A Study of TMC435 in Combination With Peginterferon Alfa-2A and Ribavirin for Hepatitis C Virus Genotype-1 Infected Patients Who Participated in a Control Group of a TMC435 Study

NCT ID: NCT01323244

Last Updated: 2016-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2015-03-31

Brief Summary

The purpose of this study is to investigate the efficacy of a treatment with TMC435 in combination with peginterferon alfa-2a and ribavirin in patients who did not clear their hepatitis C infection with peginterferon alfa-2a and ribavirin alone within a previous trial conducted by Tibotec, or who participated in Tibotec trials in which antivirals directed against hepatitis C virus (HCV) were evaluated for short periods of time.

Detailed Description

This is a roll over trial of TMC435 for patients with genotype-1 HCV infection who participated in the control (placebo; substance containing no active medication) group of a TMC435 trial or who received a treatment for up to 14 days with antivirals directed against HCV in a previous Tibotec trial. Patients in this study will receive TMC435 in combination with peginterferon alfa-2a (Pegasys) and ribavirin (Copegus) followed by peginterferon alfa-2a and ribavirin alone. The total treatment duration will be 24 or 48 weeks, depending on how the patients respond to treatment and which was their previous response to peginterferon alfa-2a and ribavirin alone. The study doctor will inform each patient about how to take their study medication and when they should stop taking it. After a patient stops taking study medication, they will contiue to come to the doctor's office for study visits until 24 weeks (in some cases up to 48 weeks) after end of treatment. The total duration of the study is 78 weeks (including screening). Patients will be monitored for safety throughout the study. Study assessments at each visit may include but are not limited to: blood and urine collection for testing, electrocardiogram (ECG) assessments (a measurement of the electrical activity of the heart) and physical examinations. TMC435 will be taken as an oral capsule of 150 mg once per day. Peginterferon (Pegasys) will be given as an injection of 180 µg once each week. Ribavirin will be taken as tablets (Copegus) twice each day and the dose will depend on patient's body weight.

Conditions

Hepatitis C

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TMC435

TMC435 Type=exact number unit=mg number=150 form=capsule route=oral use once daily for 12 weeks in addition to peginterferon alfa-2a peginterferon and ribavirin for 24 or 48 weeks

Group Type: EXPERIMENTAL

TMC435

Intervention Type: DRUG

Type=exact number, unit=mg, number=150, form=capsule, route=oral use, once daily for 12 weeks in addition to peginterferon alfa-2a peginterferon and ribavirin for 24 or 48 weeks

Interventions

TMC435

Type=exact number, unit=mg, number=150, form=capsule, route=oral use, once daily for 12 weeks in addition to peginterferon alfa-2a peginterferon and ribavirin for 24 or 48 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients who participated in the placebo arm of a TMC435 study who did not achieve undetectable HCV RNA levels at end of treatment or who relapsed within 1 year after end of treatment OR Patients who received short-term direct-acting antiviral therapy in a Tibotec-sponsored study.
• Liver disease stage documented by liver biopsy is required within 3 years prior to screening unless contraindicated.

Exclusion Criteria

• Infection with human immunodeficiency virus.
• Liver disease not related to hepatitic C infection.
• Significant laboratory abnormalities or other active diseases.
• Pregnant or planning to become pregnant.
• Prematurely stopped medication in previous TMC435 study for non-compliance or for safety reasons.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen R&D Ireland

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen R&D Ireland Clinical Trial

Role: STUDY_DIRECTOR

Janssen R&D Ireland

Locations

Bakersfield, California, United States

Los Angeles, California, United States

San Diego, California, United States

Englewood, Colorado, United States

Jacksonville, Florida, United States

Orlando, Florida, United States

New Orleans, Louisiana, United States

Jackson, Mississippi, United States

Tupelo, Mississippi, United States

Chapel Hill, North Carolina, United States

Cincinnati, Ohio, United States

Philadelphia, Pennsylvania, United States

Dallas, Texas, United States

Houston, Texas, United States

San Antonio, Texas, United States

Buenos Aires, , Argentina

Rosario, Santa Fe, , Argentina

Adelaide, , Australia

Concord, , Australia

Melbourne, , Australia

Wentworthville, , Australia

Woolloongabba, , Australia

Vienna, , Austria

Antwerp, , Belgium

Brussels, , Belgium

Ghent, , Belgium

São Paulo, , Brazil

Sofia, , Bulgaria

Toronto, Ontario, Canada

Montreal, Quebec, Canada

Grenoble, , France

Lyon, , France

Nice Cedex 03 N/A, , France

Paris, , France

Berlin, , Germany

Frankfurt A. M., , Germany

Hamburg, , Germany

Kiel, , Germany

Münster, , Germany

Ulm, , Germany

Würzburg, , Germany

Haifa, , Israel

Safed, , Israel

Monterrey, , Mexico

Amsterdam, , Netherlands

Rotterdam, , Netherlands

Auckland, , New Zealand

Christchurch, , New Zealand

Bydgoszcz, , Poland

Chorzów, , Poland

Czeladź, , Poland

Kielce, , Poland

Mysłowice, , Poland

Warsaw, , Poland

Coimbra, , Portugal

Lisbon, , Portugal

San Juan, , Puerto Rico

Bucharest, , Romania

Moscow, , Russia

Saint Petersburg, , Russia

Samara, , Russia

Smolensk, , Russia

Stavropol, , Russia

Barcelona, , Spain

Madrid, , Spain

Seville, , Spain

Valencia, , Spain

Donetsk, , Ukraine

Kyiv, , Ukraine

Vinnitsa, , Ukraine

Birmingham, , United Kingdom

London, , United Kingdom

Countries

United States; Argentina; Australia; Austria; Belgium; Brazil; Bulgaria; Canada; France; Germany; Israel; Mexico; Netherlands; New Zealand; Poland; Portugal; Puerto Rico; Romania; Russia; Spain; Ukraine; United Kingdom

References

Gane EJ, DeJesus E, Janczewska E, George J, Diago M, Da Silva MH, Reesink H, Nikitin I, Hinrichsen H, Bourgeois S, Ferenci P, Shukla U, Kalmeijer R, Lenz O, Fevery B, Corbett C, Beumont M, Jessner W. Simeprevir with peginterferon alpha-2a/ribavirin for chronic hepatitis C virus genotype 1 infection in treatment-experienced patients: an open-label, rollover study. BMC Infect Dis. 2017 Jun 2;17(1):389. doi: 10.1186/s12879-017-2444-3.

Reference Type: DERIVED

PMID: 28577353 (View on PubMed)

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_7051&studyid=1054&filename=CR017983_CSR.pdf

A Study of TMC435 in Combination with Peginterferon Alfa-2A and Ribavirin for Hepatitis C Virus Genotype-1 Infected Patients who Participated in a Control Group of a TMC435 Study.

Other Identifiers

TMC435-TiDP16-C213

Identifier Type: OTHER

Identifier Source: secondary_id

CR017983

Identifier Type: -

Identifier Source: org_study_id