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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Hepatitis C	Drug: TMC435	Phase 3

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.

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	142 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Phase III, Open-Label, Single Arm, Rollover Trial of TMC435 in Combination With Peginterferon Alpha-2A and Ribavirin for HCV Genotype-1 Infected Subjects Who Participated in the Placebo Group of a Phase II/III TMC435 Study, or Who Received DAA Treatment in a Tibotec-Sponsored Phase I Study.
Study Start Date :	December 2011
Actual Primary Completion Date :	March 2015
Actual Study Completion Date :	March 2015

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: 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	Drug: 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

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. The proportion of participants with sustained viral response [ Time Frame: 12 weeks after planned end of treatment ]

Secondary Outcome Measures :

1. The proportion of participants with sustained viral response [ Time Frame: 24 weeks after planned end of treatment ]
2. Number of participants with HCV RNA level >1000 IU/mL [ Time Frame: Week 4 ]
3. Number of participants with viral breakthrough [ Time Frame: Through Week 48 ]
4. Number of participants with viral relapse [ Time Frame: Through Week 48 ]
5. Number of participants with normalized alanine aminotransferase levels [ Time Frame: Through Week 48 ]
6. Number of participants with on-treatment failure [ Time Frame: Through Week 48 ]
7. Number of participants affected by an adverse event [ Time Frame: Through Week 48 ]

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 99 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Hide Study Locations

Locations

United States, California
Bakersfield, California, United States
Los Angeles, California, United States
San Diego, California, United States
United States, Colorado
Englewood, Colorado, United States
United States, Florida
Jacksonville, Florida, United States
Orlando, Florida, United States
United States, Louisiana
New Orleans, Louisiana, United States
United States, Mississippi
Jackson, Mississippi, United States
Tupelo, Mississippi, United States
United States, North Carolina
Chapel Hill, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Texas
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Argentina
Buenos Aires, Argentina
Rosario, Santa Fe, Argentina
Australia
Adelaide, Australia
Concord, Australia
Melbourne, Australia
Wentworthville, Australia
Woolloongabba N/A, Australia
Austria
Wien, Austria
Belgium
Antwerpen, Belgium
Brussels, Belgium
Gent, Belgium
Brazil
Sao Paulo, Brazil
Bulgaria
Sofia, Bulgaria
Canada, Ontario
Toronto, Ontario, Canada
Canada, Quebec
Montreal, Quebec, Canada
France
Grenoble, France
Lyon, France
Nice Cedex 03 N/A, France
Paris Cedex 12, France
Germany
Berlin, Germany
Frankfurt A. M., Germany
Hamburg, Germany
Kiel, Germany
Münster, Germany
Ulm, Germany
Würzburg, Germany
Israel
Haifa, Israel
Zefat, Israel
Mexico
Monterrey, Mexico
Netherlands
Amsterdam, Netherlands
Rotterdam, Netherlands
New Zealand
Auckland, New Zealand
Christchurch, New Zealand
Poland
Bydgoszcz, Poland
Chorzów, Poland
Czeladz, Poland
Kielce, Poland
Myslowice, Poland
Warschau, Poland
Portugal
Coimbra, Portugal
Lisboa, Portugal
Puerto Rico
San Juan, Puerto Rico
Romania
Bucuresti, Romania
Russian Federation
Moscow, Russian Federation
Saint-Petersburg, Russian Federation
Samara, Russian Federation
Smolensk, Russian Federation
St Petersburg, Russian Federation
Stavropol, Russian Federation
Spain
Barcelona, Spain
Madrid, Spain
Sevilla N/A, Spain
Valencia, Spain
Ukraine
Donetsk, Ukraine
Kyiv, Ukraine
Vinnitsa, Ukraine
United Kingdom
Birmingham, United Kingdom
London, United Kingdom

Sponsors and Collaborators

Janssen R&D Ireland

Investigators

Study Director:	Janssen R&D Ireland Clinical Trial	Janssen R&D Ireland

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

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. 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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 α-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.

Responsible Party:	Janssen R&D Ireland
ClinicalTrials.gov Identifier:	NCT01323244 History of Changes
Other Study ID Numbers:	CR017983; TMC435-TiDP16-C213 ( Other Identifier: Janssen R&D Ireland )
First Posted:	March 25, 2011
Last Update Posted:	April 4, 2016
Last Verified:	March 2016

Keywords provided by Janssen R&D Ireland:

TMC435-TiDP16-C213; TMC435-C213; TMC435; HCV; Hepatitis C

Additional relevant MeSH terms:

Hepatitis; Hepatitis A; Hepatitis C; Liver Diseases; Digestive System Diseases; Hepatitis, Viral, Human; Virus Diseases; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Flaviviridae Infections; Ribavirin	Peginterferon alfa-2a; Interferon-alpha; Simeprevir; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antiviral Agents; Anti-Infective Agents; Immunologic Factors; Physiological Effects of Drugs; Protease Inhibitors; Enzyme Inhibitors