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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00627926




Registration number
NCT00627926
Ethics application status
Date submitted
22/02/2008
Date registered
4/03/2008
Date last updated
8/08/2014

Titles & IDs
Public title
A Phase 3 Study of Telaprevir in Combination With Pegasys® and Copegus® in Treatment-Naive Subjects With Genotype 1 Hepatitis C Virus (HCV)
Scientific 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
Secondary ID [1] 0 0
VX07-950-108
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Pegylated Interferon Alfa 2a
Treatment: Drugs - Telaprevir
Treatment: Drugs - Ribavirin
Other interventions - Placebo

Placebo comparator: PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week - Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 48 weeks.

Experimental: Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week - Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.

Experimental: Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week - Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.


Treatment: Other: Pegylated Interferon Alfa 2a
subcutaneous injection, 180 micrograms once per week

Treatment: Drugs: Telaprevir
375 mg tablets administered orally every 8 hours at a dose of 750 mg

Treatment: Drugs: Ribavirin
200 mg tablets administered orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing =75 kg

Other interventions: Placebo
Telaprevir matching placebo
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Intervention code [3] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
24 weeks after last planned dose of study treatment (up to Week 72)
Secondary outcome [1] 0 0
Number of Subjects With Undetectable HCV RNA at Week 72
Timepoint [1] 0 0
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)
Secondary outcome [2] 0 0
Number of Subjects Achieving Rapid Viral Response (RVR), Demonstrated by Achieving Undetectable HCV RNA 4 Weeks After Starting Study Treatment
Timepoint [2] 0 0
Week 4
Secondary outcome [3] 0 0
Number of Subjects Achieving Extended Rapid Viral Response (eRVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12
Timepoint [3] 0 0
Week 4 and Week 12
Secondary outcome [4] 0 0
Number of Subjects With Undetectable HCV RNA at Week 12
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Number of Subjects With Undetectable HCV RNA at End of Treatment (EOT)
Timepoint [5] 0 0
End of treatment (up to Week 48)
Secondary outcome [6] 0 0
Number of Subjects With Undetectable HCV RNA 12 Weeks After Last Planned Dose of Study Treatment
Timepoint [6] 0 0
12 weeks after last planned dose of study treatment (up to Week 60)
Secondary outcome [7] 0 0
Number of Subjects With Undetectable HCV RNA 24 Weeks After Last Actual Dose of Study Treatment
Timepoint [7] 0 0
24 weeks after last actual dose of study treatment (up to Week 72)
Secondary outcome [8] 0 0
Number of Subjects With Viral Relapse Planned and Viral Relapse Actual
Timepoint [8] 0 0
After last dose of study drug up to 24 week antiviral follow-up (up to Week 72)
Secondary outcome [9] 0 0
Biochemical Response: Number of Subjects With Grade 3 and 4 Shifts From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Levels
Timepoint [9] 0 0
Baseline up to Week 48
Secondary outcome [10] 0 0
Noninvasive Markers of Fibrosis: Number of Subjects With Improvement in FibroTest Analysis
Timepoint [10] 0 0
Baseline through 24 weeks after last planned dose of study treatment (up to Week 72)
Secondary outcome [11] 0 0
Fatigue Severity Scale (FSS) Total Score
Timepoint [11] 0 0
Baseline, Week 4, 12, 24, 36, 48, 72
Secondary outcome [12] 0 0
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [12] 0 0
Baseline up to Week 48

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2010
Sample size
Target
Accrual to date
Final
1095
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Darlinghurst
Recruitment hospital [2] 0 0
- Fitzroy
Recruitment hospital [3] 0 0
- Greenslopes
Recruitment hospital [4] 0 0
- Melbourne
Recruitment hospital [5] 0 0
- Perth
Recruitment hospital [6] 0 0
- Westmead
Recruitment hospital [7] 0 0
- Woolloongabba
Recruitment postcode(s) [1] 0 0
- Darlinghurst
Recruitment postcode(s) [2] 0 0
- Fitzroy
Recruitment postcode(s) [3] 0 0
- Greenslopes
Recruitment postcode(s) [4] 0 0
- Melbourne
Recruitment postcode(s) [5] 0 0
- Perth
Recruitment postcode(s) [6] 0 0
- Westmead
Recruitment postcode(s) [7] 0 0
- Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Hawaii
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maine
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
Nebraska
Country [16] 0 0
United States of America
State/province [16] 0 0
New Mexico
Country [17] 0 0
United States of America
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New York
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North Carolina
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Ohio
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Virginia
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Argentina
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Buenos Aires
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Austria
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Linz
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Austria
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Vienna
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Canada
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Calgary
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Canada
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Toronto
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Canada
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Vancouver
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Canada
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Winnipeg
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France
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Clichy
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France
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Creteil
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France
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Grenoble
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France
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Lyon
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France
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Nice
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France
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Paris
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France
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Pessac
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France
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Toulouse
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Germany
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Berlin
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Germany
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Bochum
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Germany
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Dusseldorf
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Germany
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Frankfurt
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Germany
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Freiburg
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Germany
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Hamburg
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Germany
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Hannover
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Germany
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Koln
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Germany
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Muenchen
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Nazareth
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Israel
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Petah Tikva
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Israel
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Tel Hashomer
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Italy
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Bologna
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Italy
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Milano
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Italy
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Torino
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Poland
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Bialystok
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Czeladz
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Kielce
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Krakow
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Lodz
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Wroclaw
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Puerto Rico
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Santurce
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Spain
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Barcelona
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Spain
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Valencia
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United Kingdom
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Glasgow
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United Kingdom
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Hampstead
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United Kingdom
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Vertex Pharmaceuticals Incorporated
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Tibotec Pharmaceutical Limited
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Monitor
Address 0 0
Vertex Pharmaceuticals Incorporated
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00627926