An Exploratory Study of Telaprevir in Treatment-Naive Participants With Chronic Genotype 4 Hepatitis C Virus Infection
A Phase IIa Randomized, Partially Blinded Trial of Telaprevir (VX-950) in Treatment-Naive Subjects With Chronic Genotype 4 Hepatitis C Infection
2 other identifiers
interventional
24
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the activity and safety of telaprevir on Hepatitis C Virus (HCV) Genotype 4, alone or in combination with standard therapy, that is, pegylated-interferon-alfa-2a and ribavirin in treatment-naive (never been treated before with antiretroviral therapy) participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2008
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
December 20, 2007
CompletedFirst Posted
Study publicly available on registry
December 27, 2007
CompletedStudy Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedResults Posted
Study results publicly available
July 12, 2013
CompletedSeptember 9, 2013
August 1, 2013
2 years
December 20, 2007
March 7, 2013
August 27, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Day 15
The plasma HCV RNA levels were used to assess the antiviral activity which included viral response as either undetectable HCV RNA (that is no HCV target was detected in the plasma sample) or less than 25 International unit per milliliter (IU/mL) of HCV RNA (that is Plasma sample contained HCV RNA at a concentration below the limit of quantification \[LLOQ=25 IU/mL\] of the viral load assay). Plasma HCV RNA levels were measured using the COBAS TaqMan HCV test Version 2.0. This assay used real-time reverse transcription-polymerase chain reaction (RT-PCR) methodology.
Baseline and Day 15
Secondary Outcomes (11)
Percentage of Participants With Viral Response (Undetectable HCV RNA)
Day 15 up to EOT (Week 48/50 or early discontinuation)
Median Time to First Viral Response (Undetectable HCV RNA)
Up to Week 48/50
Number of Participants With Viral Breakthrough (Detectable HCV RNA)
Day 8, Day 12, Day 15, Week 24/26 and Week 36/38
Percentage of Participants With Sustained Viral Response (SVR)
Week 12 and 24 after the last dose of study medication
Percentage of Participants With Relapse
Week 24 after EOT (Week 48/50 or early discontinuation)
- +6 more secondary outcomes
Study Arms (3)
Telaprevir and then Pegylated-interferon-alfa-2a+Ribavirin
EXPERIMENTALTelaprevir 750 milligram (mg) tablet will be administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram \[mcg\] subcutaneous injection \[injected under the skin by way of a needle\], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) will be administered from Week 2 to 50.
Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin
EXPERIMENTALTelaprevir 750 mg tablet will be administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily), from Week 1 to 48.
Placebo+Pegylated-interferon-alfa-2a+Ribavirin
ACTIVE COMPARATORMatching placebo tablet to telaprevir will be administered three times a day orally for 2 weeks along with pegylated-interferon-alfa 2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily), from Week 1 to 48.
Interventions
Telaprevir 750 milligram (mg) tablet will be administered three times a day orally for 2 weeks.
Pegylated-interferon-alfa-2a (180 microgram \[mcg\] subcutaneous injection, once weekly) will be administered from Week 1 to Week 48 or 50.
Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks.
Ribavirin (1000-1200 mg as oral tablet daily) will be administered from Week 1 to Week 48 or 50.
Eligibility Criteria
You may qualify if:
- Plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level greater than 10,000 International unit per milliliter (IU/mL) at Screening
- Participant never received treatment for HCV
- Participant was to be in good health (besides HCV infection), in the opinion of the Investigator, judged on the basis of medical history and physical examination (including vital signs and screening electrocardiogram \[ECG\]), with any chronic medical conditions under stable medical control
You may not qualify if:
- Participant has human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection
- Female participants who are pregnant, or planning to become pregnant, or breastfeeding, and partners of female participants who are pregnant or breastfeeding
- Participant has hypersensitivity to tartrazine
- Participant had participated in any clinical trial for an investigational drug within 90 days before drug administration or participated in more than 2 drug studies in the last 12 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tibotec BVBAlead
Related Publications (1)
De Meyer S, Ghys A, Dierynck I, Beumont M, Luo D, Picchio G. Virologic characterization of genotype 4 hepatitis C virus variants in patients treated with telaprevir. Virol J. 2014 May 16;11:93. doi: 10.1186/1743-422X-11-93.
PMID: 24886541DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Leader
- Organization
- Janssen Research & Development, LLC, Titusville, NJ
Study Officials
- STUDY DIRECTOR
Tibotec-Virco Virology BVBA Clinical Trial
Tibotec BVBA
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2007
First Posted
December 27, 2007
Study Start
January 1, 2008
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
September 9, 2013
Results First Posted
July 12, 2013
Record last verified: 2013-08