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Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha and Ribavirin)

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT00874770
Collaborator
(none)
74
Enrollment
14
Locations
4
Arms
19
Duration (Months)
5.3
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to identify 1 or more doses of daclatasvir, which when used in combination with pegylated interferon alpha and ribavirin, are safe and demonstrate sufficient anti-hepatitis C virus activity.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
74 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2a Study of BMS-790052 in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment Naive Subjects With Chronic Hepatitis C Virus Genotype 1
Study Start Date :
Jun 1, 2009
Actual Primary Completion Date :
Nov 1, 2009
Actual Study Completion Date :
Jan 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Daclatasvir, plus Peginterferon alpha-2a, ribavirin (A)

Active Comparator

Drug: Daclatasvir
Tablets, oral, 3 mg, Daily, 48 weeks

Drug: Peginterferon alpha-2a
Syringe, subcutaneous, 180 µg, Weekly, 48 weeks
Other Names:
  • Pegasys

    • Drug: ribavirin
    Tablet, oral, 1000 or 1200 mg, based on weight, Daily, 48 weeks
    Other Names:
  • Copegus

    		•
    Experimental: Daclatasvir, Peginterferon alpha-2a, ribavirin (B)

    Active Comparator

    Drug: Daclatasvir
    Tablets, oral, 10 mg, Daily, 48 weeks

    Drug: Peginterferon alpha-2a
    Syringe, subcutaneous, 180 µg, Weekly, 48 weeks
    Other Names:
  • Pegasys

    • Drug: ribavirin
    Tablet, oral, 1000 or 1200 mg, based on weight, Daily, 48 weeks
    Other Names:
  • Copegus

    		•
    Experimental: Daclatasvir, Peginterferon alpha-2a, ribavirin (C)

    Active Comparator

    Drug: Daclatasvir
    Tablets, oral, 60 mg, Daily, 48 weeks

    Drug: Peginterferon alpha-2a
    Syringe, subcutaneous, 180 µg, Weekly, 48 weeks
    Other Names:
  • Pegasys

    • Drug: ribavirin
    Tablet, oral, 1000 or 1200 mg, based on weight, Daily, 48 weeks
    Other Names:
  • Copegus

    		•
    Active Comparator: Placebo, Peginterferon alpha-2a, ribavirin (D)

    Drug: Placebo
    Tablet, oral, 0 mg, Daily 48 weeks

    Drug: Peginterferon alpha-2a
    Syringe, subcutaneous, 180 µg, Weekly, 48 weeks
    Other Names:
  • Pegasys

    • Drug: ribavirin
    Tablet, oral, 1000 or 1200 mg, based on weight, Daily, 48 weeks
    Other Names:
  • Copegus

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12 [A Weeks 4 and 12]

      eRVR was defined as undetectable hepatitis C virus RNA less than the lower limit of detection (10 IU/mL) at Weeks 4 and 12.

    Secondary Outcome Measures

    1. Percentage of Participants With Rapid Virologic Response (RVR) at Week 4 [At Week 4]

      RVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA less than the lower limit of detection (10 IU/mL) at Week 4.

    2. Percentage of Participants With Early Virologic Response (EVR) at Week 12 [At Week 12]

      EVR was defined as a ≥2 log10 decrease in hepatitis C virus (HCV) RNA from baseline at Week 12 , or HCV RNA <10 IU/mL for participants with baseline HCV RNA <1000 IU/mL.

    3. Percentage of Participants With a Complete Early Virologic Response (cEVR) at Week 12 [At Week 12]

      cEVR was defined as hepatitis C virus RNA <10 IU/mL at Week 12

    Other Outcome Measures

    1. Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Treatment Phase [SAE: From Day 1 up to 30 days after last dose of study drug, AE: From Day 1 to 7 days after last dose of study drug]

      An AE was defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a patient or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug.

    2. Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Follow-up Period [From Day 31 up to Week 24 of post treatment follow-up]

      An AE was defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a patient or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug.

    3. Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results [From screening up to Week 12 (treatment period)]

      Clinically significant change in marked laboratory abnormalities (Grade 3 to 4 ) included: Alanine aminotransferase (ALT)- Grade 3 as >5.0 to 10.0* Upper Limit of Normal (ULN), Grade 4 as >10.0*ULN; Aspartate aminotransferase (AST)- Grade 3 as >5.0 to 10.0*ULN, Grade 4 as >10.0*ULN; Hemoglobin- Grade 3 as 7.0 to 8.9 g/dL, Grade 4 as <7.0 g/dL; Neutrophils- Grade 3 as 0.5 to 0.749*10^9/L, Grade 4 as <0.5*10^9/L; Lymphocytes- Grade 3 as 0.35 to 0.499*10^9/L, Grade 4 as <0.35*10^9/L; Total Bilirubin- Grade 3 as 2.6-5.0*ULN, Grade 4 as >5.0*ULN; Platelets- Grade 3 as 25000 to 49999*10^9/L, Grade 4 as <25000 10^9/L and white blood cells (WBC) - Grade 3 as 1000 to 1499*10^9/L, Grade 4 as <1000*10^9/L.

