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A Study of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin in Participants With Chronic HCV Infection

Information source: Janssen-Cilag International NV
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C, Chronic; Infection

Intervention: TMC435 (Drug); Pegylated interferon alfa-2a (PegIFN╬▒-2a) (Drug); Ribavirin (RBV) (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Janssen-Cilag International NV

Official(s) and/or principal investigator(s):
JJanssen-Cilag International NV Clinical Trial, Study Director, Affiliation: Janssen-Cilag International NV

Summary

The purpose of this study is to evaluate the efficacy, tolerability, and safety of 12-weeks of treatment with TMC435 plus pegylated interferon alfa-2a (PegIFN╬▒-2a) and ribavirin (RBV) in previously untreated adult participants with genotype 1 or genotype 4 chronic Hepatitis C Virus (HCV) infection.

Clinical Details

Official title: A Phase 3, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin Administered for 12 Weeks in Treatment-Na´ve Subjects With Chronic Genotype 1 or Genotype 4 HCV Infection

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The proportion (percentage) of participants infected wtih genotype 1 HCV with a sustained virologic response 12 weeks after planned end of treatment (SVR12)

Secondary outcome:

The proportion (percentage) of participants infected wtih genotype 4 HCV with a sustained virologic response 12 weeks after planned end of treatment (SVR12)

The proportion (percentage) of participants who achieve rapid virologic response (RVR)

The proportion (percentage) of participants who achieve virologic response at Week 2 (W2VR)

The proportion (percentage) of participants with sustained virologic response 24 weeks after planned end of treatment (SVR24)

The proportion (percentage) of participants with sustained virologic response 12 weeks after planned end of treatment (SVR12)

The proportion (percentage) of participants with > or = 2 log decrease in hepatitis C virus (HCV) RNA at each time point

The proportion (percentage) of participants with hepatitis C virus (HCV) RNA < 25 IU/mL undetectable at each time point

The proportion (percentage) of participants with viral breakthrough

The proportion (percentage) of participants with viral relapse

Change from Baseline in the Hepatitis C Treatment Symptom & Impact Questionnaire (HCV SIQ) symptom and impact scores

Change from Baseline in The Fatigue Severity Scale (FSS) total score

Change from Baseline in The Center for Epidemiologic Studies Depression Scale (CES-D) score

Change from Baseline in The Work Productivity and Activity Index (WPAI) for Hepatitis C missed work time, daily activity impairment, and productivity scores

Change from Baseline in The EuroQol 5 Dimension (EQ5D) Visual Analog Scale (VAS) valuation index, and Descriptive System scores

The proportion (percentage) of participants with normalized alanine aminotransferase (ALT) levels

Change from Screening in liver disease stage assessment

The number of participants reporting adverse events as a measure of safety and tolerability

Detailed description: This is a multicenter, international study where all participants will receive triple therapy with the following 3 medications: TMC435 also referred to as simeprevir (formerly known as TMC435350) which is an investigational medication in development for the treatment of chronic hepatitis C virus (HCV) infection, pegylated interferon alfa-2a (PegIFN╬▒-2a), and ribavirin (RBV). PegIFN╬▒-2a and RBV are commercially available therapies for HCV infection. Participants will receive treatment with TMC435, PegIFN╬▒-2a, and RBV for 12 weeks. If blood levels of HCV ribonucleic acid (RNA) monitored at Weeks 2, 4, and 8 are below 25 IU/mL, all treatment will be stopped at Week 12. If HCV RNA values are above 25 IU/mL at Weeks 2, 4, or 8, treatment with PegIFN╬▒-2a and RBV will continue for an additional 12 weeks (up to Week 24) unless protocol-specified stopping criteria are met at Week 4 or 12, at which time all treatment will be discontinued. The study will be conducted in 3 phases: a screening phase of maximum 6 weeks, a treatment phase extending from Day 1 (baseline) up to 12 or 24 weeks depending on the response to treatment, and a posttreatment follow-up period of 24 weeks after the participant's last planned dose of study drug. The duration of the participation (excluding screening phase) for each participant will vary between 36 and 48 weeks, depending on the response to treatment. Blood samples for laboratory analysis will be obtained from participants at protocol-specified time points during the study and participant safety will be monitored throughout the study.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- treatment-naïve with confirmed chronic Hepatitis C Virus (HCV) infection

- liver biopsy performed within 2 years prior to screening or non-invasive confirmation

of the liver disease stage (by transient elastography) performed within 6 months prior to screening

- liver disease stage equivalent to Metavir Score F0-F2 (no fibrosis, or portal

fibrosis without or with few septa) Exclusion Criteria:

- Participants with advanced liver disease equivalent to Metavir score F3-F4 (bridging

fibrosis or cirrhosis), with hepatic decompensation, with any liver disease of non-HCV etiology, and/or with a non-genotype 1 or non-genotype 4 hepatitis C, hepatitis B or HIV co-infection will be excluded from the study

Locations and Contacts

Linz, Austria

Wien, Austria

Brussels, Belgium

Brussel, Belgium

Edegem, Belgium

Clichy, France

Limoges Cedex, France

Orleans, France

St Laurent Du Var, France

Berlin, Germany

D├╝sseldorf, Germany

Frankfurt, Germany

Hamburg, Germany

W├╝rzburg, Germany

Riyadh, Saudi Arabia

Barcelona, Spain

Madrid, Spain

Valencia, Spain

Valme, Spain

Glasgow, United Kingdom

London, United Kingdom

Additional Information

Starting date: September 2013
Last updated: June 15, 2015

Page last updated: August 23, 2015

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