Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01297270
The ClinicalTrials.gov registry entry for NCT01297270 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 658 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,884-participant average among 106 other Hepatitis C trials with a reported enrollment target (65% 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 3 interventions - of which Placebo is the first listed.
NCT01297270 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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.
-
SOF (Sovaldi®) +RBV for 16 or 24 Weeks and SOF+RBV+Peg-IFN for 12 Weeks in Adults With Genotype 2 or 3 Chronic HCV Infection
COMPLETED · Phase 3
-
Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir in Adults With Chronic HCV Infection Who Have Previously Received Treatment With Direct-Acting Antiviral Therapy
COMPLETED · Phase 3
-
Hepatitis C Antiviral Resistance in African-Americans
COMPLETED · Phase 3
-
Study Comparing Daclatasvir (BMS-790052) With Telaprevir Combined With Peginterferon Alfa-2a and Ribavirin in Patients With Chronic Hepatitis C Virus Infection
COMPLETED · Phase 3
-
An Efficacy, Safety and Tolerability Study of TMC435 in Genotype 1 Hepatitis C-infected Patients Who Relapsed After Previous Therapy
COMPLETED · Phase 3
-
Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir and Sofosbuvir/Velpatasvir in Adults With Chronic HCV Infection Who Have Not Previously Received Treatment With Direct-Acting Antiviral Therapy
COMPLETED · Phase 3
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.