Clinical trial NCT00535847: A Rollover Study for Subjects Participating in the Control Arm of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Whose Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Did Not Respond to Therapy
Official title: A Phase 2 Rollover Protocol of Telaprevir (VX-950) in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Enrolled in the Control Group (Group A) of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Who Did Not Achieve or Maintain an Undetectable HCV RNA Level Through Sustained Viral Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C
Keywords: Genotype 1
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
Collaborators: name: Tibotec, Inc
First posted: 2007-09-26
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To provide access to a telaprevir-based treatment to subjects of the Control Group of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479), and VX05-950-104EU (NCT00372385) who stopped treatment due to inadequate response to treatment. Safety, tolerability, and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels will be collected.


Eligibility criteria: Inclusion Criteria:

* Enrolled in the control arm of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479) or VX05-950-104EU (NCT00372385)

Primary outcomes:
measure: Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Treatment
timeFrame: 24 weeks after the completion of treatment (up to Week 72)
measure: Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline through Week 48
Secondary outcomes:
measure: Percentage of Prior Relapsers With Undetectable HCV RNA
timeFrame: 24 weeks after the completion of treatment (up to Week 72)
measure: Percentage of Subjects With End of Treatment Response
timeFrame: End of treatment (up to Week 48)
measure: Percentage of Subjects With Undetectable HCV RNA at Week 48 After Completion of Treatment Among Subjects Who Completed Assigned Treatment
timeFrame: 48 weeks after completion of treatment (up to Week 96)
measure: Cross Tabulation of Extended Rapid Viral Response (eRVR) and Sustained Viral Response (SVR) in With Prior Response
timeFrame: Baseline up to Week 72
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
facility: Kaiser Permanente Internal Medicine
state: California
city: San Francisco
country: United States
state: California
city: Denver
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
city: Englewood
country: United States
facility: South Denver Gastroenterology
state: Colorado
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: Borland-Groover Clinic
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Miami
country: United States
facility: University of Miami Center for Liver Diseases
state: Florida
city: Sarasota
country: United States
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Baton Rouge
country: United States
facility: Digestive and Liver Disease Clinic
state: Louisiana
city: Portland
country: United States
facility: Virology Treatment Center, Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: St Louis
country: United States
facility: St Louis University
state: Missouri
city: Omaha
country: United States
facility: The Nebraska Medical Center
state: Nebraska
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Columbia
country: United States
facility: Columbia Gastroenterology Associates, PA
state: South Carolina
city: Germantown
country: United States
facility: Memphis Gastroenterology Group
state: Tennessee
city: Dallas
country: United States
facility: Liver Institute at Methodist Dallas
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
facility: Alamo Medical Research
state: Texas
city: Annandale
country: United States
state: Virginia
city: Charlottesville
country: United States
facility: University of Virginia Health Systems
state: Virginia
city: Fairfax
country: United States
facility: Metropolitan Research
state: Virginia
city: Richmond
country: United States
facility: McGuire DVAMC
state: Virginia
city: Vienna
country: Austria
city: Calgary
country: Canada
facility: University of Calgary Medical Clinic
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Vancouver
country: Canada
facility: University of British Columbia Vancouver General Hospital
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Toronto
country: Canada
state: Ontario
city: Creteil
country: France
facility: Hospital Henri Mondor
city: Lyon
country: France
city: Nice
country: France
city: Paris
country: France
city: Pessac
country: France
city: Vandoeuvre
country: France
city: Berlin
country: Germany
city: Bonn
country: Germany
facility: Universitatsklinikum Bonn
city: Cologne
country: Germany
facility: University of Cologne
city: Dusseldorf
country: Germany
facility: Uniklinik Duesseldorf
city: Frankfurt
country: Germany
city: Hannover
country: Germany
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus MC Medical Center
city: Santurce
country: Puerto Rico
facility: Fundacion de Investigation de Diego
city: London
country: United Kingdom
Study officials:
affiliation: Vertex Pharmaceuticals Incorporated
name: Nathalie Adda, MD
role: STUDY_DIRECTOR
References: