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Telaprevir, Peg-IFN-alfa-2a, and RBV in Treatment-Experienced Black/African American and Non-Black/African American Subjects With Genotype 1 Chronic Hepatitis C

Sponsor
Vertex Pharmaceuticals Incorporated (Industry)
Overall Status
Terminated
CT.gov ID
NCT01467492
Collaborator
(none)
121
Enrollment
27
Locations
2
Arms
28
Duration (Months)
4.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV) in treatment-experienced Black/African American and non-Black/African American participants with Genotype 1 Chronic Hepatitis C (CHC), who have not achieved a sustained viral response with a prior course of interferon-based therapy.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

This is a single-arm, open-label, multicenter study of treatment-experienced participants with Genotype 1 CHC, who self-identified as Black/African American (Group A) or who did not self-identify as Black/African American (Group B). Participants did not achieve a sustained virologic response 24 weeks after at least 1 prior course of Peg-IFN-alfa-2a/RBV therapy of standard duration, and have 1 of the following viral responses:

  • Prior relapse: Participant had a documented undetectable hepatitis C virus ribonucleic acid (HCV RNA) level at the planned end of treatment of at least 42 weeks duration (HCV RNA evaluated anytime between 3 weeks before and 6 weeks after the last dose of Peg IFN-alfa-2a or RBV).

  • Prior null response: Participant had a <2-log10 decrease in HCV RNA at 12 weeks, during prior Peg IFN-alfa-2a/RBV treatment, but never achieved undetectable HCV RNA while on treatment.

  • Prior partial response: Participant had a >=2-log10 decrease in HCV RNA at 12 weeks, during prior Peg IFN-alfa-2a/RBV treatment, but never achieved undetectable HCV RNA while on treatment.

Study Design

Study Type:
Interventional
Actual Enrollment :
121 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label, Phase 4 Study of Telaprevir, Peginterferon Alfa-2a (Pegasys®), and Ribavirin (Copegus®) in Treatment-Experienced Black/African American and Non-Black/African American Subjects With Genotype 1 Chronic Hepatitis C Who Have Not Achieved a Sustained Viral Response With a Prior Course of Interferon-Based Therapy
Study Start Date :
Jan 1, 2012
Actual Primary Completion Date :
May 1, 2014
Actual Study Completion Date :
May 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Black

Telaprevir 750 milligram (mg) tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 microgram per week (mcg/week) subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 milligram per day (mg/day) (for participants weighing <75 kilograms [kg]) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.

Drug: Telaprevir
Tablet
Other Names:
  • Incivek, VX-950

    • Drug: Ribavirin
    Tablet
    Other Names:
  • Copegus®, RBV

    • Biological: Pegylated Interferon Alfa-2a
    Subcutaneous Injection
    Other Names:
  • Pegasys®, Peg-IFN-Alfa-2a

    		•
    Experimental: Non-Black

    Telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.

    Drug: Telaprevir
    Tablet
    Other Names:
  • Incivek, VX-950

    • Drug: Ribavirin
    Tablet
    Other Names:
  • Copegus®, RBV

    • Biological: Pegylated Interferon Alfa-2a
    Subcutaneous Injection
    Other Names:
  • Pegasys®, Peg-IFN-Alfa-2a

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With Sustained Viral Response 12 Weeks After Last Actual Dose of Study Drug (SVR12) [12 weeks after last actual dose of study drug (up to Week 60)]

      SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (<lower limit of quantification) at 12 weeks after last actual dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).

    Secondary Outcome Measures

    1. Percentage of Participants With Sustained Viral Response 24 Weeks After Last Actual Dose of Study Drug (SVR24) [24 weeks after last actual dose of study drug (up to Week 72)]

      SVR24 was defined as an undetectable HCV RNA Levels (<lower limit of quantification) at 24 weeks after last actual dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL.

    2. Percentage of Participants With Extended Rapid Viral Response (eRVR) [Week 4 and Week 12]

      The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. eRVR was defined as undetectable HCV RNA (<lower limit of quantification) at both 4 weeks and 12 weeks after the start of study treatment.

    3. Percentage of Participants With Relapse [4 weeks (Wk) (up to Week 52), 12 weeks (up to Week 60) and 24 weeks (up to Week 72) after actual EOT]

      The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Relapse was defined as having undetectable HCV RNA (<lower limit of quantification) at actual end of treatment (EOT) and followed by detectable HCV RNA (>=lower limit of quantification) during follow-up.

    4. Percentage of Participants With Virologic Breakthrough [Week 2, 4, 8, and 12]

      The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Virologic breakthrough on treatment was defined as an increase of at least 1 log10 from nadir or confirmed detectable HCV RNA (>=lower limit of quantification) after undetectable HCV RNA (<lower limit of quantification). Percentages are calculated by using total number in FA set as denominator, in each category.

    5. Percentage of Participants With On Treatment Virologic Failure [Week 2, 4, 8, 12, 16, 24, 28, 36, 40, and 48]

      On treatment virologic failure was defined as meeting any futility rule or completing assigned treatment duration and having detectable HCV RNA at EOT. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Futility rules: 1) Virologic breakthrough (at least 1 log10 increase from nadir or confirmed detectable HCV RNA after undetectable HCV RNA) from Day 1 through Week 24 or 48 (depending on treatment duration); 2) HCV RNA >1000 IU/mL during Weeks 4 to 12, inclusive; 3) Detectable HCV RNA after Week 12. Percentages are calculated by using total number in FA set as denominator, in each category.

    6. Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Up to Week 52]

      AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes SAE as well as Non-SAEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event.

