search
Back to results

An Open-Label Study of Telaprevir Administered Every 12 or 8 Hours in Combination With One of Two Pegylated Interferons and Ribavirin in Treatment-Naive Genotype 1 Chronic Hepatitis C Participants

Primary Purpose

Chronic Hepatitis C

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Telaprevir
Peg-IFN-alfa-2a
Peg-IFN-alfa-2b
Ribavirin (RBV) tablet
Ribavirin (RBV) capsule
Sponsored by
Tibotec BVBA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Chronic Hepatitis C, Genotype 1, Telaprevir, Treatment-naïve, VX-950-C208, VX-950-TiDP24-C208

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic genotype 1 Hepatitis (inflammation of the liver) C infection
  • Never been treated for Hepatitis C Viral (HCV) infection
  • No clinically significant lab abnormalities
  • Amount of HCV Ribonucleic acid (RNA) in the blood more than 10,000 international units/milliliter (IU/mL) at entry
  • Liver biopsy or "Fibroscan" test performed during screening or in the past 3 years

Exclusion Criteria:

  • Contra-indications for starting anti-HCV therapy
  • 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
  • Any evidence of significant liver disease in addition to Hepatitis C
  • Infected with Human Immunodeficiency Virus (a life-threatening infection which you can get from an infected person's blood or from having sex with an infected person) or Hepatitis B
  • Women who are pregnant (carrying an unborn baby), planning to be pregnant or breastfeeding or the partner of a woman who is pregnant or breastfeeding

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Telaprevir 750 mg with Peg-IFN-alfa-2a/RBV tablet

Telaprevir 750 mg with Peg-IFN-alfa-2b/RBV capsule

Telaprevir 1125 mg with Peg-IFN-alfa-2a/RBV tablet

Telaprevir 1125 mg with Peg-IFN-alfa-2b/RBV capsule

Arm Description

Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.

Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.

Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.

Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.

Outcomes

Primary Outcome Measures

Percentage of Participants With Virologic Response at Week 12
Virologic response was either defined as having undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) (i.e., no HCV RNA was detected in the participants' plasma samples) or less than 25 international units/milliliter (IU/mL) HCV RNA (i.e., the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples).

Secondary Outcome Measures

Time to First Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level
Virologic response was either defined as having undetectable HCV RNA (i.e., no HCV RNA was detected in the participants' plasma samples) or less than 25 IU/mL HCV RNA (i.e., the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples).
Number of Participants With Viral Breakthrough at End of Treatment (EOT)
Viral breakthrough was defined as a confirmed increase of more than 1 log 10 in HCV RNA level from the lowest level reached or a confirmed value of HCV RNA more than 100 IU/mL in participants whose HCV RNA was previously less than 25 IU/mL.
Percentage of Participants With Partial Response
Partial response was defined as having at least 2 log drop in HCV RNA from Baseline, but not having undetectable HCV RNA (i.e., no HCV RNA is detected in the participants' plasma samples).
Change From Baseline in Log 10-Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values at Week 12
Change from baseline in log 10 of Plasma HCV RNA levels were measured using the COBAS TaqMan HCV test (lower limit of quantification 25 IU/mL). The assay used real-time reverse transcription - polymerase chain reaction (RT-PCR) methodology. HCV RNA samples were taken pre-dose of Peg-IFN administration.
Change From Baseline in Log 10-Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values at End of Treatment (EOT)
Change from baseline in log 10 of Plasma HCV RNA levels were measured using the COBAS TaqMan HCV test (lower limit of quantification 25 IU/mL). The assay used real-time reverse transcription - polymerase chain reaction (RT-PCR) methodology.
Percentage of Participants With Sustained Viral Response 24 Weeks After End of Treatment (SVR24)
SVR24 was defined as having undetectable HCV RNA (i.e., no HCV RNA is detected in the participants' plasma samples) at EOT and no confirmed detectable HCV RNA levels between EOT and 24 weeks after the last dose of study medication.