    Eligibility Criteria

    Criteria

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

    • Patients chronically infected with hepatitis C virus (HCV) genotype 1

    • HCV RNA viral load of ≥105 IU/mL (100,000 IU/mL) at screening

    • Treatment naive

    Key Exclusion Criteria:

    • Women of child-bearing potential

    • Cirrhosis

    • Coinfection with HIV or hepatitis B virus

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alabama Liver & Digestive Specialists (Alds) Montgomery Alabama United States 36116
    2 University Of Colorado Denver & Hospital Aurora Colorado United States 80045
    3 Yale University School Of Medicine New Haven Connecticut United States 06520
    4 Mercy Medical Center Baltimore Maryland United States 21202
    5 Llc Dba The Research Institute Springfield Massachusetts United States 01107
    6 Veterans Affairs Medical Center Bronx New York United States 10468
    7 Carolinas Center For Liver Disease Statesville North Carolina United States 28677
    8 Options Health Research, Llc Tulsa Oklahoma United States 74104
    9 Healthcare Research Consultants Tulsa Oklahoma United States 74135
    10 North Texas Research Institute Arlington Texas United States 76012
    11 Metropolitan Research Fairfax Virginia United States 22031
    12 Local Institution Creteil France 94010
    13 Local Institution Paris Cedex 14 France 75679
    14 Local Institution Vandoeuvre Les Nancy France 54511

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT00874770
    Other Study ID Numbers:
    • AI444-014
    • EUDRACT# 2009-010149-29
    First Posted:
    Apr 3, 2009
    Last Update Posted:
    Oct 23, 2015
    Last Verified:
    Sep 1, 2015
    Keywords provided by Bristol-Myers Squibb
    Antivirals
    Additional relevant MeSH terms:
    Hepatitis C
    Hepatitis
    Ribavirin
    Peginterferon alfa-2a

    Study Results

    Participant Flow

    Recruitment Details The study was conducted at 14 sites in France and USA.
    Pre-assignment Detail A total of 74 participants were enrolled, of which 48 were randomized to receive treatment and 26 were not randomized: 22 no longer met study criteria, 2 withdrew consent, 1 was lost to follow-up, and 1 due to other reasons.
    Arm/Group Title Daclatasvir 3 mg + pegIFNα-2a + Ribavirin Daclatasvir 10 mg + pegIFNα-2a + Ribavirin Daclatasvir 60 mg + pegIFNα-2a + Ribavirin Placebo+pegIFNα-2a+Ribavirin
    Arm/Group Description Participants received 3 mg of daclatasvir once daily (OD) in coadministration with peginterferon alpha-2a (pegIFNα-2a)180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). Participants received 10 mg of daclatasvir OD coadministered with pegIFNα-2a 180 µg given subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). Participants received 60 mg of daclatasvir OD in coadministration with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). Participants received a matching placebo of daclatasvir tablets administered orally once daily for 48 weeks in coadministration with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
    Period Title: Overall Study
    STARTED 12 12 12 12
    COMPLETED 7 11 8 7
    NOT COMPLETED 5 1 4 5

    Baseline Characteristics

    Arm/Group Title Daclatasvir 3-mg+pegIFNα-2a-2a+Ribavirin Daclatasvir 10-mg+pegIFNα-2a+Ribavirin Daclatasvir 60-mg+pegIFNα-2a+Ribavirin Placebo+pegIFNα-2a+Ribavirin Total
    Arm/Group Description Participants received 3 mg of daclatasvir once daily (OD) in coadministration with peginterferon alpha-2a (pegIFNα-2a)180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). Participants received 10-mg of daclatasvir OD in coadministration with pegIFNα-2a-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). Participants received 60-mg of daclatasvir OD in coadministration with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). Participants received a matching placebo of daclatasvir tablets administered orally once daily for 48 weeks in coadministration with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). Total of all reporting groups
    Overall Participants 12 12 12 12 48
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    52
    (8.56)
    53.2
    (9.11)
    52
    (7.34)
    48
    (10.20)
    51.3
    (8.80)
    Sex: Female, Male (Count of Participants)
    Female
    3
    25%
    4
    33.3%
    5
    41.7%
    4
    33.3%
    16
    33.3%
    Male
    9
    75%
    8
    66.7%
    7
    58.3%
    8
    66.7%
    32
    66.7%

    Outcome Measures

    1. Other Pre-specified Outcome
    Title Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Treatment Phase
    Description An AE was defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a patient or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug.
    Time Frame SAE: From Day 1 up to 30 days after last dose of study drug, AE: From Day 1 to 7 days after last dose of study drug