    7. Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region [up to Week 72]

      Sequence analysis of the HCV NS3-4A region was performed to monitor telaprevir-resistant variants. HCV RNA was isolated from the plasma, amplified by reverse transcription-polymerase chain reaction (RT-PCR), and sequenced (sequencing assay limit of detection HCV RNA >=1000 IU/mL). Results of this outcome measure were to be reported for overall participants instead of by race and by prior response.

    Other Outcome Measures

    1. Plasma Concentration of Telaprevir, Peginterferon Alfa-2a (Peg-IFN) and Ribavirin (RBV) [48 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Participants self-identify as Black/African American (Group A) or did not self-identify as Black/African American (Group B)

    • Participants have Genotype 1 CHC and laboratory evidence of hepatitis C virus (HCV) infection for at least 6 months

    • Participants did not achieve sustained viral response 24 weeks after last dose of study drug (SVR24), after at least 1 prior course of Peg-IFN-alfa-2a/RBV therapy of standard duration

    Exclusion Criteria:

    • Participants have received previous treatment with telaprevir or any other protease inhibitor(s) for CHC

    • Participants who have evidence of hepatic decompensation

    • Participants have diagnosed or suspected hepatocellular carcinoma

    • Participants have any other cause of significant liver disease in addition to HCV

    • Participants are currently abusing illicit drugs or alcohol, or have history of illicit substance or alcohol abuse within 2 years before the screening visit

    • Participants who participated in any investigational drug study within 90 days before dosing

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alabama Birmingham Alabama United States
    2 California San Francisco California United States
    3 Connecticut New Haven Connecticut United States
    4 Washington, DC Washington District of Columbia United States
    5 Florida Miami Florida United States
    6 Florida Orlando Florida United States
    7 Florida Tampa Florida United States
    8 Florida West Palm Beach Florida United States
    9 Georgia Atlanta Georgia United States
    10 Illinois Chicago Illinois United States
    11 Louisiana Baton Rouge Louisiana United States
    12 Louisiana New Orleans Louisiana United States
    13 Louisiana Shreveport Louisiana United States
    14 Maryland Baltimore Maryland United States
    15 Massachusetts Boston Massachusetts United States
    16 Michigan Detroit Michigan United States
    17 New Jersey Vineland New Jersey United States
    18 New York Bronx New York United States
    19 New York New York New York United States
    20 North Carolina Charlotte North Carolina United States
    21 North Carolina Durham North Carolina United States
    22 Pennsylvania Philadelphia Pennsylvania United States
    23 Texas Dallas Texas United States
    24 Texas Houston Texas United States
    25 Texas San Antoinio Texas United States
    26 Virginia Norfolk Virginia United States
    27 Washington Seattle Washington United States

    Sponsors and Collaborators

    • Vertex Pharmaceuticals Incorporated

    Investigators

    • Study Director: Medical Monitor, Vertex Pharmaceuticals Incorporated

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vertex Pharmaceuticals Incorporated
    ClinicalTrials.gov Identifier:
    NCT01467492
    Other Study ID Numbers:
    • VX11-950-116
    First Posted:
    Nov 8, 2011
    Last Update Posted:
    Aug 3, 2015
    Last Verified:
    Jun 1, 2015
    Keywords provided by Vertex Pharmaceuticals Incorporated
    VX-950, Incivek
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis C
    Hepatitis C, Chronic
    Hepatitis
    Interferons
    Ribavirin
    Interferon-alpha
    Interferon alpha-2
    Peginterferon alfa-2a

    Study Results

    Participant Flow

    Recruitment Details Study included Prior Relapser (prior HCV treatment with pegylated interferon alfa/ribavirin [Peg-IFN/RBV] and experienced viral relapse) and Prior Null/Partial Responder (prior HCV treatment with Peg-IFN/RBV and had null/partial response) participants.
    Pre-assignment Detail Efficacy analyses were reported as per Race (Black/Non-Black) (reporting arms) and also separately as per prior response (in categories) (Prior Relapser, Prior Null Responder, Prior Partial Responder as well as for Total Participants), unless otherwise specified.
    Arm/Group Title Group A - Black Group B - Non-Black
    Arm/Group Description Black/African American participants received telaprevir 750 milligram (mg) tablet 3 times per day for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) (for participants weighing <75 kilograms [kg]) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks. Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
    Period Title: Overall Study
    STARTED 83 38
    COMPLETED 61 25
    NOT COMPLETED 22 13

    Baseline Characteristics

    Arm/Group Title Group A - Black Group B - Non-Black Total
    Arm/Group Description Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks. Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks. Total of all reporting groups
    Overall Participants 82 38 120
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    57.7
    (5.59)
    55.8
    (5.95)
    57.1
    (5.76)
    Sex: Female, Male (Count of Participants)
    Female
    34
    41.5%
    6
    15.8%
    40
    33.3%
    Male
    48
    58.5%
    32
    84.2%
    80
    66.7%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants With Sustained Viral Response 12 Weeks After Last Actual Dose of Study Drug (SVR12)
    Description SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (<lower limit of quantification) at 12 weeks after last actual dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).
    Time Frame 12 weeks after last actual dose of study drug (up to Week 60)