Full Information

First Posted
September 10, 2007
Last Updated
June 13, 2014
Sponsor
Tibotec BVBA
search

1. Study Identification

Unique Protocol Identification Number
NCT00528528
Brief Title
An Open-Label Study of Telaprevir Administered Every 12 or 8 Hours in Combination With One of Two Pegylated Interferons and Ribavirin in Treatment-Naive Genotype 1 Chronic Hepatitis C Participants
Official Title
A Phase IIa Randomized, Open-Label Study of Telaprevir (VX-950) Administered Every 12 or Every 8 Hours in Combination With Either Peg-IFN alfa2a (Pegasys) and Ribavirin (Copegus) or Peg-IFN alfa2b (PegIntron) and Ribavirin (Rebetol) in Treatment-Naive Subjects With Chronic Genotype 1 Hepatitis C Infection
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tibotec BVBA

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to explore the efficacy, safety, tolerability, pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time), and pharmacokinetic-pharmacodynamic relationships of telaprevir administered in two different doses in combination with two standard therapies commercially available for chronic (lasting a long time) genotype 1 Hepatitis (inflammation of the liver) C virus (HCV) infection.
Detailed Description
This is a Phase 2a, open-label (all people know the identity of the intervention), multicenter trial (conducted in more than one center) in participants with chronic genotype 1 HCV infection. The trial consists of a Screening phase of approximately 4 weeks, a treatment phase up to 48 weeks depending on participants' individual virologic response, and a follow-up phase of at least 24 weeks. All participants will receive 12 weeks of telaprevir treatment in combination with standard therapy. At Week 12, telaprevir dosing will end and participants will continue on standard therapy only. Participants will be randomly assigned to receive one of the two different dosage regimens of telaprevir (750 milligram [mg] every 8 hours (hr), or 1125 mg every 12 hr) in combination with standard therapy (pegylated interferon [Peg-IFN]-alfa-2a and ribavirin [RBV] or Peg-IFN-alfa-2b and RBV at the standard doses). Efficacy will be evaluated by HCV Ribonucleic Acid (RNA) values, viral response, viral breakthrough, partial response, early viral kinetics and sustained viral response. Pharmacokinetics, Pharmacokinetic-pharmacodynamic relationship will also be evaluated. Safety will be monitored throughout the study duration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
Chronic Hepatitis C, Genotype 1, Telaprevir, Treatment-naïve, VX-950-C208, VX-950-TiDP24-C208

