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An Exploratory Study of Telaprevir in Treatment-Naive Participants With Chronic Genotype 4 Hepatitis C Virus Infection

Primary Purpose

Hepatitis C

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Telaprevir
Pegylated-interferon-alfa-2a
Placebo
Ribavirin
Sponsored by
Tibotec BVBA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis C, Telaprevir, Pegylated-interferon-alfa-2a, Pegasys, Ribavirin, Copegus

Eligibility Criteria

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

Inclusion Criteria: - Participant has chronic Genotype 4 Hepatitis C infection

  • 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
  • Participant had to be willing to refrain from the concomitant use of any medications or substances Exclusion Criteria: - Participants with history or evidence of cirrhosis or history of suspicion of alcohol, barbiturate, or amphetamine recreational or narcotic drug use, which in the Investigator's opinion would compromise the participant's safety and/or compliance with study procedures
  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Telaprevir and then Pegylated-interferon-alfa-2a+Ribavirin

    Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin

    Placebo+Pegylated-interferon-alfa-2a+Ribavirin

    Arm Description

    Telaprevir 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 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.

    Matching 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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Percentage of Participants With Viral Response (Undetectable HCV RNA)
    Viral response was either defined as having undetectable HCV RNA (that is, no HCV RNA was detected in the participants' plasma samples) or less than 25 IU/mL HCV RNA from Day 15 up to end of treatment (EOT), that is Week 48/50 or early discontinuation. In Week x/y, where, x represents time frame for Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin and Placebo+Pegylated-interferon-alfa-2a+Ribavirin and; y represents time frame for Telaprevir and Pegylated-interferon-alfa-2a+Ribavirin treatment group.
    Median Time to First Viral Response (Undetectable HCV RNA)
    Time to first viral response (Undetectable HCV RNA) is defined as the number of days since the start of study medication until first time negative HCV RNA level that is less than 25 IU/mL was detected.
    Number of Participants With Viral Breakthrough (Detectable HCV RNA)
    Viral breakthrough was defined as having a confirmed increase greater than 1 log 10 in HCV RNA level from the lowest level reached, or a confirmed level of HCV RNA greater than 100 IU/mL in participants whose HCV RNA had previously become undetectable [less than 25 IU/mL]). In Week x/y, where, x represents time frame for Telaprevir+pegylated-interferon-alfa-2a+Ribavirin and Placebo+pegylated-interferon-alfa-2a+Ribavirin and y represents time frame for Telaprevir and then Pegylated-interferon-alfa-2a+Ribavirin treatment group.
    Percentage of Participants With Sustained Viral Response (SVR)
    Sustained viral response was defined as having undetectable HCV RNA at EOT (Week 48/50 or early discontinuation) and no confirmed detectable HCV RNA levels between EOT and 12 weeks (SVR12) and 24 weeks (SVR24) after the last dose of study medication.
    Percentage of Participants With Relapse
    Relapse was defined as having confirmed detectable HCV RNA during the 24-week follow-up period in participants who had undetectable HCV RNA at EOT (Week 48/50 or early discontinuation). Participants who dropped out between 24-week follow-up after EOT were not evaluated for relapse.
    Area Under the Serum Concentration-Time Curve (AUC)
    The AUC is a measure of the serum concentration-time curve, calculated by the lin-up/log-down method.
    Maximum Serum Concentration (Cmax) of Telaprevir
    The Cmax is the maximum observed serum concentration, which was measured at Day 1 and 15 for telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test).
    Pre-Dose Serum Concentration (C[0h]) of Telaprevir
    The C(0h) is the pre-dose serum concentration of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test).
    Minimum Serum Concentration (Cmin) of Telaprevir on Day 15
    The Cmin is the minimum serum concentration between 0 hour and τ (τ=dosing interval) of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test). Cmin on Day 15 is reported here.
    Time to Reach the Maximum Serum Concentration (Tmax) of Telaprevir
    The tmax is the time to reach maximum observed serum concentration of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and pegylated-interferon-alfa-2a+Ribavirin (test).
    Average Steady-State Serum Concentration (Css,av) of Telaprevir
    The Average steady-state serum concentration (Css,av) was calculated by AUC/τ at steady-state (τ=dosing interval) of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test).