    Outcome Measure Data

    Analysis Population Description
    FA Set. Here, n signifies participants who were evaluable for specified category for each arm, respectively.
    Arm/Group Title Group A - Black Group B - Non-Black
    Arm/Group Description Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks. Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
    Measure Participants 82 38
    Prior Null Response (n = 41, 10)
    26.8
    32.7%
    20.0
    52.6%
    Prior Partial Response (n= 20, 6)
    40.0
    48.8%
    33.3
    87.6%
    Prior Relapse ( n= 21, 22)
    66.7
    81.3%
    59.1
    155.5%
    Total (n= 82, 38)
    40.2
    49%
    44.7
    117.6%
    2. Secondary Outcome
    Title Percentage of Participants With Sustained Viral Response 24 Weeks After Last Actual Dose of Study Drug (SVR24)
    Description SVR24 was defined as an undetectable HCV RNA Levels (<lower limit of quantification) at 24 weeks after last actual dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL.
    Time Frame 24 weeks after last actual dose of study drug (up to Week 72)

    Outcome Measure Data

    Analysis Population Description
    FA Set. Here, n signifies participants who were evaluable for specified category for each arm, respectively.
    Arm/Group Title Group A - Black Group B - Non-Black
    Arm/Group Description Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks. Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
    Measure Participants 82 38
    Prior Null Response (n = 41, 10)
    19.5
    23.8%
    20.0
    52.6%
    Prior Partial Response (n= 20, 6)
    30.0
    36.6%
    16.7
    43.9%
    Prior Relapse ( n= 21, 22)
    61.9
    75.5%
    50.0
    131.6%
    Total (n= 82, 38)
    32.9
    40.1%
    36.8
    96.8%
    3. Secondary Outcome
    Title Percentage of Participants With Extended Rapid Viral Response (eRVR)
    Description The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. eRVR was defined as undetectable HCV RNA (<lower limit of quantification) at both 4 weeks and 12 weeks after the start of study treatment.
    Time Frame Week 4 and Week 12

    Outcome Measure Data

    Analysis Population Description
    FA Set. Here, n signifies participants who were evaluable for specified category for each arm, respectively.
    Arm/Group Title Group A - Black Group B - Non-Black
    Arm/Group Description Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks. Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
    Measure Participants 82 38
    Prior Null Response (n = 41, 10)
    24.4
    29.8%
    30.0
    78.9%
    Prior Partial Response (n= 20, 6)
    45.0
    54.9%
    66.7
    175.5%
    Prior Relapse ( n= 21, 22)
    66.7
    81.3%
    68.2
    179.5%
    Total (n= 82, 38)
    40.2
    49%
    57.9
    152.4%
    4. Secondary Outcome
    Title Percentage of Participants With Relapse
    Description The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Relapse was defined as having undetectable HCV RNA (<lower limit of quantification) at actual end of treatment (EOT) and followed by detectable HCV RNA (>=lower limit of quantification) during follow-up.
    Time Frame 4 weeks (Wk) (up to Week 52), 12 weeks (up to Week 60) and 24 weeks (up to Week 72) after actual EOT

    Outcome Measure Data

    Analysis Population Description
    FA Set. Here number of participants analyzed signifies participants with undetectable HCV RNA (HCV RNA <lower limit of quantification) at actual EOT and n signifies participants with undetectable HCV RNA at actual EOT for specified category.
    Arm/Group Title Group A - Black Group B - Non-Black
    Arm/Group Description Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks. Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
    Measure Participants 48 26
    Prior Null Response, 4 Wk After EOT (n=17,3)
    23.5
    28.7%
    33.3
    87.6%
    Prior Null Response, 12 Wk After EOT (n=17,3)
    23.5
    28.7%
    33.3
    87.6%
    Prior Null Response, 24 Wk After EOT (n=17,3)
    29.4
    35.9%
    33.3
    87.6%
    Prior Partial Response, 4Wk After EOT (n=13,4)
    15.4
    18.8%
    50.0
    131.6%
    Prior Partial Response, 12 Wk After EOT (n=13,4)
    23.1
    28.2%
    50.0
    131.6%
    Prior Partial Response, 24 Wk After EOT (n=13,4)
    23.1
    28.2%
    50.0
    131.6%
    Prior Relapse, 4 Wk After EOT (n=18,19)
    11.1
    13.5%
    15.8
    41.6%
    Prior Relapse, 12 Wk After EOT (n=18,19)
    11.1
    13.5%
    26.3
    69.2%
    Prior Relapse, 24 Wk After EOT (n=18,19)
    11.1
    13.5%
    26.3
    69.2%
    Total, 4 Wk After EOT (n=48,26)
    16.7
    20.4%
    23.1
    60.8%
    Total, 12 Wk After EOT (n=48,26)
    18.8
    22.9%
    30.8
    81.1%
    Total, 24 Wk After EOT (n=48,26)
    20.8
    25.4%
    30.8
    81.1%
    5. Secondary Outcome
    Title Percentage of Participants With Virologic Breakthrough
    Description The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Virologic breakthrough on treatment was defined as an increase of at least 1 log10 from nadir or confirmed detectable HCV RNA (>=lower limit of quantification) after undetectable HCV RNA (<lower limit of quantification). Percentages are calculated by using total number in FA set as denominator, in each category.
    Time Frame Week 2, 4, 8, and 12

