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NCT01399619 · ClinicalTrials.gov registry record · Phase 3
Phase III Trial of BI 201335 (Faldaprevir) in Treatment Naive (TN) and Relapser Hepatitis C Virus (HCV)-Human Immunodeficiency Virus (HIV) Coinfected Patients (STARTverso 4)
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 310
- Enrollment target
NCT01399619: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT01399619 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 310 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01399619, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 310 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 24-48 weeks, according to re-randomisation of Early Treatment Success (ETS) patients at 24 weeks to stop PegIFN/RBV or continue PegIFN/RBV until week 48. If no ETS, then PegIFN/RB for 48 weeks, in HCV treatment-naive or relapsers patients coinfected with HIV
Primary Outcome
Percentage of participants with sustained Virological Response SVR12: Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) level \<25 IU/mL, undetected 12 weeks after the planned end of treatment.
Interventions
- DRUG BI201335
- DRUG PegIFN/RBV
- DRUG BI201335 24W
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 310 participants |
| Start Date | 2011-09 |
| Est. Completion | 2014-06 |
| Phase | Phase 3 |
What the finished NCT01399619 record still lists
NCT01399619 is an interventional study that assigns participants to a tested intervention. The registered 310 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 (60% lower).
The record links to 0 conditions, and to 3 interventions - of which BI201335 is the first listed.
NCT01399619 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01399619 about?
NCT01399619 is a clinical study titled "Phase III Trial of BI 201335 (Faldaprevir) in Treatment Naive (TN) and Relapser Hepatitis C Virus (HCV)-Human Immunodeficiency Virus (HIV) Coinfected Patients (STARTverso 4)". 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 24-48 weeks, according to re-randomisation of Early Treatment Success (ETS) patients at 24 weeks to stop PegIFN/RBV or continue PegIFN/RBV until week 48. If...
What is the current status of trial NCT01399619?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 310 participants. The study started on 2011-09. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01399619?
The interventions under investigation include: BI201335 (DRUG), PegIFN/RBV (DRUG), BI201335 24W (DRUG).
Who is sponsoring clinical trial NCT01399619?
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 NCT01399619's enrollment target sits among peer trials
310 1107th of 2000 higher than 892 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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