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 |
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Recruitment Status :
Completed
First Posted : March 25, 2011
Last Update Posted : April 4, 2016
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Sponsor:
Janssen R&D Ireland
Information provided by (Responsible Party):
Janssen R&D Ireland
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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 |
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 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 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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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 |
Primary Outcome Measures :
- The proportion of participants with sustained viral response [ Time Frame: 12 weeks after planned end of treatment ]
Secondary Outcome Measures :
- 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 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
| 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.
Information from the National Library of Medicine
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
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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 |
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:
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TMC435-TiDP16-C213 TMC435-C213 TMC435 HCV Hepatitis C |
Additional relevant MeSH terms:
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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 |