    Outcome Measure Data

    Analysis Population Description
    FA Set.
    Arm/Group Title Group A - Black Group B - Non-Black
    Arm/Group Description Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks. Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
    Measure Participants 82 38
    Prior Null Response, Week 2
    0
    0%
    0
    0%
    Prior Null Response, Week 4
    1.2
    1.5%
    2.6
    6.8%
    Prior Null Response, Week 8
    3.7
    4.5%
    5.3
    13.9%
    Prior Null Response, Week 12
    6.1
    7.4%
    5.3
    13.9%
    Prior Partial Response, Week 2
    0
    0%
    0
    0%
    Prior Partial Response, Week 4
    2.4
    2.9%
    0
    0%
    Prior Partial Response, Week 8
    2.4
    2.9%
    0
    0%
    Prior Partial Response, Week 12
    2.4
    2.9%
    0
    0%
    Prior Relapse, Week 2
    0
    0%
    0
    0%
    Prior Relapse, Week 4
    0
    0%
    0
    0%
    Prior Relapse, Week 8
    0
    0%
    0
    0%
    Prior Relapse, Week 12
    1.2
    1.5%
    0
    0%
    Total, Week 2
    0
    0%
    0
    0%
    Total, Week 4
    3.7
    4.5%
    2.6
    6.8%
    Total, Week 8
    3.7
    4.5%
    5.3
    13.9%
    Total, Week 12
    9.8
    12%
    5.3
    13.9%
    6. Secondary Outcome
    Title Percentage of Participants With On Treatment Virologic Failure
    Description On treatment virologic failure was defined as meeting any futility rule or completing assigned treatment duration and having detectable HCV RNA at EOT. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Futility rules: 1) Virologic breakthrough (at least 1 log10 increase from nadir or confirmed detectable HCV RNA after undetectable HCV RNA) from Day 1 through Week 24 or 48 (depending on treatment duration); 2) HCV RNA >1000 IU/mL during Weeks 4 to 12, inclusive; 3) Detectable HCV RNA after Week 12. Percentages are calculated by using total number in FA set as denominator, in each category.
    Time Frame Week 2, 4, 8, 12, 16, 24, 28, 36, 40, and 48

    Outcome Measure Data

    Analysis Population Description
    FA Set.
    Arm/Group Title Group A - Black Group B - Non-Black
    Arm/Group Description Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks. Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
    Measure Participants 82 38
    Prior Null Response, Week 2
    0
    0%
    0
    0%
    Prior Null Response, Week 4
    4.9
    6%
    2.6
    6.8%
    Prior Null Response, Week 8
    8.5
    10.4%
    7.9
    20.8%
    Prior Null Response, Week 12
    12.2
    14.9%
    7.9
    20.8%
    Prior Null Response, Week 16
    19.5
    23.8%
    7.9
    20.8%
    Prior Null Response, Week 24
    23.2
    28.3%
    10.5
    27.6%
    Prior Null Response, Week 28
    23.2
    28.3%
    13.2
    34.7%
    Prior Null Response, Week 36
    25.6
    31.2%
    13.2
    34.7%
    Prior Null Response, Week 40
    28.0
    34.1%
    13.2
    34.7%
    Prior Null Response, Week 48
    29.3
    35.7%
    13.2
    34.7%
    Prior Partial Response, Week 2
    0
    0%
    0
    0%
    Prior Partial Response, Week 4
    2.4
    2.9%
    0
    0%
    Prior Partial Response, Week 8
    2.4
    2.9%
    0
    0%
    Prior Partial Response, Week 12
    4.9
    6%
    0
    0%
    Prior Partial Response, Week 16
    4.9
    6%
    2.6
    6.8%
    Prior Partial Response, Week 24
    6.1
    7.4%
    7.9
    20.8%
    Prior Partial Response, Week 28
    6.1
    7.4%
    10.5
    27.6%
    Prior Partial Response, Week 36
    7.3
    8.9%
    10.5
    27.6%
    Prior Partial Response, Week 40
    7.3
    8.9%
    10.5
    27.6%
    Prior Partial Response, Week 48
    7.3
    8.9%
    10.5
    27.6%
    Prior Relapse, Week 2
    0
    0%
    0
    0%
    Prior Relapse, Week 4
    0
    0%
    0
    0%
    Prior Relapse, Week 8
    0
    0%
    0
    0%
    Prior Relapse, Week 12
    1.2
    1.5%
    0
    0%
    Prior Relapse, Week 16
    1.2
    1.5%
    0
    0%
    Prior Relapse, Week 24
    1.2
    1.5%
    2.6
    6.8%
    Prior Relapse, Week 28
    1.2
    1.5%
    2.6
    6.8%
    Prior Relapse, Week 36
    1.2
    1.5%
    2.6
    6.8%
    Prior Relapse, Week 40
    1.2
    1.5%
    5.3
    13.9%
    Prior Relapse, Week 48
    1.2
    1.5%
    5.3
    13.9%
    Total, Week 2
    0
    0%
    0
    0%
    Total, Week 4
    7.3
    8.9%
    2.6
    6.8%
    Total, Week 8
    11.0
    13.4%
    7.9
    20.8%
    Total, Week 12
    18.3
    22.3%
    7.9
    20.8%
    Total, Week 16
    25.6
    31.2%
    10.5
    27.6%
    Total, Week 24
    30.5
    37.2%
    21.1
    55.5%
    Total, Week 28
    30.5
    37.2%
    26.3
    69.2%
    Total, Week 36
    34.1
    41.6%
    26.3
    69.2%
    Total, Week 40
    36.6
    44.6%
    28.9
    76.1%
    Total, Week 48
    37.8
    46.1%
    28.9
    76.1%
    7. Secondary Outcome
    Title Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
    Description AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes SAE as well as Non-SAEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event.
    Time Frame Up to Week 52

    Outcome Measure Data

    Analysis Population Description
    Safety Set.
    Arm/Group Title Group A - Black Group B - Non-Black
    Arm/Group Description Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks. Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
    Measure Participants 82 38
    AE
    96.3
    117.4%
    100.0
    263.2%
    SAE
    8.5
    10.4%
    15.8
    41.6%
    8. Secondary Outcome
    Title Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region
    Description Sequence analysis of the HCV NS3-4A region was performed to monitor telaprevir-resistant variants. HCV RNA was isolated from the plasma, amplified by reverse transcription-polymerase chain reaction (RT-PCR), and sequenced (sequencing assay limit of detection HCV RNA >=1000 IU/mL). Results of this outcome measure were to be reported for overall participants instead of by race and by prior response.
    Time Frame up to Week 72