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of study drug.
    Arm/Group Title Daclatasvir 3 mg + pegIFNα-2a + Ribavirin Daclatasvir 10 mg + pegIFNα-2a + Ribavirin Daclatasvir 60 mg + pegIFNα-2a + Ribavirin Placebo + pegIFNα-2a + Ribavirin
    Arm/Group Description Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). Participants received 10 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
    Measure Participants 12 12 12 12
    SAEs
    1
    8.3%
    1
    8.3%
    1
    8.3%
    0
    0%
    Discontinuation due to AEs
    1
    8.3%
    1
    8.3%
    4
    33.3%
    2
    16.7%
    Grade 2 to 4 Related AEs
    6
    50%
    6
    50%
    9
    75%
    7
    58.3%
    Deaths
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2. Other Pre-specified Outcome
    Title Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Follow-up Period
    Description An AE was defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a patient or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug.
    Time Frame From Day 31 up to Week 24 of post treatment follow-up

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of study drug. n=evaluable patients
    Arm/Group Title Daclatasvir 3 mg + pegIFNα-2a + Rribavirin Daclatasvir 10 mg + pegIFNα-2a + Ribavirin Daclatasvir 60 mg + pegIFNα-2a + Ribavirin Placebo + pegIFNα-2a + Ribavirin
    Arm/Group Description Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). Participants received 10 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
    Measure Participants 12 12 12 12
    SAEs (n=10,12,12,10)
    0
    0%
    0
    0%
    3
    25%
    0
    0%
    Discontinuation due to AEs
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Grade 2 to 4 Related AEs
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Deaths
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    3. Primary Outcome
    Title Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12
    Description eRVR was defined as undetectable hepatitis C virus RNA less than the lower limit of detection (10 IU/mL) at Weeks 4 and 12.
    Time Frame A Weeks 4 and 12

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of study drug.
    Arm/Group Title Daclatasvir 3 mg + pegIFNα-2a + Ribavirin Daclatasvir 10 mg + pegIFNα-2a + Ribavirin Daclatasvir 60 mg + pegIFNα-2a + Ribavirin Placebo + pegIFNα-2a + Ribavirin
    Arm/Group Description Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). Participants received 10 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). Participants received 60 mg of daclatasvir OD in coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
    Measure Participants 12 12 12 12
    Number [percentage of participants]
    41.7
    347.5%
    83.3
    694.2%
    75
    625%
    8.3
    69.2%
    4. Secondary Outcome
    Title Percentage of Participants With Rapid Virologic Response (RVR) at Week 4
    Description RVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA less than the lower limit of detection (10 IU/mL) at Week 4.
    Time Frame At Week 4

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of study drug.
    Arm/Group Title Daclatasvir 3 mg + pegIFNα-2a + Ribavirin Daclatasvir 10 mg + pegIFNα-2a + Ribavirin Daclatasvir 60 mg + pegIFNα-2a + Ribavirin Placebo + pegIFNα-2a + Ribavirin
    Arm/Group Description Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). Participants received 10-mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weekswith pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
    Measure Participants 12 12 12 12
    Number [percentage of participants]
    41.7
    347.5%
    91.7
    764.2%
    83.3
    694.2%
    8.3
    69.2%
    5. Secondary Outcome
    Title Percentage of Participants With Early Virologic Response (EVR) at Week 12
    Description EVR was defined as a ≥2 log10 decrease in hepatitis C virus (HCV) RNA from baseline at Week 12 , or HCV RNA <10 IU/mL for participants with baseline HCV RNA <1000 IU/mL.
    Time Frame At Week 12

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of study drug.
    Arm/Group Title Daclatasvir 3 mg + pegIFNα-2a + Ribavirin Daclatasvir 10 mg + pegIFNα-2a + Ribavirin Daclatasvir 60 mg + pegIFNα-2a + Ribavirin Placebo + pegIFNα-2a + Ribavirin
    Arm/Group Description Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). Participants received 10 mg of daclatasvir OD in coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
    Measure Participants 12 12 12 12
    Number [percentage of participants]
    75
    625%
    100
    833.3%
    83.3
    694.2%
    66.7
    555.8%
    6. Secondary Outcome
    Title Percentage of Participants With a Complete Early Virologic Response (cEVR) at Week 12
    Description cEVR was defined as hepatitis C virus RNA <10 IU/mL at Week 12
    Time Frame At Week 12

