Clinical trial NCT00627926: A Phase 3 Study of Telaprevir in Combination With Pegasys® and Copegus® in Treatment-Naive Subjects With Genotype 1 Hepatitis C Virus (HCV)
Official title: A Phase 3 Study of 2 Dose Regimens of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment-Naive Subjects With Genotype 1 Chronic Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C
Keywords: Genotype 1
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
Collaborators: name: Tibotec Pharmaceutical Limited
First posted: 2008-03-04
Enrollment: 1095
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Phase 3 study to evaluate the efficacy and safety of two dosing regimens of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV).


Eligibility criteria: Inclusion Criteria

* Has not received any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C
* Male and female subjects, 18 to 70 years of age, inclusive
* Genotype 1, chronic hepatitis C with detectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)
* Screening laboratory values, tests, and physical exam within acceptable ranges
* Able and willing to follow contraception requirements
* Able to read and understand, and willing to sign the informed consent form and abide by the study restrictions

Exclusion Criteria

* Subject has any contraindications to Pegasys® or Copegus® therapy
* Evidence of hepatic decompensation in cirrhotic subjects
* History of organ transplant
* History of, or any current medical condition which could impact the safety of the subject in participation in the study

Primary outcomes:
measure: Number of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels 24 Weeks After Last Planned Dose of Study Treatment
timeFrame: 24 weeks after last planned dose of study treatment (up to Week 72)
Secondary outcomes:
measure: Number of Subjects With Undetectable HCV RNA at Week 72
timeFrame: Week 72 (24 weeks after last dose for subjects with a planned treatment duration of 48 weeks and 48 weeks after last dose for subjects with planned treatment duration of 24 weeks)
measure: Number of Subjects Achieving Rapid Viral Response (RVR), Demonstrated by Achieving Undetectable HCV RNA 4 Weeks After Starting Study Treatment
timeFrame: Week 4
measure: Number of Subjects Achieving Extended Rapid Viral Response (eRVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12
timeFrame: Week 4 and Week 12
measure: Number of Subjects With Undetectable HCV RNA at Week 12
timeFrame: Week 12
measure: Number of Subjects With Undetectable HCV RNA at End of Treatment (EOT)
timeFrame: End of treatment (up to Week 48)
measure: Number of Subjects With Undetectable HCV RNA 12 Weeks After Last Planned Dose of Study Treatment
timeFrame: 12 weeks after last planned dose of study treatment (up to Week 60)
measure: Number of Subjects With Undetectable HCV RNA 24 Weeks After Last Actual Dose of Study Treatment
timeFrame: 24 weeks after last actual dose of study treatment (up to Week 72)
measure: Number of Subjects With Viral Relapse Planned and Viral Relapse Actual
timeFrame: After last dose of study drug up to 24 week antiviral follow-up (up to Week 72)
measure: Biochemical Response: Number of Subjects With Grade 3 and 4 Shifts From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Levels
timeFrame: Baseline up to Week 48
measure: Noninvasive Markers of Fibrosis: Number of Subjects With Improvement in FibroTest Analysis
timeFrame: Baseline through 24 weeks after last planned dose of study treatment (up to Week 72)
measure: Fatigue Severity Scale (FSS) Total Score
timeFrame: Baseline, Week 4, 12, 24, 36, 48, 72
measure: Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to Week 48
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Fresno
country: United States
state: California
city: LaJolla
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: San Francisco
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Gainesville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: South Miami
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Savannah
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Chicago
country: United States
state: Illinois
city: Carmel
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Portland
country: United States
state: Maine
city: Baltimore
country: United States
state: Maryland
city: Laurel
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Worcester
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Kansas City
country: United States
state: Missouri
city: St Louis
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Albuquerque
country: United States
state: New Mexico
city: Manhasset
country: United States
state: New York
city: New York City
country: United States
state: New York
city: New York City
country: United States
state: New York
city: New York City
country: United States
state: New York
city: New York City
country: United States
state: New York
city: Valhalla
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Fayetteville
country: United States
state: North Carolina
city: Cincinatti
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Hershey
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Germantown
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Annandale
country: United States
state: Virginia
city: Charlottesville
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Buenos Aires
country: Argentina
city: Darlinghurst
country: Australia
city: Fitzroy
country: Australia
city: Greenslopes
country: Australia
city: Melbourne
country: Australia
city: Perth
country: Australia
city: Westmead
country: Australia
city: Woolloongabba
country: Australia
city: Linz
country: Austria
city: Vienna
country: Austria
city: Calgary
country: Canada
city: Toronto
country: Canada
city: Vancouver
country: Canada
city: Winnipeg
country: Canada
city: Clichy
country: France
city: Creteil
country: France
city: Grenoble
country: France
city: Lyon
country: France
city: Nice
country: France
city: Paris
country: France
city: Pessac
country: France
city: Toulouse
country: France
city: Berlin
country: Germany
city: Bochum
country: Germany
city: Dusseldorf
country: Germany
city: Frankfurt
country: Germany
city: Freiburg
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Koln
country: Germany
city: Muenchen
country: Germany
city: Haifa
country: Israel
city: Jerusalem
country: Israel
city: Nazareth
country: Israel
city: Petah Tikva
country: Israel
city: Tel Hashomer
country: Israel
city: Bologna
country: Italy
city: Milano
country: Italy
city: Torino
country: Italy
city: Bialystok
country: Poland
city: Czeladz
country: Poland
city: Kielce
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Wroclaw
country: Poland
city: Santurce
country: Puerto Rico
city: Barcelona
country: Spain
city: Valencia
country: Spain
city: Glasgow
country: United Kingdom
city: Hampstead
country: United Kingdom
city: London
country: United Kingdom
Study officials:
affiliation: Vertex Pharmaceuticals Incorporated
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Jacobson IM, McHutchison JG, Dusheiko G, Di Bisceglie AM, Reddy KR, Bzowej NH, Marcellin P, Muir AJ, Ferenci P, Flisiak R, George J, Rizzetto M, Shouval D, Sola R, Terg RA, Yoshida EM, Adda N, Bengtsson L, Sankoh AJ, Kieffer TL, George S, Kauffman RS, Zeuzem S; ADVANCE Study Team. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med. 2011 Jun 23;364(25):2405-16. doi: 10.1056/NEJMoa1012912.