    Outcome Measure Data

    Analysis Population Description
    FA Set.
    Arm/Group Title All Participants
    Arm/Group Description All enrolled participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
    Measure Participants 120
    Number [participants]
    47
    57.3%
    9. Other Pre-specified Outcome
    Title Plasma Concentration of Telaprevir, Peginterferon Alfa-2a (Peg-IFN) and Ribavirin (RBV)
    Description
    Time Frame 48 weeks

    Outcome Measure Data

    Analysis Population Description
    Pharmacokinetic sampling was not performed as per changes in planned analysis (protocol amendment); hence no data was collected.
    Arm/Group Title Group A - Black Group B - Non-Black
    Arm/Group Description Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks. Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
    Measure Participants 0 0

    Adverse Events

    Time Frame Up to Week 52
    Adverse Event Reporting Description
    Arm/Group Title Group A - Black Group B - Non-Black
    Arm/Group Description Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks. Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
    All Cause Mortality
    Group A - Black Group B - Non-Black
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Group A - Black Group B - Non-Black
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 7/82 (8.5%) 6/38 (15.8%)
    Blood and lymphatic system disorders
    Anaemia 0/82 (0%) 2/38 (5.3%)
    Warm type haemolytic anaemia 1/82 (1.2%) 0/38 (0%)
    Cardiac disorders
    Angina pectoris 0/82 (0%) 1/38 (2.6%)
    Gastrointestinal disorders
    Abdominal pain 1/82 (1.2%) 0/38 (0%)
    Pancreatitis 0/82 (0%) 1/38 (2.6%)
    Vomiting 1/82 (1.2%) 0/38 (0%)
    General disorders
    Fatigue 1/82 (1.2%) 0/38 (0%)
    Infections and infestations
    Cellulitis 1/82 (1.2%) 0/38 (0%)
    Salmonellosis 1/82 (1.2%) 0/38 (0%)
    Urinary tract infection 1/82 (1.2%) 0/38 (0%)
    Injury, poisoning and procedural complications
    Facial bones fracture 0/82 (0%) 1/38 (2.6%)
    Hand fracture 0/82 (0%) 1/38 (2.6%)
    Laceration 0/82 (0%) 1/38 (2.6%)
    Metabolism and nutrition disorders
    Dehydration 1/82 (1.2%) 1/38 (2.6%)
    Hypokalaemia 1/82 (1.2%) 0/38 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia 0/82 (0%) 1/38 (2.6%)
    Nervous system disorders
    Headache 1/82 (1.2%) 0/38 (0%)
    Psychiatric disorders
    Insomnia 0/82 (0%) 1/38 (2.6%)
    Suicidal ideation 0/82 (0%) 1/38 (2.6%)
    Renal and urinary disorders
    Renal failure acute 1/82 (1.2%) 0/38 (0%)
    Vascular disorders
    Accelerated hypertension 1/82 (1.2%) 0/38 (0%)
    Hypotension 0/82 (0%) 1/38 (2.6%)
    Other (Not Including Serious) Adverse Events
    Group A - Black Group B - Non-Black
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 79/82 (96.3%) 38/38 (100%)
    Blood and lymphatic system disorders
    Anaemia 40/82 (48.8%) 19/38 (50%)
    Neutropenia 9/82 (11%) 2/38 (5.3%)
    Thrombocytopenia 1/82 (1.2%) 2/38 (5.3%)
    Lymphopenia 0/82 (0%) 2/38 (5.3%)
    Iron deficiency anaemia 1/82 (1.2%) 0/38 (0%)
    Leukopenia 0/82 (0%) 1/38 (2.6%)
    Lymphadenopathy 0/82 (0%) 1/38 (2.6%)
    Cardiac disorders
    Palpitations 1/82 (1.2%) 2/38 (5.3%)
    Angina pectoris 1/82 (1.2%) 1/38 (2.6%)
    Coronary artery disease 1/82 (1.2%) 0/38 (0%)
    Left ventricular hypertrophy 1/82 (1.2%) 0/38 (0%)
    Ventricular extrasystoles 0/82 (0%) 1/38 (2.6%)
    Congenital, familial and genetic disorders
    Haemorrhagic arteriovenous malformation 1/82 (1.2%) 0/38 (0%)
    Ear and labyrinth disorders
    Ear pain 2/82 (2.4%) 1/38 (2.6%)
    Tinnitus 0/82 (0%) 2/38 (5.3%)
    Endocrine disorders
    Hyperthyroidism 1/82 (1.2%) 0/38 (0%)
    Eye disorders
