring clinical trial NCT01728324?
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 NCT01728324's enrollment target sits among peer trials
496 776th of 2000 higher than 1,223 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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