Hepatitis C, ChronicPhase 2NCT00561015
A Phase 2a Study to Evaluate Viral Kinetics and Safety of Telaprevir in Participants With Genotype 2 or 3 Hepatitis C Infection
A Phase 2 study testing Telaprevir and Peg-IFN-alfa-2a + Ribavirin (Standard Treatment) in people with Hepatitis C, Chronic, run by Tibotec BVBA at 7 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- Telaprevir and Peg-IFN-alfa-2a + Ribavirin (Standard Treatment)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Dec 2007to May 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
France5 sites
Study site
Clichy
Study site
Créteil
Study site
Lyon
Study site
Paris
Study site
Vandœuvre-lès-Nancy
About this study
Official title: A Phase IIa Randomized, Partially Blinded Trial of Telaprevir (VX-950) in Treatment-Naive Subjects With Chronic Genotype 2 or 3 Hepatitis C Infection
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.
Read the detailed description
This is a Phase 2a multicenter (when more than one hospital or medical school team work on a medical research study), partially blinded, randomized (study drug assigned by chance) stratified (arrange in groups for analysis of results e.g., stratify by age, sex, etc.) for genotype, multiple dose study. The trial will consist of Screening period (6 weeks), Treatment period (24 or 26 weeks) and Follow-up period (24 weeks). The Treatment period will include 2 weeks investigational treatment phase and a 24 week standard treatment phase. All the eligible participants who were never treated for HCV will be enrolled for the trial and will receive the investigational treatment regimen to which they have been randomly assigned for 2 weeks. After this in the standard treatment phase participants will receive the standard treatment of care consisting of pegylated interferon (Peg-IFN)-alfa-2a 180 microgram once weekly and ribavirin (RBV) 400 milligram twice per day. Efficacy will primarily be evaluated by HCV viral load quantification. Participant's safety will be monitored throughout the study.
- Conditions
- Hepatitis C, Chronic
- Being tested
- Telaprevir, Peg-IFN-alfa-2a + Ribavirin (Standard Treatment), Placebo
- Keywords
- Hepatitis C, Chronic, Genotype 2, Genotype 3, Telaprevir
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelaprevirDrug
Also called VX-950
Telaprevir 750 mg tablet will be administered three times a day orally for 2 weeks.
Peg-IFN-alfa-2a + Ribavirin (Standard Treatment)Drug
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.
PlaceboDrug
Matching placebo tablet to telaprevir will be administered three times a day orally for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| TVR then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | Experimental | Participants 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. Receives: Drug: Telaprevir; Drug: Peg-IFN-alfa-2a + Ribavirin (Standard Treatment) |
| TVR with Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Experimental | Participants 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. Receives: Drug: Telaprevir; Drug: Peg-IFN-alfa-2a + Ribavirin (Standard Treatment) |
| Pbo with Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | Active comparator | Participants 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. Receives: Drug: Peg-IFN-alfa-2a + Ribavirin (Standard Treatment); Drug: Placebo |
| TVR then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | Experimental | Participants 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. Receives: Drug: Telaprevir; Drug: Peg-IFN-alfa-2a + Ribavirin (Standard Treatment) |
| TVR with Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Experimental | Participants 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. Receives: Drug: Telaprevir; Drug: Peg-IFN-alfa-2a + Ribavirin (Standard Treatment) |
| Pbo with Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 | Active comparator | Participants 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. Receives: Drug: Peg-IFN-alfa-2a + Ribavirin (Standard Treatment); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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
Levels of HCV RNA in plasma were measured using COBAS TaqMan HCV test v2.0. Lower limit of quantification was 25 IU/ml and limit of detection was 10 IU/ml. The assay used real time RT-PCR methodology. End of treatment (EOT) for group T2 \& PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.
Measured: Baseline and Week 24/26
Maximum Plasma Concentration (Cmax) for Telaprevir on Day 15
The Cmax is defined as the maximum observed analyte concentration. The Cmax is measured in ng/ml.
Measured: Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr)
Minimum Plasma Concentration (Cmin) for Telaprevir on Day 15
The Cmin is defined as minimum plasma concentration between 0 hr and dosing interval. The Cmin is measured in ng/ml.
Measured: 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)
Virological response was defined as having HCV RNA level less than a particular threshold that is less than 10 IU/ml (undetectable).
Measured: Baseline, Day 12, 15, Week 4, 6, 14 and EOT (Week 24/26 or early discontinuation)
Median Time to Virological Response (HCV RNA Level < 10 IU/ml)
Virological response was defined as having HCV RNA level less than a particular threshold which is either less than 10 IU/ml (undetectable) or less than 25 IU/ml (unquantifiable).Time to virological response was defined as the number of days from the start of medication intake necessary to go for the first time below the threshold value. The EOT for group T2 \& PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.
Measured: Baseline up to EOT
Percentage of Participants With Viral Breakthrough
Viral breakthrough was defined as an increase in HCV RNA levels by more than 1 log10 in HCV RNA level from the lowest level reached, or a value of HCV RNA > 100 IU/ml in participants whose HCV RNA had previously become undetectable (< 10 IU/ml) or unquantifiable (< 25 IU/ml) during the considered treatment phase. It was considered as confirmed when the criterion for viral breakthrough is fulfilled at two or more consecutive time points or at the last observed time point in case of trial termination. The EOT for group T2 \& PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.
Measured: Baseline, Day 12, 15 and Week 24/26
Percentage of Participants Who Demonstrated Virological Relapse
Relapse was defined as confirmed detectable HCV RNA (>=10 IU/ml) during the follow-up period up to 24 weeks after last medication intake and after previous undetectable HCV RNA (< 10 IU/ml) at EOT. No relapse was defined as having no confirmed detectable HCV RNA (>=10 IU/ml) during the follow-up period and after previous undetectable HCV RNA (< 10 IU/ml) at EOT. Missing follow-up means no HCV RNA measurements during the follow-up period and after previous undetectable HCV RNA (< 10 IU/ml) at EOT. The EOT for group T2 \& PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.