    Vision blurred 2/82 (2.4%) 3/38 (7.9%)
    Abnormal sensation in eye 1/82 (1.2%) 1/38 (2.6%)
    Eye pain 1/82 (1.2%) 1/38 (2.6%)
    Vitreous floaters 2/82 (2.4%) 0/38 (0%)
    Conjunctival haemorrhage 1/82 (1.2%) 0/38 (0%)
    Dry eye 1/82 (1.2%) 0/38 (0%)
    Eye pruritus 1/82 (1.2%) 0/38 (0%)
    Photophobia 1/82 (1.2%) 0/38 (0%)
    Gastrointestinal disorders
    Nausea 20/82 (24.4%) 17/38 (44.7%)
    Anal pruritus 16/82 (19.5%) 5/38 (13.2%)
    Diarrhoea 7/82 (8.5%) 7/38 (18.4%)
    Haemorrhoids 8/82 (9.8%) 5/38 (13.2%)
    Anorectal discomfort 8/82 (9.8%) 4/38 (10.5%)
    Abdominal pain 4/82 (4.9%) 3/38 (7.9%)
    Vomiting 3/82 (3.7%) 4/38 (10.5%)
    Dyspepsia 2/82 (2.4%) 3/38 (7.9%)
    Abdominal pain upper 3/82 (3.7%) 1/38 (2.6%)
    Constipation 0/82 (0%) 4/38 (10.5%)
    Mouth ulceration 2/82 (2.4%) 2/38 (5.3%)
    Abdominal discomfort 3/82 (3.7%) 0/38 (0%)
    Abdominal pain lower 3/82 (3.7%) 0/38 (0%)
    Faeces discoloured 1/82 (1.2%) 2/38 (5.3%)
    Gastrooesophageal reflux disease 0/82 (0%) 3/38 (7.9%)
    Haematochezia 2/82 (2.4%) 1/38 (2.6%)
    Proctalgia 1/82 (1.2%) 2/38 (5.3%)
    Cheilitis 2/82 (2.4%) 0/38 (0%)
    Dry mouth 1/82 (1.2%) 1/38 (2.6%)
    Gingival pain 1/82 (1.2%) 1/38 (2.6%)
    Haemorrhoidal haemorrhage 0/82 (0%) 2/38 (5.3%)
    Tongue discolouration 2/82 (2.4%) 0/38 (0%)
    Abdominal distension 1/82 (1.2%) 0/38 (0%)
    Anal fissure 1/82 (1.2%) 0/38 (0%)
    Aphthous stomatitis 0/82 (0%) 1/38 (2.6%)
    Dental caries 0/82 (0%) 1/38 (2.6%)
    Eructation 1/82 (1.2%) 0/38 (0%)
    Frequent bowel movements 1/82 (1.2%) 0/38 (0%)
    Inguinal hernia 0/82 (0%) 1/38 (2.6%)
    Oesophageal spasm 0/82 (0%) 1/38 (2.6%)
    Oral lichen planus 1/82 (1.2%) 0/38 (0%)
    Rectal haemorrhage 1/82 (1.2%) 0/38 (0%)
    Retching 0/82 (0%) 1/38 (2.6%)
    Stomatitis 0/82 (0%) 1/38 (2.6%)
    Toothache 1/82 (1.2%) 0/38 (0%)
    General disorders
    Fatigue 31/82 (37.8%) 26/38 (68.4%)
    Influenza like illness 15/82 (18.3%) 7/38 (18.4%)
    Injection site erythema 9/82 (11%) 4/38 (10.5%)
    Chills 8/82 (9.8%) 4/38 (10.5%)
    Pyrexia 5/82 (6.1%) 3/38 (7.9%)
    Injection site rash 4/82 (4.9%) 2/38 (5.3%)
    Asthenia 2/82 (2.4%) 3/38 (7.9%)
    Malaise 2/82 (2.4%) 1/38 (2.6%)
    Oedema peripheral 2/82 (2.4%) 1/38 (2.6%)
    Pain 0/82 (0%) 3/38 (7.9%)
    Chest pain 2/82 (2.4%) 0/38 (0%)
    Adverse drug reaction 1/82 (1.2%) 0/38 (0%)
    Chest discomfort 1/82 (1.2%) 0/38 (0%)
    Crying 1/82 (1.2%) 0/38 (0%)
    Feeling abnormal 0/82 (0%) 1/38 (2.6%)
    Feeling jittery 0/82 (0%) 1/38 (2.6%)
    Injection site bruising 0/82 (0%) 1/38 (2.6%)
    Injection site discolouration 1/82 (1.2%) 0/38 (0%)
    Injection site discomfort 1/82 (1.2%) 0/38 (0%)
    Injection site reaction 0/82 (0%) 1/38 (2.6%)
    Local swelling 0/82 (0%) 1/38 (2.6%)
    Non-cardiac chest pain 1/82 (1.2%) 0/38 (0%)
    Hepatobiliary disorders
    Hyperbilirubinaemia 1/82 (1.2%) 1/38 (2.6%)
    Infections and infestations
    Sinusitis 4/82 (4.9%) 1/38 (2.6%)
    Cellulitis 3/82 (3.7%) 1/38 (2.6%)
    Candida infection 3/82 (3.7%) 0/38 (0%)
    Conjunctivitis 0/82 (0%) 2/38 (5.3%)
    Herpes zoster 1/82 (1.2%) 1/38 (2.6%)
    Hordeolum 2/82 (2.4%) 0/38 (0%)
    Influenza 1/82 (1.2%) 1/38 (2.6%)
    Subcutaneous abscess 2/82 (2.4%) 0/38 (0%)
    Urinary tract infection 2/82 (2.4%) 0/38 (0%)
    Carbuncle 0/82 (0%) 1/38 (2.6%)
    Ear infection 1/82 (1.2%) 0/38 (0%)
    Fungal skin infection 1/82 (1.2%) 0/38 (0%)
    Furuncle 1/82 (1.2%) 0/38 (0%)
    Helicobacter gastritis 1/82 (1.2%) 0/38 (0%)
    Herpes simplex 1/82 (1.2%) 0/38 (0%)
    Localised infection 1/82 (1.2%) 0/38 (0%)
    Nasopharyngitis 1/82 (1.2%) 0/38 (0%)
    Oral candidiasis 1/82 (1.2%) 0/38 (0%)
