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

Sponsor

Janssen R&D Ireland (Industry)

Overall Status

Completed

CT.gov ID

NCT01323244

Collaborator

(none)

142

Enrollment

Locations

Arm

Duration (Months)

1.9

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Actual Enrollment :

142 participants

Allocation:

N/A

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 :

Dec 1, 2011

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

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

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

Primary Outcome Measures

The proportion of participants with sustained viral response [12 weeks after planned end of treatment]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	City	State	Country
1	Bakersfield	California	United States
2	Los Angeles	California	United States
3	San Diego	California	United States
4	Englewood	Colorado	United States
5	Jacksonville	Florida	United States
6	Orlando	Florida	United States
7	New Orleans	Louisiana	United States
8	Jackson	Mississippi	United States
9	Tupelo	Mississippi	United States
10	Chapel Hill	North Carolina	United States
11	Cincinnati	Ohio	United States
12	Philadelphia	Pennsylvania	United States
13	Dallas	Texas	United States
14	Houston	Texas	United States
15	San Antonio	Texas	United States
16	Buenos Aires		Argentina
17	Rosario, Santa Fe		Argentina
18	Adelaide		Australia
19	Concord		Australia
20	Melbourne		Australia
21	Wentworthville		Australia
22	Woolloongabba N/A		Australia
23	Wien		Austria
24	Antwerpen		Belgium
25	Brussels		Belgium
26	Gent		Belgium
27	Sao Paulo		Brazil
28	Sofia		Bulgaria
29	Toronto	Ontario	Canada
30	Montreal	Quebec	Canada
31	Grenoble		France
32	Lyon		France
33	Nice Cedex 03 N/A		France
34	Paris Cedex 12		France
35	Berlin		Germany
36	Frankfurt A. M.		Germany
37	Hamburg		Germany
38	Kiel		Germany
39	Münster		Germany
40	Ulm		Germany
41	Würzburg		Germany
42	Haifa		Israel
43	Zefat		Israel
44	Monterrey		Mexico
45	Amsterdam		Netherlands
46	Rotterdam		Netherlands
47	Auckland		New Zealand
48	Christchurch		New Zealand
49	Bydgoszcz		Poland
50	Chorzów		Poland
51	Czeladz		Poland
52	Kielce		Poland
53	Myslowice		Poland
54	Warschau		Poland
55	Coimbra		Portugal
56	Lisboa		Portugal
57	San Juan		Puerto Rico
58	Bucuresti		Romania
59	Moscow		Russian Federation
60	Saint-Petersburg		Russian Federation
61	Samara		Russian Federation
62	Smolensk		Russian Federation
63	St Petersburg		Russian Federation
64	Stavropol		Russian Federation
65	Barcelona		Spain
66	Madrid		Spain
67	Sevilla N/A		Spain
68	Valencia		Spain
69	Donetsk		Ukraine
70	Kyiv		Ukraine
71	Vinnitsa		Ukraine
72	Birmingham		United Kingdom
73	London		United Kingdom