A Phase 2a Study to Evaluate Viral Kinetics and Safety of Telaprevir in Participants With Genotype 2 or 3 Hepatitis C Infection
A Phase IIa Randomized, Partially Blinded Trial of Telaprevir (VX-950) in Treatment-Naive Subjects With Chronic Genotype 2 or 3 Hepatitis C Infection
2 other identifiers
interventional
52
3 countries
7
Brief Summary
The purpose of this study is to assess the effect of telaprevir on early hepatitis (inflammation of the liver) C virus (HCV) viral kinetics in treatment-naive participants who are chronically (lasting a long time) infected with genotype 2 or 3 HCV.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2007
Shorter than P25 for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2007
CompletedFirst Posted
Study publicly available on registry
November 20, 2007
CompletedStudy Start
First participant enrolled
December 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedResults Posted
Study results publicly available
June 4, 2013
CompletedJune 17, 2013
June 1, 2013
6 months
November 19, 2007
March 8, 2013
June 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Day 15
Level of HCV RNA in plasma was measured using COBAS TaqMan HCV test v2.0 (an in vitro nucleic acid amplification test for quantitation of HCV RNA genotypes 1 through 6 in human serum or plasma, using the COBAS AmpliPrep Total Nucleic Acid Isolation Kit (TNAI) for preparation of highly purified total nucleic acid from serum or plasma and automated amplification and detection on TaqMan 48 Analyzer). Lower limit of quantification was 25 international units/milliliter (IU/ml) and limit of detection was 10 IU/ml. Assay used was reverse transcription-polymerase chain reaction (RT-PCR) methodology.
Baseline, Pre-dose (Day 15)
Maximum Plasma Concentration (Cmax) for Telaprevir on Day 1
The Cmax is defined as the maximum observed analyte concentration. The Cmax was measured in nanogram/milliliter (ng/ml).
Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hour [hr])
Time to Reach Maximum Plasma Concentration (Tmax) for Telaprevir on Day 1
The Tmax is defined as the actual sampling time to reach maximum observed analyte concentration. The analyte concentration associated with Tmax is referred to as Cmax.
Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hr)
Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 1
The AUC is defined as area under the plasma concentration-time curve over the dosing interval (8 hr), calculated by the lin-up/ log-down method.
Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hr)
Secondary Outcomes (9)
Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 15
Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr)
Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Week 24 and Week 26
Baseline and Week 24/26
Maximum Plasma Concentration (Cmax) for Telaprevir on Day 15
Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr)
Minimum Plasma Concentration (Cmin) for Telaprevir on Day 15
Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr)
Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml)
Baseline, Day 12, 15, Week 4, 6, 14 and EOT (Week 24/26 or early discontinuation)
- +4 more secondary outcomes
Study Arms (6)
TVR then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2
EXPERIMENTALParticipants who are never treated for chronic hepatitis C (inflammation of the liver) genotype 2 will receive telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants will then be treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of pegylated interferon 180 microgram (mcg) will be administered as a subcutaneous injection once a week. RBV will be taken orally as 400 mg tablets 2 times a day. Total duration of treatment will be 26 weeks.
TVR with Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2
EXPERIMENTALParticipants who are never treated for CHC genotype 2 will receive TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which will be continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg will be administered as a subcutaneous injection once a week. RBV will be taken orally as 400 mg tablets 2 times a day. Total duration of treatment will be 24 weeks.
Pbo with Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2
ACTIVE COMPARATORParticipants who are never treated for CHC genotype 2 will receive TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which will be continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg will be administered as a subcutaneous injection once a week. RBV will be taken orally as 400 mg tablets 2 times a day. Total duration of treatment will be 24 weeks.
TVR then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3
EXPERIMENTALParticipants who are never treated for CHC genotype 3 will receive TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants will then be treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg will be administered as a subcutaneous injection once a week. RBV will be taken orally as 400 mg tablets 2 times a day. Total duration of treatment will be 26 weeks.
TVR with Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3
EXPERIMENTALParticipants who are never treated for CHC genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which will be continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg will be administered as a subcutaneous injection once a week. RBV will be taken orally as 400 mg tablets 2 times a day. Total duration of treatment will be 24 weeks.
Pbo with Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3
ACTIVE COMPARATORParticipants who are never treated for CHC genotype 3 will receive TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which will be continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg will be administered as a subcutaneous injection once a week. RBV will be taken orally as 400 mg tablets 2 times a day. Total duration of treatment will be 24 weeks.
Interventions
Telaprevir 750 mg tablet will be administered three times a day orally for 2 weeks.
Standard treatment of Peg-IFN-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (400 mg as oral tablet twice daily) will be administered from Day 15 to Week 24 or 26 in the T2 \& PR24 - genotype 2 and 3 group and from Day 1 to Week 24 or 26 in the T2/PR24 - genotype 2 and 3 group.
Matching placebo tablet to telaprevir will be administered three times a day orally for 2 weeks.
Eligibility Criteria
You may qualify if:
- Participants chronically infected with genotype 2 or 3 hepatitis C virus (HCV) with amount of virus in the blood greater than 10,000 international units per milliliter (IU/ml)
- Participants who were never treated for hepatitis C virus infection
- Participants without any significant lab abnormalities
- Participants who agree to the use of two effective methods of contraception
- Participant who were judged to be in good health
You may not qualify if:
- Participants who had contraindications for starting anti-HCV therapy
- Participants who had history or evidence of liver cirrhosis (serious liver disorder in which connective tissue replaces normal liver tissue, and liver failure often occurs) or decompensated liver disease or hepatocellular carcinoma (type of cancer)
- Participant infected with human immunodeficiency virus (a life-threatening infection that you can get from an infected person's blood or from having sex with an infected person) or hepatitis B virus
- Females who are pregnant (carrying an unborn baby), planning to be pregnant or breastfeeding
- Participants who have hypersensitivity to tartrazine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tibotec BVBAlead
Study Sites (7)
Unknown Facility
Clichy, France
Unknown Facility
Créteil, France
Unknown Facility
Lyon, France
Unknown Facility
Paris, France
Unknown Facility
Vandœuvre-lès-Nancy, France
Unknown Facility
Stockholm, Sweden
Unknown Facility
London, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Leader
- Organization
- Janssen Research & Development, LLC
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
November 19, 2007
First Posted
November 20, 2007
Study Start
December 1, 2007
Primary Completion
June 1, 2008
Study Completion
May 1, 2009
Last Updated
June 17, 2013
Results First Posted
June 4, 2013
Record last verified: 2013-06