VX-950-TiDP24-C219: A Roll Over Trial for Patients in the Control Group of the C216 Study Who Received Telaprevir Placebo
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
3 other identifiers
interventional
90
15 countries
48
Brief Summary
The purpose of this study is to provide access to telaprevir for patients from the control group in the C216 study, who failed treatment for virologic reasons. Efficacy, safety and tolerability of telaprevir in combination with standard treatment will be evaluated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2010
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2010
CompletedFirst Posted
Study publicly available on registry
January 22, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedResults Posted
Study results publicly available
April 19, 2013
CompletedMay 8, 2013
May 1, 2013
1.9 years
January 21, 2010
March 8, 2013
May 6, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Percentage of Participants Achieving a Sustained Virologic Response (SVR) 24 Weeks After the Last Dose of Study Drug (SVR24 Actual)
The table below shows the percentage of participants acheiving a SVR 24 weeks after the last dose of study drug defined as having plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels \< 25 IU/mL, target not detected at end of treatment (EOT) AND the participant did not relapse AND the participant completed the treatment; OR if the participant had plasma HCV RNA levels of \< 25 IU/mL, target not detected at EOT AND the participant did not relapse AND the participant prematurely discontinued at least one study medication, but never for the reason virologic failure.
End of trial (24 weeks after last dose, administerd at 48 weeks)
Secondary Outcomes (9)
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
Baseline, Weeks 4, 8, 12, 24, 36, and 48, and at the end of treatment (Week 48 or at time of early discontinuation)
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
Week 4, Week 8
Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue All Study Drugs at Week 12, 24, or 36
Week 12 or Weeks 24 or 36
Percentage of Participants Achieving Rapid Virologic Response (RVR)
Week 4
Percentage of Participants Achieving Extended Rapid Virologic Response (eRVR)
Weeks 4 and 12
- +4 more secondary outcomes
Study Arms (1)
Telaprevir + Standard Treatment
EXPERIMENTALTelaprevir 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.
Interventions
180 microgram (mcg) by subcutaneous injection once weekly for 48 weeks.
1,000 or 1,200 mg/day (weight based) orally twice daily for 48 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
Unknown Facility
Coronado, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
San Francisco, California, United States
Unknown Facility
Bradenton, Florida, United States
Unknown Facility
Miami, Florida, United States
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Atlanta, Georgia, United States
Unknown Facility
Indianapolis, Indiana, United States
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Kansas City, Missouri, United States
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New York, New York, United States
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Chapel Hill, North Carolina, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
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Columbia, South Carolina, United States
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Houston, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Adelaide, Australia
Unknown Facility
Clayton, Australia
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Darlinghurst, Australia
Unknown Facility
Perth, Australia
Unknown Facility
Brussels, Belgium
Unknown Facility
Ghent, Belgium
Unknown Facility
Leuven, Belgium
Unknown Facility
Distrito Barao Geraldo-Campina, Brazil
Unknown Facility
Salvador, Brazil
Unknown Facility
São Paulo, Brazil
Unknown Facility
Montreal, Quebec, Canada
Unknown Facility
Clichy, France
Unknown Facility
Créteil, France
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Lille, France
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Pessac, France
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Berlin, Germany
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Cologne, Germany
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Frankfurt, Germany
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Hamburg, Germany
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Hanover, Germany
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München, Germany
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Petah Tikva, Israel
Unknown Facility
Safed, Israel
Unknown Facility
Amsterdam, Netherlands
Unknown Facility
Nijmegen, Netherlands
Unknown Facility
Bialystok, Poland
Unknown Facility
Czeladź, Poland
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Warsaw, Poland
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San Juan, Puerto Rico
Unknown Facility
Barcelona, Spain
Unknown Facility
Valencia, Spain
Unknown Facility
Stockholm, Sweden
Unknown Facility
Zurich, Switzerland
Unknown Facility
London, United Kingdom
Related Publications (1)
Susser S, Flinders M, Reesink HW, Zeuzem S, Lawyer G, Ghys A, Van Eygen V, Witek J, De Meyer S, Sarrazin C. Evolution of hepatitis C virus quasispecies during repeated treatment with the NS3/4A protease inhibitor telaprevir. Antimicrob Agents Chemother. 2015 May;59(5):2746-55. doi: 10.1128/AAC.04911-14. Epub 2015 Feb 23.
PMID: 25712364DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Leader
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Infectious Diseases BVBA Clinical Trial
Janssen Infectious Diseases BVBA
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2010
First Posted
January 22, 2010
Study Start
April 1, 2010
Primary Completion
March 1, 2012
Study Completion
May 1, 2012
Last Updated
May 8, 2013
Results First Posted
April 19, 2013
Record last verified: 2013-05