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of study drug.
    Arm/Group Title Daclatasvir 3 mg + pegIFNα-2a + Riibavirin Daclatasvir 10 mg + pegIFNα-2a + Ribavirin Daclatasvir 60 mg + pegIFNα-2a + Ribavirin Placebo + pegIFNα-2a + Ribavirin
    Arm/Group Description Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). Participants received 10 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).48 weeks.
    Measure Participants 12 12 12 12
    Number [percentage of participants]
    58.3
    485.8%
    83.3
    694.2%
    83.3
    694.2%
    41.7
    347.5%
    7. Other Pre-specified Outcome
    Title Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results
    Description Clinically significant change in marked laboratory abnormalities (Grade 3 to 4 ) included: Alanine aminotransferase (ALT)- Grade 3 as >5.0 to 10.0* Upper Limit of Normal (ULN), Grade 4 as >10.0*ULN; Aspartate aminotransferase (AST)- Grade 3 as >5.0 to 10.0*ULN, Grade 4 as >10.0*ULN; Hemoglobin- Grade 3 as 7.0 to 8.9 g/dL, Grade 4 as <7.0 g/dL; Neutrophils- Grade 3 as 0.5 to 0.749*10^9/L, Grade 4 as <0.5*10^9/L; Lymphocytes- Grade 3 as 0.35 to 0.499*10^9/L, Grade 4 as <0.35*10^9/L; Total Bilirubin- Grade 3 as 2.6-5.0*ULN, Grade 4 as >5.0*ULN; Platelets- Grade 3 as 25000 to 49999*10^9/L, Grade 4 as <25000 10^9/L and white blood cells (WBC) - Grade 3 as 1000 to 1499*10^9/L, Grade 4 as <1000*10^9/L.
    Time Frame From screening up to Week 12 (treatment period)

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of study drug. n=evaluable patients at the specified time point
    Arm/Group Title Daclatasvir 3 mg + pegIFNα-2a + Ribavirin Daclatasvir 10 mg + pegIFNα-2a + Ribavirin Daclatasvir 60 mg + pegIFNα-2a + Ribavirin Placebo + pegIFNα-2a + Ribavirin
    Arm/Group Description Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). Participants received 10 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). Participants received a matching placebo of daclatasvir tablets once daily for 48 weeks coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
    Measure Participants 12 12 12 12
    Hemoglobin (n= 11,12,12,11)
    1
    8.3%
    0
    0%
    1
    8.3%
    0
    0%
    Lymphocytes (n= 11,12,12,12)
    1
    8.3%
    3
    25%
    3
    25%
    3
    25%
    Neutrophils (n= 11,12,12,12)
    2
    16.7%
    4
    33.3%
    3
    25%
    4
    33.3%
    Platelets (n= 11,12,12,12)
    0
    0%
    0
    0%
    0
    0%
    1
    8.3%
    ALT (n= 11,12,12,12)
    0
    0%
    1
    8.3%
    0
    0%
    3
    25%
    AST (n= 11,12,12,12)
    0
    0%
    0
    0%
    0
    0%
    3
    25%
    Total bilirubin (n= 11,12,12,12)
    0
    0%
    0
    0%
    1
    8.3%
    0
    0%
    WBC (n= 11, 12, 12, 12)
    0
    0%
    2
    16.7%
    1
    8.3%
    2
    16.7%