    Full Information

    First Posted
    December 20, 2007
    Last Updated
    August 27, 2013
    Sponsor
    Tibotec BVBA
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00580801
    Brief Title
    An Exploratory Study of Telaprevir in Treatment-Naive Participants With Chronic Genotype 4 Hepatitis C Virus Infection
    Official Title
    A Phase IIa Randomized, Partially Blinded Trial of Telaprevir (VX-950) in Treatment-Naive Subjects With Chronic Genotype 4 Hepatitis C Infection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2008 (undefined)
    Primary Completion Date
    January 2010 (Actual)
    Study Completion Date
    January 2010 (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 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.
    Detailed Description
    This is a Phase 2a, partially-blind, randomized (study drug assigned by chance) and multiple-dose study to evaluate the activity and safety of telaprevir on HCV early viral kinetics in treatment-naive participants who are chronically infected with HCV Genotype 4. The study consists of 4 parts: Screening period (6-week); Investigational Treatment period (consisting of 2-week treatment with telaprevir or telaprevir+standard treatment or placebo); Standard Treatment period (consists of 46 or 48-week standard treatment); and Follow-up period (24-week). The activity of telaprevir will be evaluated by early viral kinetic parameters along with viral response and pharmacokinetic assessments during the investigational treatment phase. Participants' safety will be monitored throughout the study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis C
    Keywords
    Hepatitis C, Telaprevir, Pegylated-interferon-alfa-2a, Pegasys, Ribavirin, Copegus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Telaprevir and then Pegylated-interferon-alfa-2a+Ribavirin
    Arm Type
    Experimental
    Arm Description
    Telaprevir 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.
    Arm Title
    Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin
    Arm Type
    Experimental
    Arm Description
    Telaprevir 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.
    Arm Title
    Placebo+Pegylated-interferon-alfa-2a+Ribavirin
    Arm Type
    Active Comparator
    Arm Description
    Matching 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.
    Intervention Type
    Drug
    Intervention Name(s)
    Telaprevir
    Intervention Description
    Telaprevir 750 milligram (mg) tablet will be administered three times a day orally for 2 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Pegylated-interferon-alfa-2a
    Intervention Description
    Pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection, once weekly) will be administered from Week 1 to Week 48 or 50.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Ribavirin
    Intervention Description
    Ribavirin (1000-1200 mg as oral tablet daily) will be administered from Week 1 to Week 48 or 50.
    Primary Outcome Measure Information:
    Title
    Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Day 15
    Description
    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.
    Time Frame
    Baseline and Day 15
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants With Viral Response (Undetectable HCV RNA)
    Description
    Viral response was either defined as having undetectable HCV RNA (that is, no HCV RNA was detected in the participants' plasma samples) or less than 25 IU/mL HCV RNA from Day 15 up to end of treatment (EOT), that is Week 48/50 or early discontinuation. In Week x/y, where, x represents time frame for Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin and Placebo+Pegylated-interferon-alfa-2a+Ribavirin and; y represents time frame for Telaprevir and Pegylated-interferon-alfa-2a+Ribavirin treatment group.
    Time Frame
    Day 15 up to EOT (Week 48/50 or early discontinuation)
    Title
    Median Time to First Viral Response (Undetectable HCV RNA)
    Description
    Time to first viral response (Undetectable HCV RNA) is defined as the number of days since the start of study medication until first time negative HCV RNA level that is less than 25 IU/mL was detected.
    Time Frame
    Up to Week 48/50
    Title
    Number of Participants With Viral Breakthrough (Detectable HCV RNA)
    Description
    Viral breakthrough was defined as having a confirmed increase greater than 1 log 10 in HCV RNA level from the lowest level reached, or a confirmed level of HCV RNA greater than 100 IU/mL in participants whose HCV RNA had previously become undetectable [less than 25 IU/mL]). In Week x/y, where, x represents time frame for Telaprevir+pegylated-interferon-alfa-2a+Ribavirin and Placebo+pegylated-interferon-alfa-2a+Ribavirin and y represents time frame for Telaprevir and then Pegylated-interferon-alfa-2a+Ribavirin treatment group.
    Time Frame
    Day 8, Day 12, Day 15, Week 24/26 and Week 36/38
    Title
    Percentage of Participants With Sustained Viral Response (SVR)
    Description
    Sustained viral response was defined as having undetectable HCV RNA at EOT (Week 48/50 or early discontinuation) and no confirmed detectable HCV RNA levels between EOT and 12 weeks (SVR12) and 24 weeks (SVR24) after the last dose of study medication.
    Time Frame
    Week 12 and 24 after the last dose of study medication
    Title
    Percentage of Participants With Relapse
    Description
    Relapse was defined as having confirmed detectable HCV RNA during the 24-week follow-up period in participants who had undetectable HCV RNA at EOT (Week 48/50 or early discontinuation). Participants who dropped out between 24-week follow-up after EOT were not evaluated for relapse.
    Time Frame
    Week 24 after EOT (Week 48/50 or early discontinuation)
    Title
    Area Under the Serum Concentration-Time Curve (AUC)
    Description
    The AUC is a measure of the serum concentration-time curve, calculated by the lin-up/log-down method.
    Time Frame
    Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15
    Title
    Maximum Serum Concentration (Cmax) of Telaprevir
    Description
    The Cmax is the maximum observed serum concentration, which was measured at Day 1 and 15 for telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test).
    Time Frame
    Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15
    Title
    Pre-Dose Serum Concentration (C[0h]) of Telaprevir
    Description
    The C(0h) is the pre-dose serum concentration of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test).
    Time Frame
    0 hour (pre-dose) at Day 15
    Title
    Minimum Serum Concentration (Cmin) of Telaprevir on Day 15
    Description
    The Cmin is the minimum serum concentration between 0 hour and τ (τ=dosing interval) of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test). Cmin on Day 15 is reported here.
    Time Frame
    Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 15
    Title
    Time to Reach the Maximum Serum Concentration (Tmax) of Telaprevir
    Description
    The tmax is the time to reach maximum observed serum concentration of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and pegylated-interferon-alfa-2a+Ribavirin (test).
    Time Frame
    Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15
    Title
    Average Steady-State Serum Concentration (Css,av) of Telaprevir
    Description
    The Average steady-state serum concentration (Css,av) was calculated by AUC/τ at steady-state (τ=dosing interval) of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test).
    Time Frame
    Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15

    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: - Participant has chronic Genotype 4 Hepatitis C infection 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 Participant had to be willing to refrain from the concomitant use of any medications or substances Exclusion Criteria: - Participants with history or evidence of cirrhosis or history of suspicion of alcohol, barbiturate, or amphetamine recreational or narcotic drug use, which in the Investigator's opinion would compromise the participant's safety and/or compliance with study procedures 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
    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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24886541
    Citation
    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.
    Results Reference
    derived

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    An Exploratory Study of Telaprevir in Treatment-Naive Participants With Chronic Genotype 4 Hepatitis C Virus Infection

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