Antiviral Effect and Safety of BI201335 +PegIFN/RBV in HCV-GT1 - Full Text View

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00774397

Purpose

The current Standard of Care (SOC) for chronic HCV infection, which is pegylated interferon-alfa as combination therapy with ribavirin for 24-48 weeks of treatment, is effective in only part of the patients and is often associated with severe adverse effects leading to discontinuation of treatment and dose modifications.

A number of compounds with direct activity are currently under clinical development, incl. BI 201335. BI 201335 works by preventing the Hepatitis C virus from replicating by binding to the HCV protease (enzyme). The main purpose of this clinical trial with BI 201335 is to see how well BI 201335 works and how safe BI 201335 is to use daily in combination with PegIFN and RBV in HCV infected patients.

Condition	Intervention	Phase
Hepatitis C, Chronic	Drug: BI 201335	Phase II

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Ribavirin Interferons

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Parallel Assignment, Safety/Efficacy Study
Official Title:	Antiviral Effect, Safety and Pharmacokinetics of Once Daily BI 201335 NA in Hepatitis C Virus Genotype 1 Infected Treatment-naïve Patients for 24 Weeks as Combination Therapy With Pegylated Interferon-¿ 2a and Ribavirin (Double-Blinded, Randomised, Placebo-Controlled, Phase II)

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

SVR

Secondary Outcome Measures:

W2VR, W4VR, EVR, cEVR, ETR1335, ETR1335+4, ETR+12, time to VL BLD, time to loss of virological response

Estimated Enrollment:	700
Study Start Date:	October 2008
Estimated Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

chronic HCV GT1;
therapy-naive to IFN, PegIFN, or RBV;
HCV VL >=100,000 IU/mL
Liver biopsy within 2 years prior to study enrolment showing necroinflammatory activity or presence of fibrosis
Normal retinal finding on fundoscopy within 6 months prior to Day 1
age 18-65 years
Females and males with adequate contraception

Exclusion Criteria:

Mixed genotype (1/2, 1/3, or 1/4), diagnosed by genotypic testing at screening Previous treatment with protease inhibitor
Evidence of liver disease due to causes other than chronic HCV infection
HIV-1 or HIV-2 positive
HBV positive
Decompensated liver disease, or history of decompensated liver disease
Active or suspected malignancy or history of malignancy within thte last 5 years
History of alcohol or drug abuse within the past 12 months.
Usage of any investigational drug within 30 days prior t enrolment, or 5 half-lives, whichever is longer
Known hypersensitivity to any ingredient of the study drugs
Condition that is defined as one which in the opinion of the investigator may put the patient at risk because of participation in the study or may influence the results of the study or the patient's ability to participate in the study Alpha-fetoprotein value > 100ng/mL at screening; if >20ng/mL and <=100ng/mL, patients can be included if there is no evidence of liver cancer in two congruent imaging studies
Total bilirubin > 1.5x ULN wiht ratio of direct/indirect >1.
ALT or AST levels > 5x ULN
INR prolonged to >1.5x ULN
Exclusion criteria related to PegIFN and/or RBV restrictions.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00774397

Contacts

Contact: Boehringer Ingelheim Study Coordinator

800-542-6257 ext Option 4

clintriage.rdg@boehringer-ingelheim.com

Show 45 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

Responsible Party:	Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers:	1220.5
Study First Received:	October 16, 2008
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00774397
Health Authority:	Argentina: A.N.M.A.T. (Administracion Nacional de Medicamentos, Alimentos y Tecnología Médica).; Australia: Responsible Ethics Committee; Austria: Federal Office for Safety in Health Care; Canada: Health Canada - Therapeutic Products Directorate; Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10; France: Afssaps - French Health Products Safety Agency; Germany: BfArM (Bundesagentur für Arzneimittel und Medizinalproduke); Great Britain: MHRA; Korea, Republic of: Korea Food and Drug Administration; Netherlands: Central Committee on Research Involving Human Subjects (CCMO); Portugal: INFARMED National Authority of Medicines and Health Products, IP; Romania: National Medicines Agency, Bucharest; Spain: Spanish Agency for Medicines and Health Products; Switzerland: Swissmedic; United States: Food and Drug Administration

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic

Interferons
Ribavirin
Hepatitis, Viral, Human
Hepatitis C
Hepatitis C, Chronic

Additional relevant MeSH terms:

RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on January 16, 2009