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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00703118




Registration number
NCT00703118
Ethics application status
Date submitted
19/06/2008
Date registered
23/06/2008
Date last updated
22/01/2014

Titles & IDs
Public title
A Safety and Effectiveness Study of Telaprevir in Chronic, Genotype 1, Hepatitis C Patients That Failed Previous Standard Treatment
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Phase III Trial of 2 Regimens of Telaprevir (With and Without Delayed Start) Combined With Pegylated Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Subjects With Chronic, Genotype 1, Hepatitis C Infection Who Failed Prior Standard Treatment
Secondary ID [1] 0 0
VX-950-TIDP24-C216
Secondary ID [2] 0 0
CR014842
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C, Chronic 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: Drugs - Telaprevir
Treatment: Drugs - Peg-IFN-alfa-2a
Treatment: Drugs - Ribavirin
Treatment: Drugs - Placebo

Experimental: Group A: T12/PR48 - Participants will receive 12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses.

Experimental: Group B: T12(DS)/PR48 - Participants will receive 4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses.

Experimental: Group C: Pbo/PR48 - Participants will receive placebo in combination with Peg- IFN-alfa-2a and ribavirin for 16 weeks. Participants will receive Peg- IFN-alfa-2a and ribavirin for next 32 weeks.


Treatment: Drugs: Telaprevir
Participants will receive telaprevir tablets of 750 mg orally eight hourly for 12 weeks in group A and B.

Treatment: Drugs: Peg-IFN-alfa-2a
Participants will receive 180 µg subcutaneous (under the skin) injection of Peg-IFN-alfa-2a once weekly for 48 weeks in Group A, B and C.

Treatment: Drugs: Ribavirin
Participants will receive ribavirin tablets of 1000-1200 mg orally twice daily for 48 weeks in Group A, B, and C.

Treatment: Drugs: Placebo
Participants will receive telaprevir matching placebo tablets orally for 4 weeks in Group A and B. Participants will receive telaprevir matching placebo tablets orally for 16 weeks in Group C.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned
Timepoint [1] 0 0
Week 72
Secondary outcome [1] 0 0
Number of Participants Acheiving Rapid Virologic Response (RVR) at Week 4
Timepoint [1] 0 0
Week 4
Secondary outcome [2] 0 0
Number of Participants Acheiving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 48 (End of Treatment)
Timepoint [2] 0 0
Week 48
Secondary outcome [3] 0 0
Number of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Medication - SVR12 Planned
Timepoint [3] 0 0
Week 60
Secondary outcome [4] 0 0
Number of Participants Who Meet the Telaprevir Stopping Rule at Week 4, Week 6, or Week 8
Timepoint [4] 0 0
Week 4, Week 6, or Week 8
Secondary outcome [5] 0 0
Number of Participants Who Have Viral Relapse During Entire Follow-up Period (up to Week 72)
Timepoint [5] 0 0
Up to Week 72
Secondary outcome [6] 0 0
Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4
Timepoint [6] 0 0
Baseline (Day 1) to Week 4
Secondary outcome [7] 0 0
Number of Participants Acheiving Extended Rapid Virologic Response at Week 4 and Week 12
Timepoint [7] 0 0
Week 4 and Week 12

Eligibility
Key inclusion criteria
- Patient must have chronic hepatitis C infection (genotype 1) with HCV RNA level >=
1000 IU/mL

- Patient must have failed at least 1 prior course of Peg-IFN/RBV therapy (standard
treatment)

- Patient must be willing to use 2 effective methods of birth control for up to 7 months
after last dose of study medication
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patient is a previous non-responder that is classified as a viral breakthrough case

- Patient is infected with Hepatitis C virus, genotype 1, exhibiting more than one
subtype

- Patient has Hepatitis C virus, genotype 1, and exhibits co-infection with any other
genotype

- Evidence of decompensated liver disease

- Patient has condition that requires use of systemic corticosteroids

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
1/10/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2010
Sample size
Target
Accrual to date
Final
663
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Camperdown
Recruitment hospital [3] 0 0
- Clayton
Recruitment hospital [4] 0 0
- Darlinghurst
Recruitment hospital [5] 0 0
- Kingswood
Recruitment hospital [6] 0 0
- Melbourne
Recruitment hospital [7] 0 0
- Parkville - Vic
Recruitment hospital [8] 0 0
- Perth
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Camperdown
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- Clayton
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- Darlinghurst
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- Kingswood
Recruitment postcode(s) [6] 0 0
- Melbourne
Recruitment postcode(s) [7] 0 0
- Parkville - Vic
Recruitment postcode(s) [8] 0 0
- Perth
Recruitment outside Australia
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United States of America
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Alabama
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California
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Indiana
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Maryland
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Massachusetts
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Michigan
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Missouri
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North Carolina
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Pennsylvania
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South Carolina
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Texas
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Virginia
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Austria
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Graz N/A
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Austria
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Wien
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Belgium
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Brussels
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Belgium
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Bruxelles
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Gent
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Leuven
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Distrito Barao Geraldo-Campina
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Salvador
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Santo Andre
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Sao Paulo
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Ontario
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France
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Vandoeuvre Les Nancy
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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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München
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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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Petah Tiqva
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Israel
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Tel-Aviv
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Israel
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Zefat
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Netherlands
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Leiden
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Netherlands
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Nijmegen
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Bialystok
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Czeladz
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Kielce
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Lodz
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Warszawa
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Puerto Rico
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Santurce
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Barcelona
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Madrid
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Sevilla N/A
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Spain
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Valencia
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Sweden
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Stockholm
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Switzerland
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St Gallen
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Switzerland
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Zurich N/A
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United Kingdom
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Birmingham
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United Kingdom
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Tibotec BVBA
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
The purpose of this study is to determine the safety, efficacy and tolerability of using two
regimens of telaprevir (with and without delayed start) with standard treatment compared to
standard treatment alone in participants with chronic, genotype 1, hepatitis C.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00703118
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tibotec-Virco Virology BVBA Clinical Trial
Address 0 0
Tibotec BVBA
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00703118