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
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ClinicalTrials.gov Identifier: NCT01323244 |
Recruitment Status
:
Completed
First Posted
: March 25, 2011
Last Update Posted
: April 4, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatitis C | Drug: TMC435 | Phase 3 |
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 |
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
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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
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- The proportion of participants with sustained viral response [ Time Frame: 12 weeks after planned end of treatment ]
- The proportion of participants with sustained viral response [ Time Frame: 24 weeks after planned end of treatment ]
- Number of participants with HCV RNA level >1000 IU/mL [ Time Frame: Week 4 ]
- Number of participants with viral breakthrough [ Time Frame: Through Week 48 ]
- Number of participants with viral relapse [ Time Frame: Through Week 48 ]
- Number of participants with normalized alanine aminotransferase levels [ Time Frame: Through Week 48 ]
- Number of participants with on-treatment failure [ Time Frame: Through Week 48 ]
- Number of participants affected by an adverse event [ Time Frame: Through Week 48 ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01323244

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 |
Study Director: | Janssen R&D Ireland Clinical Trial | Janssen R&D Ireland |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 Key Record Dates |
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 |