Clinical Trial Protocol Registry

Trial information

An Observational Study on Long-Term Persistence of Resistant Mutations And Durability of Sustained Virological Response in Patients With Chronic Hepatitis C Treated With Direct Acting Antiviral (DAA)- Containing Regimens

Status:
Recruiting
Protocol number:
NV22688
Sponsor:
Hoffmann-La Roche
Company division:
Pharmaceutical
Official Scientific Title:
A long-term monitoring study to evaluate the persistence of direct antiviral (DAA) treatment resistant mutations or the durability of sustained virological response (SVR) in patients treated with DAA containing regimens for chronic hepatitis C infections (CHC)
Brief summary:
This observational long-term follow-up study will assess the persistence of direct acting antiviral (DAA) resistant mutations and the durability of sustained virological response in patients with chronic hepatitis C who have participated in a Roche DAA treatment protocol. Up to 5 scheduled monitoring visits for blood sampling during an observational period of up to 36 months. Target sample size is 500.
Study phase:
II
Study type:
Interventional; Open label study
Conditions:
  • Hepatitis C, Chronic
Primary outcome:
  1. Persistence of DAA-associated resistant mutations following discontinuation of DAA therapy Time frame: 18 months
  2. Durability of sustained virological response (SVR-24), defined as undetectable HCV RNA measured by Roche COBAS TaqMan HCV Test Time frame: 36 months
  3. Collecting of serum specimens from patients with partial viral response or viral load rebound of viral response while on RO5024048 treatment, to monitor for resistance mutations in viral RNA Time frame: 18 months
Inclusion criteria:
  • adult patients, >/=18 years of age
  • chronic hepatitis C
  • participation in Roche DAA treatment protocol for CHC infection
  • DAA-associated resistant mutations persisting through to last evaluation in donor protocol , or partial viral response or viral load rebound while on RO5024048 treatment, or sustained virological response >/= 20 weeks after last dose of study medication in donor study
Exclusion criteria:
  • For patients participating in DAA resistance monitoring: Initiation of treatment after participation in the donor protocol for which there is evidence of cross-resistance to donor protocol DAA
  • For patients participating in DAA SVR durability: Treatment with any anti-HVC therapy since establishing SVR in the donor study
Gender:
Males or Females
Age limits:
Min: 18 years Max: N/A N/A
Accepts healthy volunteers:
No
Anticipated start date:
September, 2010
Trial registration date:
29.03.2010
Date last updated:
04.06.2013
This trial is being conducted at the following locations:
Australia
  • ADELAIDE
  • BRISBANE
  • DARLINGHURST
  • MELBOURNE
  • SYDNEY
AUSTRALIA
  • Kingswood, New S
  • HERSTON, Queen
  • WOOLLOONGABBA, Queen
AUSTRIA
  • Wien
Brazil
  • PORTO ALEGRE
  • RIBEIRAO PRETO
BRAZIL
  • Salvador, BA
Canada
  • CALGARY, AB
  • EDMONTON, AB
  • VANCOUVER, BC
  • VICTORIA, BC
  • WINNIPEG, MB
  • LONDON, ON
  • OTTAWA, ON
  • TORONTO, ON
CANADA
  • Edmonton, Alber
  • Toronto, Ontar
France
  • CLICHY
  • CRETEIL
  • LILLE
  • MARSEILLE
  • MONTPELLIER
  • NICE
  • PARIS
  • PESSAC
  • TOULOUSE
  • VANDOEUVRE-LES-NANCY
FRANCE
  • Montpellier
  • RENNES
Germany
  • BERLIN
  • FRANKFURT AM MAIN
  • HANNOVER
GERMANY
  • Berlin
  • Hamburg
  • Muenchen
Italy
  • BARI
  • BOLOGNA
  • MILANO
  • PAVIA
  • PISA
  • TORINO
ITALY
  • MILANO
  • Napoli
  • NAPOLI
Mexico
  • GUADALAJARA
MEXICO
  • GUADALAJARA
  • Monterrey
New Zealand
  • AUCKLAND
Poland
  • WARSZAWA
POLAND
  • Bydgoszcz
  • Lodz
  • Myslowice
  • WARSZAWA
Spain
  • BADALONA
  • BARCELONA
  • LA CORUNA
  • LA LAGUNA
  • MADRID
  • SANTANDER
  • SEVILLA
  • VALENCIA
SPAIN
  • BARCELONA, BARCE
  • Granada, GRANA
  • Palma de Mallorca, ISLAS
  • MADRID, MADRI
  • Pontevedra, PONTE
U.S.A.
  • LA JOLLA, CA
  • SACRAMENTO, CA
  • SAN DIEGO, CA
  • SAN FRANCISCO, CA
  • BRADENTON, FL
  • ATLANTA, GA
  • MARIETTA, GA
  • CHICAGO, IL
  • INDIANAPOLIS, IN
  • NEW ORLEANS, LA
  • KANSAS CITY, MO
  • LEBANON, NH
  • MANHASSET, NY
  • SAN JUAN, PR
  • PROVIDENCE, RI
  • FORT SAM HOUSTON, TX
  • HOUSTON, TX
  • RICHMOND, VA
United Kingdom
  • LONDON
UNITED KINGDOM
  • Dundee
  • London
  • LONDON
  • Manchester
  • Nottingham
UNITED STATES
  • Long Beach, CA
  • Sacramento, CA
  • Aurora, CO
  • Decatur, GA
  • Honolulu, HI
  • Kansas City, KS
  • Detroit, MI
  • Newark, NJ
  • New York, NY
  • Nashville, TN
  • San Antonio, TX
  • Newport News, VA
  • Vancouver, WA

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