Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01054573




Registration number
NCT01054573
Ethics application status
Date submitted
21/01/2010
Date registered
22/01/2010
Date last updated
8/05/2013

Titles & IDs
Public title
VX-950-TiDP24-C219: A Roll Over Trial for Patients in the Control Group of the C216 Study Who Received Telaprevir Placebo
Scientific title
An Open-label, Single-arm, Roll-over Trial of Telaprevir in Combination With Pegylated Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) for Subjects From the Control Group of the VX- 950-TiDP24-C216 Trial Who Failed Therapy for Virologic Reasons
Secondary ID [1] 0 0
VX-TiDP24-C219
Secondary ID [2] 0 0
CR016678
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 - pegylated interferon (Peg-IFN) alfa-2a
Treatment: Drugs - ribavirin (RBV)

Experimental: Telaprevir + Standard Treatment - Telaprevir 750 mg orally (by mouth) every 8h for 12 weeks plus standard treatment. Standard treatment is 180 mcg subcutaneous (under the skin) injection pegylated interferon (Peg-IFN) alfa-2a and 1000-1200 mg twice daily ribavirin (RBV) for 48 weeks.


Treatment: Drugs: Telaprevir
750 mg orally every 8 hours (q8h) for 12 weeks

Treatment: Drugs: pegylated interferon (Peg-IFN) alfa-2a
180 microgram (mcg) by subcutaneous injection once weekly for 48 weeks.

Treatment: Drugs: ribavirin (RBV)
1,000 or 1,200 mg/day (weight based) orally twice daily for 48 weeks.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Percentage of Participants Achieving a Sustained Virologic Response (SVR) 24 Weeks After the Last Dose of Study Drug (SVR24 Actual)
Timepoint [1] 0 0
End of trial (24 weeks after last dose, administerd at 48 weeks)
Secondary outcome [1] 0 0
The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points
Timepoint [1] 0 0
Baseline, Weeks 4, 8, 12, 24, 36, and 48, and at the end of treatment (Week 48 or at time of early discontinuation)
Secondary outcome [2] 0 0
Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue Telaprevir and Continue Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) at Week 4 or Week 8
Timepoint [2] 0 0
Week 4, Week 8
Secondary outcome [3] 0 0
Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue All Study Drugs at Week 12, 24, or 36
Timepoint [3] 0 0
Week 12 or Weeks 24 or 36
Secondary outcome [4] 0 0
Percentage of Participants Achieving Rapid Virologic Response (RVR)
Timepoint [4] 0 0
Week 4
Secondary outcome [5] 0 0
Percentage of Participants Achieving Extended Rapid Virologic Response (eRVR)
Timepoint [5] 0 0
Weeks 4 and 12
Secondary outcome [6] 0 0
Percentage of Participants With Viral Breakthrough
Timepoint [6] 0 0
Week 48 (Period After Telaprevir Intake) and Week 12 (Telaprevir Treatment Phase)
Secondary outcome [7] 0 0
Percentage of Participants Who Relapsed During Follow-Up
Timepoint [7] 0 0
During Follow-Up (24 weeks after the last dose of study drug, administerd at 48 weeks)
Secondary outcome [8] 0 0
Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time
Timepoint [8] 0 0
Baseline, Weeks 4, 8, 12, 24, 36, 48
Secondary outcome [9] 0 0
Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level
Timepoint [9] 0 0
Baseline, Weeks 4, 8, 12, 24, 36, and 48

Eligibility
Key inclusion criteria
* Patient from the control group of the C216 study who failed therapy for virologic reasons
* Patient must have completed all assessments in the C216 trial
* 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 received any direct acting anti-viral HCV therapy after discontinuation of the C216 trial
* Patient has history of decompensated liver disease
* Patient has history of acute or chronic pancreatitis
* Patient has condition that requires use of systemic corticosteroids
* Patient who prematurely stopped medication for non-compliance or for whom it would be unsafe to repeat treatment
* Patient has history of decompensated liver disease or history of cirrhosis with hepatocellular carcinoma

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
1/04/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2012
Sample size
Target
Accrual to date
Final
90
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Clayton
Recruitment hospital [3] 0 0
- Darlinghurst
Recruitment hospital [4] 0 0
- Perth
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Clayton
Recruitment postcode(s) [3] 0 0
- Darlinghurst
Recruitment postcode(s) [4] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
South Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
Belgium
State/province [11] 0 0
Brussels
Country [12] 0 0
Belgium
State/province [12] 0 0
Gent
Country [13] 0 0
Belgium
State/province [13] 0 0
Leuven
Country [14] 0 0
Brazil
State/province [14] 0 0
Distrito Barao Geraldo-Campina
Country [15] 0 0
Brazil
State/province [15] 0 0
Salvador
Country [16] 0 0
Brazil
State/province [16] 0 0
Sao Paulo
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
France
State/province [18] 0 0
Clichy
Country [19] 0 0
France
State/province [19] 0 0
Créteil
Country [20] 0 0
France
State/province [20] 0 0
Lille Cedex
Country [21] 0 0
France
State/province [21] 0 0
Pessac
Country [22] 0 0
Germany
State/province [22] 0 0
Berlin
Country [23] 0 0
Germany
State/province [23] 0 0
Frankfurt
Country [24] 0 0
Germany
State/province [24] 0 0
Hamburg
Country [25] 0 0
Germany
State/province [25] 0 0
Hannover
Country [26] 0 0
Germany
State/province [26] 0 0
Köln
Country [27] 0 0
Germany
State/province [27] 0 0
München
Country [28] 0 0
Israel
State/province [28] 0 0
Petah Tiqva
Country [29] 0 0
Israel
State/province [29] 0 0
Zefat
Country [30] 0 0
Netherlands
State/province [30] 0 0
Amsterdam
Country [31] 0 0
Netherlands
State/province [31] 0 0
Nijmegen
Country [32] 0 0
Poland
State/province [32] 0 0
Bialystok
Country [33] 0 0
Poland
State/province [33] 0 0
Czeladz
Country [34] 0 0
Poland
State/province [34] 0 0
Warszawa
Country [35] 0 0
Puerto Rico
State/province [35] 0 0
San Juan
Country [36] 0 0
Spain
State/province [36] 0 0
Barcelona
Country [37] 0 0
Spain
State/province [37] 0 0
Valencia
Country [38] 0 0
Sweden
State/province [38] 0 0
Stockholm
Country [39] 0 0
Switzerland
State/province [39] 0 0
Zurich N/A
Country [40] 0 0
United Kingdom
State/province [40] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Infectious Diseases BVBA
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Vertex Pharmaceuticals Incorporated
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
Janssen Infectious Diseases BVBA Clinical Trial
Address 0 0
Janssen Infectious Diseases 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

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/NCT01054573