    Adverse Events

    Time Frame From baseline to 30 days after last dose of drug
    Adverse Event Reporting Description
    Arm/Group Title Daclatasvir 3 mg + pegIFNα-2a + Ribavirin Daclatasvir 10 mg + pegIFNα-2a + Ribavirin Daclatasvir 60 mg + pegIFNα-2a + Ribavirin Placebo + pegIFNα-2a + Ribavirin
    Arm/Group Description Participants received 3 mg of daclatasvir once daily (OD) in coadministration orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). Participants received 10 mg of daclatasvir OD in coadministration orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). Participants received 60 mg of daclatasvir OD in coadministration orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks). Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks in with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
    All Cause Mortality
    Daclatasvir 3 mg + pegIFNα-2a + Ribavirin Daclatasvir 10 mg + pegIFNα-2a + Ribavirin Daclatasvir 60 mg + pegIFNα-2a + Ribavirin Placebo + pegIFNα-2a + Ribavirin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Daclatasvir 3 mg + pegIFNα-2a + Ribavirin Daclatasvir 10 mg + pegIFNα-2a + Ribavirin Daclatasvir 60 mg + pegIFNα-2a + Ribavirin Placebo + pegIFNα-2a + Ribavirin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/12 (8.3%) 1/12 (8.3%) 1/12 (8.3%) 0/12 (0%)
    Blood and lymphatic system disorders
    Anaemia 0/12 (0%) 1/12 (8.3%) 0/12 (0%) 0/12 (0%)
    General disorders
    Chest pain 0/12 (0%) 1/12 (8.3%) 0/12 (0%) 0/12 (0%)
    Infections and infestations
    Bronchitis 0/12 (0%) 0/12 (0%) 1/12 (8.3%) 0/12 (0%)
    Nervous system disorders
    Syncope 1/12 (8.3%) 1/12 (8.3%) 0/12 (0%) 0/12 (0%)
    Respiratory, thoracic and mediastinal disorders
    Epistaxis 0/12 (0%) 1/12 (8.3%) 0/12 (0%) 0/12 (0%)
    Other (Not Including Serious) Adverse Events
    Daclatasvir 3 mg + pegIFNα-2a + Ribavirin Daclatasvir 10 mg + pegIFNα-2a + Ribavirin Daclatasvir 60 mg + pegIFNα-2a + Ribavirin Placebo + pegIFNα-2a + Ribavirin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 12/12 (100%) 12/12 (100%) 12/12 (100%) 12/12 (100%)
    Blood and lymphatic system disorders
    Lymphadenopathy 1/12 (8.3%) 0/12 (0%) 0/12 (0%) 0/12 (0%)
    Thrombocytopenia 0/12 (0%) 1/12 (8.3%) 1/12 (8.3%) 1/12 (8.3%)
    Neutropenia 4/12 (33.3%) 3/12 (25%) 2/12 (16.7%) 5/12 (41.7%)
    Anaemia 5/12 (41.7%) 3/12 (25%) 6/12 (50%) 5/12 (41.7%)
    Lymphopenia 0/12 (0%) 0/12 (0%) 2/12 (16.7%) 0/12 (0%)
    Cardiac disorders
    Tachycardia 0/12 (0%) 0/12 (0%) 1/12 (8.3%) 0/12 (0%)
    Ear and labyrinth disorders
    Vertigo 0/12 (0%) 1/12 (8.3%) 1/12 (8.3%) 0/12 (0%)
    Eye disorders
    Ocular hyperaemia 0/12 (0%) 0/12 (0%) 0/12 (0%) 1/12 (8.3%)
    Vision blurred 2/12 (16.7%) 0/12 (0%) 0/12 (0%) 0/12 (0%)
    Dry eye 1/12 (8.3%) 1/12 (8.3%) 0/12 (0%) 0/12 (0%)
    Gastrointestinal disorders
    Abdominal pain upper 0/12 (0%) 1/12 (8.3%) 1/12 (8.3%) 1/12 (8.3%)
    Dry mouth 0/12 (0%) 2/12 (16.7%) 1/12 (8.3%) 1/12 (8.3%)
    Gingival pain 0/12 (0%) 0/12 (0%) 1/12 (8.3%) 0/12 (0%)
    Abdominal tenderness 1/12 (8.3%) 0/12 (0%) 0/12 (0%) 0/12 (0%)
    Dyspepsia 1/12 (8.3%) 1/12 (8.3%) 0/12 (0%) 0/12 (0%)
    Proctalgia 0/12 (0%) 1/12 (8.3%) 0/12 (0%) 0/12 (0%)
    Abdominal pain 0/12 (0%) 0/12 (0%) 0/12 (0%) 1/12 (8.3%)
