Clinical trial NCT01323244: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C
Keywords: TMC435-TiDP16-C213
TMC435-C213
TMC435
HCV
Hepatitis C
Lead sponsor: Janssen R&D Ireland
Sponsor class: INDUSTRY
First posted: 2011-03-25
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The proportion of participants with sustained viral response
timeFrame: 12 weeks after planned end of treatment
Secondary outcomes:
measure: The proportion of participants with sustained viral response
timeFrame: 24 weeks after planned end of treatment
measure: Number of participants with HCV RNA level >1000 IU/mL
timeFrame: Week 4
measure: Number of participants with viral breakthrough
timeFrame: Through Week 48
measure: Number of participants with viral relapse
timeFrame: Through Week 48
measure: Number of participants with normalized alanine aminotransferase levels
timeFrame: Through Week 48
measure: Number of participants with on-treatment failure
timeFrame: Through Week 48
measure: Number of participants affected by an adverse event
timeFrame: Through Week 48
Other outcomes:
Locations:
city: Bakersfield
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: Englewood
country: United States
state: Colorado
city: Jacksonville
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: New Orleans
country: United States
state: Louisiana
city: Jackson
country: United States
state: Mississippi
city: Tupelo
country: United States
state: Mississippi
city: Chapel Hill
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Buenos Aires
country: Argentina
city: Rosario, Santa Fe
country: Argentina
city: Adelaide
country: Australia
city: Concord
country: Australia
city: Melbourne
country: Australia
city: Wentworthville
country: Australia
city: Woolloongabba N/A
country: Australia
city: Wien
country: Austria
city: Antwerpen
country: Belgium
city: Brussels
country: Belgium
city: Gent
country: Belgium
city: Sao Paulo
country: Brazil
city: Sofia
country: Bulgaria
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Grenoble
country: France
city: Lyon
country: France
city: Nice Cedex 03 N/A
country: France
city: Paris Cedex 12
country: France
city: Berlin
country: Germany
city: Frankfurt A. M.
country: Germany
city: Hamburg
country: Germany
city: Kiel
country: Germany
city: Münster
country: Germany
city: Ulm
country: Germany
city: Würzburg
country: Germany
city: Haifa
country: Israel
city: Zefat
country: Israel
city: Monterrey
country: Mexico
city: Amsterdam
country: Netherlands
city: Rotterdam
country: Netherlands
city: Auckland
country: New Zealand
city: Christchurch
country: New Zealand
city: Bydgoszcz
country: Poland
city: Chorzów
country: Poland
city: Czeladz
country: Poland
city: Kielce
country: Poland
city: Myslowice
country: Poland
city: Warschau
country: Poland
city: Coimbra
country: Portugal
city: Lisboa
country: Portugal
city: San Juan
country: Puerto Rico
city: Bucuresti
country: Romania
city: Moscow
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Samara
country: Russian Federation
city: Smolensk
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Stavropol
country: Russian Federation
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Sevilla N/A
country: Spain
city: Valencia
country: Spain
city: Donetsk
country: Ukraine
city: Kyiv
country: Ukraine
city: Vinnitsa
country: Ukraine
city: Birmingham
country: United Kingdom
city: London
country: United Kingdom
Study officials:
affiliation: Janssen R&D Ireland
name: Janssen R&D Ireland Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.