    Otitis externa 1/82 (1.2%) 0/38 (0%)
    Pneumonia 1/82 (1.2%) 0/38 (0%)
    Staphylococcal abscess 1/82 (1.2%) 0/38 (0%)
    Tinea cruris 0/82 (0%) 1/38 (2.6%)
    Tinea infection 0/82 (0%) 1/38 (2.6%)
    Upper respiratory tract infection 0/82 (0%) 1/38 (2.6%)
    Vulvovaginal candidiasis 1/82 (1.2%) 0/38 (0%)
    Vulvovaginal mycotic infection 1/82 (1.2%) 0/38 (0%)
    Injury, poisoning and procedural complications
    Muscle strain 1/82 (1.2%) 2/38 (5.3%)
    Ankle fracture 1/82 (1.2%) 0/38 (0%)
    Arthropod bite 1/82 (1.2%) 0/38 (0%)
    Laceration 1/82 (1.2%) 0/38 (0%)
    Thermal burn 1/82 (1.2%) 0/38 (0%)
    Tooth fracture 1/82 (1.2%) 0/38 (0%)
    Upper limb fracture 1/82 (1.2%) 0/38 (0%)
    Investigations
    Weight decreased 2/82 (2.4%) 2/38 (5.3%)
    Blood creatinine increased 1/82 (1.2%) 1/38 (2.6%)
    Cardiac murmur 1/82 (1.2%) 1/38 (2.6%)
    Platelet count decreased 2/82 (2.4%) 0/38 (0%)
    Amylase increased 1/82 (1.2%) 0/38 (0%)
    Blood thyroid stimulating hormone decreased 0/82 (0%) 1/38 (2.6%)
    Blood uric acid increased 1/82 (1.2%) 0/38 (0%)
    Blood urine present 1/82 (1.2%) 0/38 (0%)
    Haemoglobin decreased 1/82 (1.2%) 0/38 (0%)
    Hepatic enzyme increased 0/82 (0%) 1/38 (2.6%)
    Lipase increased 1/82 (1.2%) 0/38 (0%)
    Metabolism and nutrition disorders
    Decreased appetite 11/82 (13.4%) 7/38 (18.4%)
    Hyperuricaemia 8/82 (9.8%) 3/38 (7.9%)
    Hypokalaemia 6/82 (7.3%) 1/38 (2.6%)
    Dehydration 2/82 (2.4%) 0/38 (0%)
    Gout 0/82 (0%) 1/38 (2.6%)
    Hyperglycaemia 0/82 (0%) 1/38 (2.6%)
    Hypoglycaemia 0/82 (0%) 1/38 (2.6%)
    Musculoskeletal and connective tissue disorders
    Back pain 10/82 (12.2%) 4/38 (10.5%)
    Arthralgia 3/82 (3.7%) 7/38 (18.4%)
    Pain in extremity 8/82 (9.8%) 1/38 (2.6%)
    Myalgia 5/82 (6.1%) 3/38 (7.9%)
    Muscle spasms 4/82 (4.9%) 2/38 (5.3%)
    Neck pain 3/82 (3.7%) 1/38 (2.6%)
    Flank pain 2/82 (2.4%) 0/38 (0%)
    Dupuytren's contracture 1/82 (1.2%) 0/38 (0%)
    Groin pain 0/82 (0%) 1/38 (2.6%)
    Joint range of motion decreased 1/82 (1.2%) 0/38 (0%)
    Joint stiffness 0/82 (0%) 1/38 (2.6%)
    Muscular weakness 1/82 (1.2%) 0/38 (0%)
    Musculoskeletal discomfort 1/82 (1.2%) 0/38 (0%)
    Musculoskeletal pain 1/82 (1.2%) 0/38 (0%)
    Musculoskeletal stiffness 1/82 (1.2%) 0/38 (0%)
    Pain in jaw 1/82 (1.2%) 0/38 (0%)
    Spinal osteoarthritis 0/82 (0%) 1/38 (2.6%)
    Vertebral foraminal stenosis 0/82 (0%) 1/38 (2.6%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Invasive ductal breast carcinoma 1/82 (1.2%) 0/38 (0%)
    Lipoma 1/82 (1.2%) 0/38 (0%)
    Skin papilloma 1/82 (1.2%) 0/38 (0%)
    Transitional cell cancer of the renal pelvis and ureter 1/82 (1.2%) 0/38 (0%)
    Uterine leiomyoma 1/82 (1.2%) 0/38 (0%)
    Nervous system disorders
    Headache 14/82 (17.1%) 13/38 (34.2%)
    Dizziness 7/82 (8.5%) 8/38 (21.1%)
    Dysgeusia 4/82 (4.9%) 3/38 (7.9%)
    Disturbance in attention 2/82 (2.4%) 2/38 (5.3%)
    Hypoaesthesia 3/82 (3.7%) 1/38 (2.6%)
    Paraesthesia 3/82 (3.7%) 0/38 (0%)
    Burning sensation 1/82 (1.2%) 0/38 (0%)
    Lethargy 0/82 (0%) 1/38 (2.6%)
    Neuropathy peripheral 1/82 (1.2%) 0/38 (0%)
    Presyncope 0/82 (0%) 1/38 (2.6%)
    Sinus headache 1/82 (1.2%) 0/38 (0%)
    Syncope 1/82 (1.2%) 0/38 (0%)
    Tension headache 0/82 (0%) 1/38 (2.6%)
    Tremor 0/82 (0%) 1/38 (2.6%)
    Psychiatric disorders
    Insomnia 8/82 (9.8%) 10/38 (26.3%)
    Depression 8/82 (9.8%) 4/38 (10.5%)
    Irritability 6/82 (7.3%) 4/38 (10.5%)
    Anxiety 4/82 (4.9%) 2/38 (5.3%)
    Sleep disorder 1/82 (1.2%) 3/38 (7.9%)
    Mood swings 1/82 (1.2%) 1/38 (2.6%)
    Alcoholism 0/82 (0%) 1/38 (2.6%)
    Confusional state 1/82 (1.2%) 0/38 (0%)
    Hallucination 0/82 (0%) 1/38 (2.6%)
