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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 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 310 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01399619
The ClinicalTrials.gov registry entry for NCT01399619 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 310 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 3 interventions - of which BI201335 is the first listed.
NCT01399619 reports 0 study locations.
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.
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