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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) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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 III, Randomised, Double-blind and Placebo Controlled Study of Once Daily BI 201335, 240 mg for 12 or 24 Weeks in Combination With Pegylated interferon-a (PegIFNa) and Ribavirin (RBV) in Patients With Genotype 1 Chronic Hepatitis C Infection Who Failed a Prior PegIFN/RBV Treatment

NCT01358864•Boehringer Ingelheim

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Chronic hepatitis C genotype 1 infection, diagnosed at least 6 months prior to screening
•2. Confirmed prior virological failure with an approved dose of PegIFN/RBV
•3. Age 18 to 70 years,
•4. HCV RNA (RiboNucleic Acid) = 1,000 IU/mL at screening,

Exclusion Criteria

•1. HCV infection of mixed genotype; Hepatitis B Virus (HBV) or Human Immunodeficiency Virus (HIV) co-infection
•2. Evidence of acute or chronic liver disease due to causes other than chronic HCV infection,
•3. Decompensated liver disease, or history of decompensated liver disease,
•4. Body weight \< 40 or \> 125 kg,
•5. Clinical evidence of significant or unstable cardiovascular disease, chronic pulmonary disease, history or evidence of retinopathy or clinically significant ophthalmological disorder
•6. Pre-existing psychiatric condition that could interfere with the subject's participation in and completion of the study
•7. Laboratory parameters disorders (thalassemia major, sickle cell anemia or G6PD deficit)
•8. Hemoglobin \< 12 g/dL for women and \< 13 g/dL for men
•9. Patients who have been previously treated with at least one dose of any antiviral or immunomodulatory drug other than interferon alfa or ribavirin for acute or chronic HCV infection including and not restricted to protease or polymerase inhibitors,

Locations (116)

1220.7.0091 Boehringer Ingelheim Investigational Site

North Little Rock, Arkansas, United States

1220.7.0082 Boehringer Ingelheim Investigational Site

Englewood, Colorado, United States

1220.7.0095 Boehringer Ingelheim Investigational Site

Palm Harbor, Florida, United States

1220.7.0039 Boehringer Ingelheim Investigational Site

Columbus, Georgia, United States

1220.7.0013 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

1220.7.0062 Boehringer Ingelheim Investigational Site

Vaiparaiso, Indiana, United States

1220.7.0085 Boehringer Ingelheim Investigational Site

Baton Rouge, Louisiana, United States

1220.7.0087 Boehringer Ingelheim Investigational Site

Baton Rouge, Louisiana, United States

1220.7.0101 Boehringer Ingelheim Investigational Site

New Orleans, Louisiana, United States

1220.7.0027 Boehringer Ingelheim Investigational Site

Framingham, Massachusetts, United States

Key Dates

Start Date

June 1, 2011

Primary Completion Date

February 1, 2013

Completion Date

May 1, 2014

Last Updated

August 29, 2016

Enrollment

678

ACTUAL participants

Conditions

Hepatitis C, Chronic

Interventions

BI 201335

DRUG

Pegylated Interferon-alpha (IFN)

DRUG

Ribavirin (RBV)

DRUG

Placebo

DRUG

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Carcinoma, HepatocellularHepatitis C, Chronic+3 more

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COMPLETEDPHASE4

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 29, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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)

Inclusion Criteria

Exclusion Criteria

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study

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