    Initial insomnia 0/82 (0%) 1/38 (2.6%)
    Panic attack 0/82 (0%) 1/38 (2.6%)
    Restlessness 0/82 (0%) 1/38 (2.6%)
    Stress 1/82 (1.2%) 0/38 (0%)
    Renal and urinary disorders
    Haematuria 2/82 (2.4%) 0/38 (0%)
    Dysuria 1/82 (1.2%) 0/38 (0%)
    Nephrolithiasis 1/82 (1.2%) 0/38 (0%)
    Renal failure 0/82 (0%) 1/38 (2.6%)
    Renal pain 0/82 (0%) 1/38 (2.6%)
    Reproductive system and breast disorders
    Erectile dysfunction 3/82 (3.7%) 1/38 (2.6%)
    Dyspareunia 1/82 (1.2%) 0/38 (0%)
    Genital rash 1/82 (1.2%) 0/38 (0%)
    Penile discharge 1/82 (1.2%) 0/38 (0%)
    Penis disorder 1/82 (1.2%) 0/38 (0%)
    Vaginal haemorrhage 1/82 (1.2%) 0/38 (0%)
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 11/82 (13.4%) 4/38 (10.5%)
    Cough 7/82 (8.5%) 1/38 (2.6%)
    Dyspnoea exertional 2/82 (2.4%) 0/38 (0%)
    Oropharyngeal pain 1/82 (1.2%) 1/38 (2.6%)
    Sinus congestion 2/82 (2.4%) 0/38 (0%)
    Epistaxis 0/82 (0%) 1/38 (2.6%)
    Increased upper airway secretion 0/82 (0%) 1/38 (2.6%)
    Nasal congestion 0/82 (0%) 1/38 (2.6%)
    Nasal mucosal disorder 1/82 (1.2%) 0/38 (0%)
    Productive cough 1/82 (1.2%) 0/38 (0%)
    Upper-airway cough syndrome 1/82 (1.2%) 0/38 (0%)
    Skin and subcutaneous tissue disorders
    Pruritus 33/82 (40.2%) 16/38 (42.1%)
    Rash 15/82 (18.3%) 13/38 (34.2%)
    Alopecia 6/82 (7.3%) 2/38 (5.3%)
    Dry skin 6/82 (7.3%) 2/38 (5.3%)
    Drug eruption 5/82 (6.1%) 1/38 (2.6%)
    Pruritus generalised 5/82 (6.1%) 1/38 (2.6%)
    Skin discolouration 2/82 (2.4%) 0/38 (0%)
    Skin fissures 2/82 (2.4%) 0/38 (0%)
    Dermatitis 1/82 (1.2%) 0/38 (0%)
    Dermatitis atopic 0/82 (0%) 1/38 (2.6%)
    Drug reaction with eosinophilia and systemic symptoms 0/82 (0%) 1/38 (2.6%)
    Erythema 0/82 (0%) 1/38 (2.6%)
    Hyperhidrosis 0/82 (0%) 1/38 (2.6%)
    Ingrowing nail 0/82 (0%) 1/38 (2.6%)
    Lichen planus 1/82 (1.2%) 0/38 (0%)
    Neurodermatitis 1/82 (1.2%) 0/38 (0%)
    Photosensitivity reaction 0/82 (0%) 1/38 (2.6%)
    Pigmentation disorder 1/82 (1.2%) 0/38 (0%)
    Psoriasis 1/82 (1.2%) 0/38 (0%)
    Rash maculo-papular 1/82 (1.2%) 0/38 (0%)
    Rash papular 0/82 (0%) 1/38 (2.6%)
    Rash pruritic 1/82 (1.2%) 0/38 (0%)
    Rosacea 0/82 (0%) 1/38 (2.6%)
    Skin hyperpigmentation 1/82 (1.2%) 0/38 (0%)
    Urticaria 0/82 (0%) 1/38 (2.6%)
    Vascular disorders
    Hypertension 4/82 (4.9%) 0/38 (0%)
    Flushing 0/82 (0%) 1/38 (2.6%)
    Orthostatic hypotension 1/82 (1.2%) 0/38 (0%)
    Pallor 0/82 (0%) 1/38 (2.6%)

    Limitations/Caveats

    It was decided by Sponsor on 13 January 2014 to terminate the study early as part of a decision to modify the drug development plan. Eligible participants completed virologic follow-up after termination.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    PI is free to publish results of the study after (1) the first multi-center publication, (2) if the sponsor elects not to publish the results, or (3) 18 months after close of the study, whichever occurs first. Proposed publications are to be submitted to the sponsor for review and comment for a period of at least 45 days (which may be extended under certain circumstances related to protection of intellectual property); the sponsor cannot require changes to the proposed publications.

    Results Point of Contact

    Name/Title Medical Monitor
    Organization Vertex Pharmaceuticals Incorporated
    Phone 617-341-6777
    Email medicalinfo@vrtx.com
    Responsible Party:
    Vertex Pharmaceuticals Incorporated
    ClinicalTrials.gov Identifier:
    NCT01467492
    Other Study ID Numbers:
    • VX11-950-116
    First Posted:
    Nov 8, 2011
    Last Update Posted:
    Aug 3, 2015
    Last Verified:
    Jun 1, 2015