    Cheilitis 1/12 (8.3%) 0/12 (0%) 0/12 (0%) 0/12 (0%)
    Gastrooesophageal reflux disease 3/12 (25%) 1/12 (8.3%) 0/12 (0%) 0/12 (0%)
    Hyperchlorhydria 0/12 (0%) 1/12 (8.3%) 0/12 (0%) 0/12 (0%)
    Vomiting 1/12 (8.3%) 2/12 (16.7%) 4/12 (33.3%) 0/12 (0%)
    Flatulence 0/12 (0%) 1/12 (8.3%) 0/12 (0%) 0/12 (0%)
    Periodontal disease 0/12 (0%) 0/12 (0%) 0/12 (0%) 1/12 (8.3%)
    Stomatitis 1/12 (8.3%) 0/12 (0%) 1/12 (8.3%) 0/12 (0%)
    Gingival disorder 0/12 (0%) 0/12 (0%) 1/12 (8.3%) 0/12 (0%)
    Abdominal pain lower 0/12 (0%) 0/12 (0%) 1/12 (8.3%) 0/12 (0%)
    Tongue ulceration 0/12 (0%) 0/12 (0%) 0/12 (0%) 1/12 (8.3%)
    Dental caries 0/12 (0%) 0/12 (0%) 1/12 (8.3%) 0/12 (0%)
    Diarrhoea 1/12 (8.3%) 3/12 (25%) 1/12 (8.3%) 3/12 (25%)
    Gingival hypertrophy 1/12 (8.3%) 0/12 (0%) 0/12 (0%) 0/12 (0%)
    Nausea 4/12 (33.3%) 5/12 (41.7%) 4/12 (33.3%) 6/12 (50%)
    General disorders
    Injection site reaction 1/12 (8.3%) 1/12 (8.3%) 0/12 (0%) 1/12 (8.3%)
    Injection site erythema 0/12 (0%) 1/12 (8.3%) 1/12 (8.3%) 0/12 (0%)
    Irritability 3/12 (25%) 6/12 (50%) 3/12 (25%) 2/12 (16.7%)
    Asthenia 3/12 (25%) 1/12 (8.3%) 5/12 (41.7%) 1/12 (8.3%)
    Injection site pain 0/12 (0%) 0/12 (0%) 0/12 (0%) 1/12 (8.3%)
    Fatigue 6/12 (50%) 7/12 (58.3%) 6/12 (50%) 9/12 (75%)
    Influenza like illness 3/12 (25%) 6/12 (50%) 2/12 (16.7%) 4/12 (33.3%)
    Injection site irritation 0/12 (0%) 1/12 (8.3%) 0/12 (0%) 0/12 (0%)
    Malaise 0/12 (0%) 0/12 (0%) 1/12 (8.3%) 0/12 (0%)
    Chills 2/12 (16.7%) 1/12 (8.3%) 1/12 (8.3%) 2/12 (16.7%)
    Injection site pruritus 0/12 (0%) 0/12 (0%) 0/12 (0%) 1/12 (8.3%)
    Pyrexia 1/12 (8.3%) 3/12 (25%) 3/12 (25%) 3/12 (25%)
    Chest pain 0/12 (0%) 1/12 (8.3%) 1/12 (8.3%) 0/12 (0%)
    Pain 3/12 (25%) 0/12 (0%) 2/12 (16.7%) 1/12 (8.3%)
    Hepatobiliary disorders
    Hypertransaminasaemia 0/12 (0%) 0/12 (0%) 0/12 (0%) 1/12 (8.3%)
    Infections and infestations
    Ear infection 0/12 (0%) 0/12 (0%) 1/12 (8.3%) 0/12 (0%)
    Genital herpes 1/12 (8.3%) 0/12 (0%) 0/12 (0%) 0/12 (0%)
    Carbuncle 0/12 (0%) 0/12 (0%) 0/12 (0%) 1/12 (8.3%)
    Oral herpes 1/12 (8.3%) 0/12 (0%) 0/12 (0%) 0/12 (0%)
    Upper respiratory tract infection 2/12 (16.7%) 0/12 (0%) 1/12 (8.3%) 1/12 (8.3%)
    Gastroenteritis 1/12 (8.3%) 0/12 (0%) 0/12 (0%) 0/12 (0%)
    Hordeolum 0/12 (0%) 0/12 (0%) 0/12 (0%) 1/12 (8.3%)
    Nasopharyngitis 0/12 (0%) 1/12 (8.3%) 1/12 (8.3%) 0/12 (0%)
    Oral candidiasis 0/12 (0%) 0/12 (0%) 1/12 (8.3%) 0/12 (0%)
    Gastrointestinal viral infection 0/12 (0%) 0/12 (0%) 0/12 (0%) 1/12 (8.3%)
    Herpes zoster 0/12 (0%) 0/12 (0%) 1/12 (8.3%) 0/12 (0%)
    Pharyngitis 0/12 (0%) 0/12 (0%) 0/12 (0%) 1/12 (8.3%)
    Tooth infection 0/12 (0%) 0/12 (0%) 1/12 (8.3%) 0/12 (0%)
    Body tinea 1/12 (8.3%) 0/12 (0%) 0/12 (0%) 0/12 (0%)
    Gastroenteritis viral 0/12 (0%) 0/12 (0%) 0/12 (0%) 1/12 (8.3%)
    Pneumonia 0/12 (0%) 1/12 (8.3%) 0/12 (0%) 0/12 (0%)
    Influenza 0/12 (0%) 0/12 (0%) 1/12 (8.3%) 0/12 (0%)
    Tooth abscess 1/12 (8.3%) 0/12 (0%) 0/12 (0%) 0/12 (0%)
    Bronchitis 1/12 (8.3%) 0/12 (0%) 0/12 (0%) 2/12 (16.7%)
    Osteomyelitis 0/12 (0%) 0/12 (0%) 0/12 (0%) 1/12 (8.3%)
    Sinusitis 0/12 (0%) 1/12 (8.3%) 2/12 (16.7%) 0/12 (0%)
    Wound infection 1/12 (8.3%) 0/12 (0%) 0/12 (0%) 0/12 (0%)
