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NCT01297270 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Genotype 1 Hepatitis C Infected Patients (STARTverso 2)
A Phase 3 study of Hepatitis C, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 658
- Enrollment target
- 20
- Study locations
NCT01297270: Completed Phase 3 study of Hepatitis C, sponsored by Boehringer Ingelheim.
NCT01297270 is a Phase 3 study of Hepatitis C that has completed, run by Boehringer Ingelheim. The registered enrollment target is 658 participants, below the 1,884-participant average among 106 other Hepatitis C trials with a reported enrollment target (65% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01297270, a Phase 3 study of Hepatitis C, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 658 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objective of this trial is to evaluate the efficacy and safety of two different treatment regimens with BI 201335, both in combination with PegIFN/RBV) as compared to standard of care (SOC) with PegIFN/RBV alone.
Primary Outcome
Percentage of participants with sustained virologic response 12 weeks post treatment (SVR12) defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level\<25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG BI201335
- DRUG PegIFN/RBV
Study Locations (20)
California
- 1220.47.0008 Boehringer Ingelheim Investigational Site - Bakersfield
- 1220.47.0019 Boehringer Ingelheim Investigational Site - Chula Vista
- 1220.47.0010 Boehringer Ingelheim Investigational Site - Coronado
- 1220.47.0033 Boehringer Ingelheim Investigational Site - La Jolla
- 1220.47.0035 Boehringer Ingelheim Investigational Site - La Mesa
- 1220.47.0011 Boehringer Ingelheim Investigational Site - Los Angeles
- 1220.47.0014 Boehringer Ingelheim Investigational Site - Los Angeles
- 1220.47.0100 Boehringer Ingelheim Investigational Site - Los Angeles
- 1220.47.0018 Boehringer Ingelheim Investigational Site - Oceanside
- 1220.47.0059 Boehringer Ingelheim Investigational Site - Poway
- 1220.47.0024 Boehringer Ingelheim Investigational Site - San Diego
- 1220.47.0037 Boehringer Ingelheim Investigational Site - San Diego
- 1220.47.0031 Boehringer Ingelheim Investigational Site - San Francisco
Alabama
- 1220.47.0004 Boehringer Ingelheim Investigational Site - Birmingham
- 1220.47.0045 Boehringer Ingelheim Investigational Site - Birmingham
- 1220.47.0050 Boehringer Ingelheim Investigational Site - Dothan
Arizona
- 1220.47.0061 Boehringer Ingelheim Investigational Site - Phoenix
Arkansas
- 1220.47.0091 Boehringer Ingelheim Investigational Site - North Little Rock
Colorado
- 1220.47.0082 Boehringer Ingelheim Investigational Site - Englewood
Connecticut
- 1220.47.0049 Boehringer Ingelheim Investigational Site - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 658 participants |
| Start Date | 2011-04 |
| Est. Completion | 2014-04 |
| Phase | Phase 3 |
What the finished NCT01297270 record still lists
NCT01297270 is an interventional study that assigns participants to a tested intervention. The registered 658 participants enrollment target is mid-sized for trials with a published cap, below the 1,884-participant average among 106 other Hepatitis C trials with a reported enrollment target (65% lower).
The record links to 1 condition, with Hepatitis C appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01297270 names 20 study sites across 6 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT01297270 about?
NCT01297270 is a clinical study titled "Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Genotype 1 Hepatitis C Infected Patients (STARTverso 2)". The objective of this trial is to evaluate the efficacy and safety of two different treatment regimens with BI 201335, both in combination with PegIFN/RBV) as compared to standard of care (SOC) with PegIFN/RBV alone.
What is the current status of trial NCT01297270?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 658 participants. The study started on 2011-04. Estimated completion is 2014-04.
What conditions does trial NCT01297270 study?
This clinical trial studies the following conditions: Hepatitis C.
What interventions are being tested in trial NCT01297270?
The interventions under investigation include: Placebo (DRUG), BI201335 (DRUG), PegIFN/RBV (DRUG).
Who is sponsoring clinical trial NCT01297270?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01297270 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hepatitis C
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01297270's enrollment target sits among peer trials
658 13th of 106 higher than 94 of 106 other Hepatitis C trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatitis C 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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