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NCT01330316 · ClinicalTrials.gov registry record · Phase 3
A Rollover Study of BI 201335 in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-experienced Genotype 1 Hepatitis C Infected Patients
A Phase 3 study of Hepatitis C, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 119
- Enrollment target
- 20
- Study locations
NCT01330316 is a Phase 3 study of Hepatitis C that has completed, run by Boehringer Ingelheim. The registered enrollment target is 119 participants, below the 1,889-participant average among 106 other Hepatitis C trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 13 states.
The verdict
NCT01330316, a Phase 3 study of Hepatitis C, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 119 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objective of this trial is to collect evidence for the safety and efficacy of 24 weeks of treatment with BI 201335 240 mg in combination with 24 or 48 weeks of Pegylated Interferon (PegIFN) and ribavirin (RBV) in treatment experienced patients who have been withdrawn from PegIFN and RBV treatment due to lack of efficacy in the 1220.7, 1220.30 and 1220.47 trials.
Conditions Studied
Interventions
- DRUG PegIFN/RBV
- DRUG BI 201335
Study Locations (20)
Texas
- 1220.48.0063 Boehringer Ingelheim Investigational Site - Arlington
- 1220.48.0029 Boehringer Ingelheim Investigational Site - Austin
- 1220.48.0017 Boehringer Ingelheim Investigational Site - Dallas
- 1220.48.0071 Boehringer Ingelheim Investigational Site - Dallas
- 1220.48.0081 Boehringer Ingelheim Investigational Site - Forth Worth
California
- 1220.48.0011 Boehringer Ingelheim Investigational Site - Los Angeles
- 1220.48.0018 Boehringer Ingelheim Investigational Site - Oceanside
Florida
- 1220.48.0078 Boehringer Ingelheim Investigational Site - Fort Lauderdale
- 1220.48.0095 Boehringer Ingelheim Investigational Site - Palm Harbor
Massachusetts
- 1220.48.0027 Boehringer Ingelheim Investigational Site - Framingham
- 1220.48.0065 Boehringer Ingelheim Investigational Site - Springfield
Alabama
- 1220.48.0004 Boehringer Ingelheim Investigational Site - Birmingham
Arkansas
- 1220.48.0091 Boehringer Ingelheim Investigational Site - North Little Rock
Georgia
- 1220.48.0039 Boehringer Ingelheim Investigational Site - Columbus
Illinois
- 1220.48.0013 Boehringer Ingelheim Investigational Site - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2011-07 |
| Est. Completion | 2014-06 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01330316
The ClinicalTrials.gov registry entry for NCT01330316 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 119 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,889-participant average among 106 other Hepatitis C trials with a reported enrollment target (94% lower). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hepatitis C appearing as the primary indexed condition, and to 2 interventions - of which PegIFN/RBV is the first listed.
NCT01330316 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Texas, California, Florida.
Frequently Asked Questions
What is clinical trial NCT01330316 about?
NCT01330316 is a clinical study titled "A Rollover Study of BI 201335 in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-experienced Genotype 1 Hepatitis C Infected Patients". The objective of this trial is to collect evidence for the safety and efficacy of 24 weeks of treatment with BI 201335 240 mg in combination with 24 or 48 weeks of Pegylated Interferon (PegIFN) and ribavirin (RBV) in treatment experienced patients who have been withdrawn from PegIFN and RBV treatmen...
What is the current status of trial NCT01330316?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 119 participants. The study started on 2011-07. Estimated completion is 2014-06.
What conditions does trial NCT01330316 study?
This clinical trial studies the following conditions: Hepatitis C.
What interventions are being tested in trial NCT01330316?
The interventions under investigation include: PegIFN/RBV (DRUG), BI 201335 (DRUG).
Who is sponsoring clinical trial NCT01330316?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01330316 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
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