    Injury, poisoning and procedural complications
    Muscle strain 0/12 (0%) 0/12 (0%) 0/12 (0%) 1/12 (8.3%)
    Road traffic accident 1/12 (8.3%) 0/12 (0%) 0/12 (0%) 0/12 (0%)
    Arthropod bite 0/12 (0%) 0/12 (0%) 1/12 (8.3%) 0/12 (0%)
    Tooth fracture 0/12 (0%) 0/12 (0%) 1/12 (8.3%) 0/12 (0%)
    Lip injury 1/12 (8.3%) 0/12 (0%) 0/12 (0%) 0/12 (0%)
    Investigations
    Blood thyroid stimulating hormone increased 1/12 (8.3%) 0/12 (0%) 0/12 (0%) 0/12 (0%)
    Weight decreased 3/12 (25%) 1/12 (8.3%) 0/12 (0%) 2/12 (16.7%)
    Liver function test abnormal 0/12 (0%) 0/12 (0%) 0/12 (0%) 1/12 (8.3%)
    Electrocardiogram QT prolonged 0/12 (0%) 0/12 (0%) 1/12 (8.3%) 0/12 (0%)
    Prothrombin time prolonged 0/12 (0%) 0/12 (0%) 1/12 (8.3%) 0/12 (0%)
    Weight increased 0/12 (0%) 1/12 (8.3%) 0/12 (0%) 0/12 (0%)
    Metabolism and nutrition disorders
    Decreased appetite 2/12 (16.7%) 3/12 (25%) 4/12 (33.3%) 3/12 (25%)
    Musculoskeletal and connective tissue disorders
    Back pain 0/12 (0%) 2/12 (16.7%) 1/12 (8.3%) 2/12 (16.7%)
    Muscular weakness 1/12 (8.3%) 0/12 (0%) 0/12 (0%) 0/12 (0%)
    Arthralgia 1/12 (8.3%) 0/12 (0%) 1/12 (8.3%) 0/12 (0%)
    Muscle spasms 0/12 (0%) 0/12 (0%) 2/12 (16.7%) 0/12 (0%)
    Myalgia 3/12 (25%) 3/12 (25%) 2/12 (16.7%) 3/12 (25%)
    Pain in extremity 1/12 (8.3%) 2/12 (16.7%) 0/12 (0%) 0/12 (0%)
    Musculoskeletal chest pain 0/12 (0%) 0/12 (0%) 0/12 (0%) 1/12 (8.3%)
    Coccydynia 1/12 (8.3%) 0/12 (0%) 0/12 (0%) 0/12 (0%)
    Musculoskeletal pain 0/12 (0%) 0/12 (0%) 1/12 (8.3%) 0/12 (0%)
    Nervous system disorders
    Dysgeusia 1/12 (8.3%) 1/12 (8.3%) 0/12 (0%) 1/12 (8.3%)
    Cubital tunnel syndrome 0/12 (0%) 0/12 (0%) 1/12 (8.3%) 0/12 (0%)
    Disturbance in attention 0/12 (0%) 1/12 (8.3%) 1/12 (8.3%) 0/12 (0%)
    Tremor 2/12 (16.7%) 0/12 (0%) 0/12 (0%) 0/12 (0%)
    Dizziness 2/12 (16.7%) 1/12 (8.3%) 2/12 (16.7%) 1/12 (8.3%)
    Presyncope 1/12 (8.3%) 1/12 (8.3%) 0/12 (0%) 0/12 (0%)
    Syncope 1/12 (8.3%) 1/12 (8.3%) 0/12 (0%) 0/12 (0%)
    Burning sensation 0/12 (0%) 1/12 (8.3%) 0/12 (0%) 0/12 (0%)
    Paraesthesia 1/12 (8.3%) 0/12 (0%) 0/12 (0%) 0/12 (0%)
    Headache 9/12 (75%) 7/12 (58.3%) 3/12 (25%) 3/12 (25%)
    Hyperaesthesia 0/12 (0%) 1/12 (8.3%) 0/12 (0%) 0/12 (0%)
    Poor quality sleep 1/12 (8.3%) 0/12 (0%) 1/12 (8.3%) 1/12 (8.3%)
    Ageusia 0/12 (0%) 1/12 (8.3%) 0/12 (0%) 0/12 (0%)
    Dizziness postural 1/12 (8.3%) 0/12 (0%) 0/12 (0%) 0/12 (0%)
    Hypoaesthesia 0/12 (0%) 2/12 (16.7%) 1/12 (8.3%) 0/12 (0%)
    Sinus headache 1/12 (8.3%) 0/12 (0%) 0/12 (0%) 1/12 (8.3%)
    Psychiatric disorders
    Abnormal dreams 0/12 (0%) 0/12 (0%) 1/12 (8.3%) 0/12 (0%)
    Food aversion 0/12 (0%) 1/12 (8.3%) 0/12 (0%) 0/12 (0%)
    Hallucination, auditory 0/12 (0%) 1/12 (8.3%) 0/12 (0%) 0/12 (0%)
    Libido decreased 0/12 (0%) 0/12 (0%) 1/12 (8.3%) 1/12 (8.3%)
    Agitation 1/12 (8.3%) 0/12 (0%) 0/12 (0%) 0/12 (0%)
    Depressed mood 1/12 (8.3%) 1/12 (8.3%) 0/12 (0%) 0/12 (0%)
    Depression 2/12 (16.7%) 3/12 (25%) 2/12 (16.7%) 3/12 (25%)
    Insomnia 4/12 (33.3%) 4/12 (33.3%) 5/12 (41.7%) 6/12 (50%)
    Anxiety 1/12 (8.3%) 3/12 (25%) 2/12 (16.7%) 2/12 (16.7%)
    Mood swings 0/12 (0%) 1/12 (8.3%) 0/12 (0%) 1/12 (8.3%)
    Sleep disorder 0/12 (0%) 1/12 (8.3%) 0/12 (0%) 1/12 (8.3%)
