Clinical trial NCT01349465: 3-year Follow-up Study in Patients Previously Treated With TMC435-Containing Regimen for the Treatment of Hepatitis C Virus Infection
Official title: A Prospective 3-Year Follow-up Study in Subjects Previously Treated in a Phase IIb or Phase III Study With a TMC435-Containing Regimen for the Treatment of Hepatitis C Virus (HCV) Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C
Keywords: Hepatitis C
Hepatitis
TMC435
Liver disease
Virus Infection
Lead sponsor: Janssen R&D Ireland
Sponsor class: INDUSTRY
First posted: 2011-05-06
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to investigate durability of SVR in chronic HCV patients who achieved SVR in the previous study with TMC435-containing regimen and time for resistance associated mutations to return to baseline in chronic HCV patients who did not achieve SVR in the previous study with TMC435-containing regimen.

Detailed description: This is a 3-year follow-up study in patients who completed the last post-therapy follow-up visit of the previous Phase IIb \[NCT00882908, NCT00980330\] or Phase III \[NCT01289782, NCT01290679, NCT01281839\] study in which they received TMC435, in combination with pegylated interferon and ribavirin, for the treatment of hepatitis C infection. The entire study duration for each patients will be approximately 36 months. The medical follow-up of the patients will be performed according to the local standard of care. This study will evaluate the levels of hepatitis C virus in the blood circulation, as well as safety and alpha-fetoprotein testing and the change in sequence of HCV NS3/4A region over time in patients with confirmed detectable HCV RNA at last post-therapy follow-up visit of the previous TMC435 study. In this study the development of liver disease progression will also be assessed. No medication will be administered in this study.

Eligibility criteria: Inclusion Criteria:

* Have previously participated in a Phase IIb or Phase III study
* Must have received at least one dose of TMC435 in that study
* Has completed the last post-therapy follow-up visit of the previous (LPVPS) study

Exclusion Criteria:

* Must be currently enrolled or plan to enroll in another study with an investigational drug or invasive investigational medical device
* Have received antiviral or immunomodulating treatment, including therapeutic vaccines, for hepatitis C virus (HCV) between LPVPS and the screening visit of present study

Primary outcomes:
measure: Percentage of Participants Maintaining SVR at the Last Available Visit
timeFrame: Last Available Visit (Month 36 for subjects completing the study)
measure: Overall Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA at the Last Visit of the Previous Study
timeFrame: Baseline and Month 36
measure: Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA (With Q80K at Baseline) at the Last Visit of the Previous Study
timeFrame: Baseline and Month 36
measure: Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA (Without Q80K at Baseline) at the Last Visit of the Previous Study
timeFrame: Baseline and Month 36
Secondary outcomes:
measure: Percentage of Participants With Late Viral Relapse
timeFrame: End of study (at month 36)
measure: Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
timeFrame: End of study (at month 36)
Other outcomes:
Locations:
city: Bakersfield
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Jacksonville
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: New Orleans
country: United States
state: Louisiana
city: Saint Paul
country: United States
state: Minnesota
city: Tupelo
country: United States
state: Mississippi
city: Chapel Hill
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: San Antonio
country: United States
state: Texas
city: Antwerpen
country: Belgium
city: Brugge
country: Belgium
city: Brussels
country: Belgium
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Calgary
country: Canada
state: Alberta
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
city: Creteil
country: France
city: Grenoble
country: France
city: Lyon
country: France
city: Nice N/A
country: France
city: Paris
country: France
city: Vandoeuvre-Les-Nancy
country: France
city: Berlin
country: Germany
city: Düsseldorf
country: Germany
city: Frankfurt A. M.
country: Germany
city: Freiburg
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Kiel
country: Germany
city: Köln
country: Germany
city: Würzburg
country: Germany
city: Bialystok
country: Poland
city: Bydgoszcz
country: Poland
city: Czeladz
country: Poland
city: Myslowice
country: Poland
city: Warszawa
country: Poland
city: Moscow
country: Russian Federation
city: Nizhny Novgorod
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
Study officials:
affiliation: Janssen R&D Ireland
name: Janssen R&D Ireland Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Zoulim F, Moreno C, Lee SS, Buggisch P, Horban A, Lawitz E, Corbett C, Lenz O, Fevery B, Verbinnen T, Shukla U, Jessner W. A 3-year follow-up study after treatment with simeprevir in combination with pegylated interferon-alpha and ribavirin for chronic hepatitis C virus infection. Virol J. 2018 Jan 30;15(1):26. doi: 10.1186/s12985-018-0936-4.