Measured: 24 weeks after EOT
Percentage of Participants Who Achieved Sustained Virological Response (SVR)
The SVR was defined as having HCV RNA undetectable at EOT, not showing relapse up to follow-up Week 12 (SVR12) or follow-up Week 24 (SVR24), and HCV RNA undetectable at follow-up Week 12 (SVR12) or follow-up Week 24 (SVR24), respectively. The EOT for group T2 \& PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.
Measured: Week 12, 24 after EOT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2007 (estimated)
- Study startDec 2007
- Primary completionJun 2008
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tibotec BVBA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tibotec-Virco Virology BVBA Clinical Trial, Study director, Tibotec BVBA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00561015
- Sponsor's protocol ID
- CR013513
- Other IDs
- VX-950-TiDP24-C209
- Status last verified
- Jun 2013
- First submitted
- 19 Nov 2007
- Last updated
- 17 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Randomized, Partially Blinded Trial of Telaprevir (VX-950) in Treatment-Naive Subjects With Chronic Genotype 2 or 3 Hepatitis C Infection
- ClinicalTrials.gov ID
- NCT00561015
- Acronym / sponsor ID
- CR013513
- Conditions
- Hepatitis C, Chronic
- Keywords
- Hepatitis C, Chronic, Genotype 2, Genotype 3, Telaprevir
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Tibotec BVBAIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 20 Nov 2007 (estimated)
- Results
- Posted 4 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a Phase 2a multicenter (when more than one hospital or medical school team work on a medical research study), partially blinded, randomized (study drug assigned by chance) stratified (arrange in groups for analysis of results e.g., stratify by age, sex, etc.) for genotype, multiple dose study. The trial will consist of Screening period (6 weeks), Treatment period (24 or 26 weeks) and Follow-up period (24 weeks). The Treatment period will include 2 weeks investigational treatment phase and a 24 week standard treatment phase. All the eligible participants who were never treated for HCV will be enrolled for the trial and will receive the investigational treatment regimen to which they have been randomly assigned for 2 weeks. After this in the standard treatment phase participants will receive the standard treatment of care consisting of pegylated interferon (Peg-IFN)-alfa-2a 180 microgram once weekly and ribavirin (RBV) 400 milligram twice per day. Efficacy will primarily be evaluated by HCV viral load quantification. Participant's safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| TVR then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | Experimental | Drug: Telaprevir, Drug: Peg-IFN-alfa-2a + Ribavirin (Standard Treatment)Participants 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 | Experimental | Drug: Telaprevir, Drug: Peg-IFN-alfa-2a + Ribavirin (Standard Treatment)Participants 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 comparator | Drug: Peg-IFN-alfa-2a + Ribavirin (Standard Treatment), Drug: PlaceboParticipants 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 | Experimental | Drug: Telaprevir, Drug: Peg-IFN-alfa-2a + Ribavirin (Standard Treatment)Participants 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 | Experimental | Drug: Telaprevir, Drug: Peg-IFN-alfa-2a + Ribavirin (Standard Treatment)Participants 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 comparator | Drug: Peg-IFN-alfa-2a + Ribavirin (Standard Treatment), Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelaprevirAlso: VX-950Telaprevir 750 mg tablet will be administered three times a day orally for 2 weeks. | Drug | TVR then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2, TVR then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3, TVR with Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2, TVR with Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 |
| Peg-IFN-alfa-2a + Ribavirin (Standard Treatment)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. | Drug | Pbo with Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2, Pbo with Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3, TVR then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2, TVR then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3, TVR with Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2, TVR with Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 |
| PlaceboMatching placebo tablet to telaprevir will be administered three times a day orally for 2 weeks. | Drug | Pbo with Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2, Pbo with Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 |
Primary outcome
Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Day 15
Time frame: Baseline, Pre-dose (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.
Maximum Plasma Concentration (Cmax) for Telaprevir on Day 1
Time frame: Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hour [hr])
The Cmax is defined as the maximum observed analyte concentration. The Cmax was measured in nanogram/milliliter (ng/ml).
Time to Reach Maximum Plasma Concentration (Tmax) for Telaprevir on Day 1
Time frame: Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hr)
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.
Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 1
Time frame: Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hr)
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.
9 secondary outcomes
Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 15
Time frame: 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
Time frame: Baseline and Week 24/26
Maximum Plasma Concentration (Cmax) for Telaprevir on Day 15
Time frame: Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr)
Minimum Plasma Concentration (Cmin) for Telaprevir on Day 15
Time frame: 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)
Time frame: Baseline, Day 12, 15, Week 4, 6, 14 and EOT (Week 24/26 or early discontinuation)
Median Time to Virological Response (HCV RNA Level < 10 IU/ml)
Time frame: Baseline up to EOT
Percentage of Participants With Viral Breakthrough
Time frame: Baseline, Day 12, 15 and Week 24/26
Percentage of Participants Who Demonstrated Virological Relapse
Time frame: 24 weeks after EOT
Percentage of Participants Who Achieved Sustained Virological Response (SVR)
Time frame: Week 12, 24 after EOT
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tibotec-Virco Virology BVBA Clinical Trial study director
Tibotec BVBA
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Telaprevir and Peg-IFN-alfa-2a + Ribavirin (Standard Treatment) in people with Hepatitis C, Chronic, run by Tibotec BVBA at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France, Sweden, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Day 15 (time frame: Baseline, Pre-dose (Day 15)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2013; AzTrials last refreshed its copy on 31 Oct 2026.