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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 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 678 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01358864
The ClinicalTrials.gov registry entry for NCT01358864 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 678 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01358864 reports 0 study locations.
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.
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