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
166 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telaprevir 750 mg with Peg-IFN-alfa-2a/RBV tablet
Arm Type
Experimental
Arm Description
Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
Arm Title
Telaprevir 750 mg with Peg-IFN-alfa-2b/RBV capsule
Arm Type
Experimental
Arm Description
Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
Arm Title
Telaprevir 1125 mg with Peg-IFN-alfa-2a/RBV tablet
Arm Type
Experimental
Arm Description
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
Arm Title
Telaprevir 1125 mg with Peg-IFN-alfa-2b/RBV capsule
Arm Type
Experimental
Arm Description
Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
Intervention Type
Drug
Intervention Name(s)
Telaprevir
Intervention Description
Oval tablets containing 375 mg of telaprevir for oral administration.
Intervention Type
Drug
Intervention Name(s)
Peg-IFN-alfa-2a
Intervention Description
Solution containing Peg-IFN alfa2a for subcutaneous injection in a pre-filled syringe.
Intervention Type
Drug
Intervention Name(s)
Peg-IFN-alfa-2b
Intervention Description
Powder containing Peg-IFN-alfa-2b and solvent for solution for subcutaneous injection in a pre-filled pen.
Intervention Type
Drug
Intervention Name(s)
Ribavirin (RBV) tablet
Intervention Description
Tablets containing 200 mg RBV for oral administration.
Intervention Type
Drug
Intervention Name(s)
Ribavirin (RBV) capsule
Intervention Description
Capsules containing 200 mg RBV for oral administration.
Primary Outcome Measure Information:
Title
Percentage of Participants With Virologic Response at Week 12
Description
Virologic response was either defined as having undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) (i.e., no HCV RNA was detected in the participants' plasma samples) or less than 25 international units/milliliter (IU/mL) HCV RNA (i.e., the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples).
Time Frame
End of treatment (EOT) (up to Week 48)
Secondary Outcome Measure Information:
Title
Time to First Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level
Description
Virologic response was either defined as having undetectable HCV RNA (i.e., no HCV RNA was detected in the participants' plasma samples) or less than 25 IU/mL HCV RNA (i.e., the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples).
Time Frame
Baseline (Day 1) up to EOT (up to Week 48)
Title
Number of Participants With Viral Breakthrough at End of Treatment (EOT)
Description
Viral breakthrough was defined as a confirmed increase of more than 1 log 10 in HCV RNA level from the lowest level reached or a confirmed value of HCV RNA more than 100 IU/mL in participants whose HCV RNA was previously less than 25 IU/mL.
Time Frame
EOT (up to Week 48)
Title
Percentage of Participants With Partial Response
Description
Partial response was defined as having at least 2 log drop in HCV RNA from Baseline, but not having undetectable HCV RNA (i.e., no HCV RNA is detected in the participants' plasma samples).
Time Frame
Baseline (Day 1) up to EOT (up to Week 48)
Title
Change From Baseline in Log 10-Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values at Week 12
Description
Change from baseline in log 10 of Plasma HCV RNA levels were measured using the COBAS TaqMan HCV test (lower limit of quantification 25 IU/mL). The assay used real-time reverse transcription - polymerase chain reaction (RT-PCR) methodology. HCV RNA samples were taken pre-dose of Peg-IFN administration.
Time Frame
Baseline (pre-dose), Week 12
Title
Change From Baseline in Log 10-Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values at End of Treatment (EOT)
Description
Change from baseline in log 10 of Plasma HCV RNA levels were measured using the COBAS TaqMan HCV test (lower limit of quantification 25 IU/mL). The assay used real-time reverse transcription - polymerase chain reaction (RT-PCR) methodology.
Time Frame
Baseline (pre-dose), EOT (up to Week 48)
Title
Percentage of Participants With Sustained Viral Response 24 Weeks After End of Treatment (SVR24)
Description
SVR24 was defined as having undetectable HCV RNA (i.e., no HCV RNA is detected in the participants' plasma samples) at EOT and no confirmed detectable HCV RNA levels between EOT and 24 weeks after the last dose of study medication.
Time Frame
EOT (up to Week 48) and up to 24 weeks after EOT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic genotype 1 Hepatitis (inflammation of the liver) C infection Never been treated for Hepatitis C Viral (HCV) infection No clinically significant lab abnormalities Amount of HCV Ribonucleic acid (RNA) in the blood more than 10,000 international units/milliliter (IU/mL) at entry Liver biopsy or "Fibroscan" test performed during screening or in the past 3 years Exclusion Criteria: Contra-indications for starting anti-HCV therapy 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 Any evidence of significant liver disease in addition to Hepatitis C Infected with Human Immunodeficiency Virus (a life-threatening infection which you can get from an infected person's blood or from having sex with an infected person) or Hepatitis B Women who are pregnant (carrying an unborn baby), planning to be pregnant or breastfeeding or the partner of a woman who is pregnant or breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tibotec-Virco Virology BVBA Clinical Trial
Organizational Affiliation
Tibotec BVBA
Official's Role
Study Director
Facility Information:
City
Wien
Country
Austria
City
Brussels
Country
Belgium
City
Bruxelles
Country
Belgium
City
Gent
Country
Belgium
City
Leuven
Country
Belgium
City
Liège
Country
Belgium
City
Angers Cedex 9
Country
France
City
Clichy
Country
France
City
Grenoble
Country
France
City
Lille Cedex
Country
France
City
Nice
Country
France
City
Paris Cedex 12
Country
France
City
Paris
Country
France
City
Vandoeuvre Les Nancy
Country
France
City
Düsseldorf
Country
Germany
City
Frankfurt N/A
Country
Germany
City
Freiburg
Country
Germany
City
Hamburg
Country
Germany
City
Hannover
Country
Germany
City
Koln
Country
Germany
City
Tübingen
Country
Germany
City
Leiden
Country
Netherlands
City
Nijmegen
Country
Netherlands
City
Barcelona
Country
Spain
City
Madrid
Country
Spain
City
Valencia
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
22387529
Citation
Serfaty L, Forns X, Goeser T, Ferenci P, Nevens F, Carosi G, Drenth JP, Lonjon-Domanec I, DeMasi R, Picchio G, Beumont M, Marcellin P. Insulin resistance and response to telaprevir plus peginterferon alpha and ribavirin in treatment-naive patients infected with HCV genotype 1. Gut. 2012 Oct;61(10):1473-80. doi: 10.1136/gutjnl-2011-300749. Epub 2012 Mar 2.
Results Reference
derived

Learn more about this trial

An Open-Label Study of Telaprevir Administered Every 12 or 8 Hours in Combination With One of Two Pegylated Interferons and Ribavirin in Treatment-Naive Genotype 1 Chronic Hepatitis C Participants

We'll reach out to this number within 24 hrs