TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFα-2a and Ribavirin in Chronic Hepatitis C Patients Who Were Null or Partial Responders to Prior PegINFα-2a and Ribavirin Therapy

PHASE3CompletedINTERVENTIONAL
Enrollment

771

Participants

Timeline

Start Date

February 29, 2012

Primary Completion Date

April 30, 2014

Study Completion Date

April 30, 2014

Conditions
Hepatitis C
Interventions
DRUG

TMC435

TMC435 Type=exact number, unit=mg, number=150, form=capsule, route=oral use. TVR placebo Form=tablet, route=oral use. TMC435 capsule is taken once daily in addition to 2 TVR placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks.

DRUG

TVR

TVR Type=exact number, unit=mg, number=375, form=tablet, route=oral use. TMC435 placebo Form=capsule, route=oral use. 2 TVR tablets are taken 3 times a day together with 150 mg TMC435 placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks

Trial Locations (137)

Unknown

Bakersfield

San Diego

Aurora

Washington D.C.

Jacksonville

Orlando

West Palm Beach

Atlanta

Honolulu

Chicago

Crestview Hills

New Orleans

Chevy Chase

Jackson

Tupelo

Kansas City

Missoula

Newark

New York

Rochester

Cincinnati

Cleveland

Allentown

Philadelphia

Pittsburgh

Arlington

Houston

Odessa

San Antonio

Falls Church

Bellevue

Seattle

Buenos Aires

Rosario, Santa Fe

Darlinghurst

Greenslopes

Kingswood

Melbourne

Parkville - Vic

Perth

Sydney

Woolloongabba

Linz

Vienna

Brussels

Haine-Saint-Paul, La Louviere

Leuven

Liège

Campinas

Ribeirão Preto

Salvador

São Paulo

Sofia

Varna

Calgary

Edmonton

Vancouver

Toronto

Montreal

Brno

Karlovy Vary

Pilsen

Prague

Copenhagen

Hvidovre

Odense

Grenoble

Lyon

Marseille

Nice

Paris

Pessac

Vandœuvre-lès-Nancy

Berlin

Frankfurt

Freiburg im Breisgau

Hamburg

Hanover

Heidelberg

Kiel

Mainz

München

Stuttgart

Ulm

Würzburg

Alexandroupoli

Athens

Larissa

Budapest

Debrecen

Kaposvár

Pécs

Szeged

Haifa

Jerusalem

Petah Tikva

Ramat Gan

Safed

Tel Aviv

Fredrikstad

Nordbyhagen

Stavanger

Tromsø

Bydgoszcz

Chorzów

Kielce

Lodz

Lublin

Mysłowice

Racibórz

Warsaw

Lisbon

Porto

Santurce

Bucharest

Constanța

Iași

Timișoara

Barcelona

Madrid

Santander

Seville

Valencia

Gothenburg

Lund

Malmo

Örebro

Stockholm

Lugano

Sankt Gallen

Zurich

Glasgow

Leeds

London

Newcastle upon Tyne

Plymouth

Southampton

All Listed Sponsors
lead

Janssen R&D Ireland

INDUSTRY

NCT01485991 - TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFα-2a and Ribavirin in Chronic Hepatitis C Patients Who Were Null or Partial Responders to Prior PegINFα-2a and Ribavirin Therapy | Biotech Hunter | Biotech Hunter