    Renal and urinary disorders
    Dysuria 1/12 (8.3%) 0/12 (0%) 0/12 (0%) 0/12 (0%)
    Micturition urgency 0/12 (0%) 0/12 (0%) 1/12 (8.3%) 0/12 (0%)
    Reproductive system and breast disorders
    Erectile dysfunction 0/12 (0%) 0/12 (0%) 2/12 (16.7%) 0/12 (0%)
    Respiratory, thoracic and mediastinal disorders
    Dysphonia 0/12 (0%) 0/12 (0%) 0/12 (0%) 1/12 (8.3%)
    Dyspnoea exertional 1/12 (8.3%) 1/12 (8.3%) 1/12 (8.3%) 0/12 (0%)
    Sinus congestion 0/12 (0%) 0/12 (0%) 1/12 (8.3%) 0/12 (0%)
    Epistaxis 1/12 (8.3%) 2/12 (16.7%) 0/12 (0%) 0/12 (0%)
    Dyspnoea 2/12 (16.7%) 1/12 (8.3%) 3/12 (25%) 2/12 (16.7%)
    Nasal congestion 1/12 (8.3%) 0/12 (0%) 0/12 (0%) 1/12 (8.3%)
    Bronchitis chronic 0/12 (0%) 0/12 (0%) 1/12 (8.3%) 0/12 (0%)
    Respiratory tract congestion 0/12 (0%) 1/12 (8.3%) 1/12 (8.3%) 0/12 (0%)
    Wheezing 1/12 (8.3%) 0/12 (0%) 0/12 (0%) 0/12 (0%)
    Cough 5/12 (41.7%) 2/12 (16.7%) 2/12 (16.7%) 3/12 (25%)
    Oropharyngeal pain 1/12 (8.3%) 2/12 (16.7%) 1/12 (8.3%) 0/12 (0%)
    Rhinorrhoea 1/12 (8.3%) 0/12 (0%) 1/12 (8.3%) 0/12 (0%)
    Skin and subcutaneous tissue disorders
    Rash macular 0/12 (0%) 0/12 (0%) 1/12 (8.3%) 0/12 (0%)
    Toxic skin eruption 0/12 (0%) 0/12 (0%) 1/12 (8.3%) 0/12 (0%)
    Actinic keratosis 0/12 (0%) 0/12 (0%) 0/12 (0%) 1/12 (8.3%)
    Pain of skin 0/12 (0%) 0/12 (0%) 1/12 (8.3%) 0/12 (0%)
    Dry skin 1/12 (8.3%) 0/12 (0%) 1/12 (8.3%) 1/12 (8.3%)
    Eczema 0/12 (0%) 1/12 (8.3%) 0/12 (0%) 0/12 (0%)
    Hyperhidrosis 2/12 (16.7%) 2/12 (16.7%) 0/12 (0%) 1/12 (8.3%)
    Pruritus 5/12 (41.7%) 3/12 (25%) 4/12 (33.3%) 3/12 (25%)
    Skin atrophy 0/12 (0%) 0/12 (0%) 1/12 (8.3%) 0/12 (0%)
    Dermatitis contact 0/12 (0%) 0/12 (0%) 1/12 (8.3%) 0/12 (0%)
    Dermatitis exfoliative 0/12 (0%) 0/12 (0%) 1/12 (8.3%) 0/12 (0%)
    Psoriasis 1/12 (8.3%) 1/12 (8.3%) 0/12 (0%) 0/12 (0%)
    Skin lesion 1/12 (8.3%) 0/12 (0%) 0/12 (0%) 0/12 (0%)
    Erythema 1/12 (8.3%) 0/12 (0%) 2/12 (16.7%) 0/12 (0%)
    Rash 4/12 (33.3%) 4/12 (33.3%) 2/12 (16.7%) 3/12 (25%)
    Rash maculo-papular 0/12 (0%) 0/12 (0%) 0/12 (0%) 1/12 (8.3%)
    Skin irritation 0/12 (0%) 0/12 (0%) 1/12 (8.3%) 0/12 (0%)
    Night sweats 1/12 (8.3%) 0/12 (0%) 0/12 (0%) 0/12 (0%)
    Xeroderma 0/12 (0%) 0/12 (0%) 1/12 (8.3%) 0/12 (0%)
    Alopecia 4/12 (33.3%) 1/12 (8.3%) 3/12 (25%) 2/12 (16.7%)
    Rash generalised 0/12 (0%) 0/12 (0%) 1/12 (8.3%) 0/12 (0%)
    Skin fissures 1/12 (8.3%) 0/12 (0%) 0/12 (0%) 0/12 (0%)
    Vascular disorders
    Blood pressure fluctuation 0/12 (0%) 1/12 (8.3%) 0/12 (0%) 0/12 (0%)
    Flushing 0/12 (0%) 1/12 (8.3%) 1/12 (8.3%) 0/12 (0%)
    Arteriosclerosis 0/12 (0%) 0/12 (0%) 1/12 (8.3%) 0/12 (0%)
    Pallor 0/12 (0%) 0/12 (0%) 0/12 (0%) 1/12 (8.3%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    Bristol Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single center publications until after disclosure of the clinical trial's primary publication.

    Results Point of Contact

    Name/Title BristolMyers Squibb Study Director
    Organization Bristol-Myers Squibb International Corporation
    Phone
    Email clinical.trials@bms.com
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT00874770
    Other Study ID Numbers:
    • AI444-014
    • EUDRACT# 2009-010149-29
    First Posted:
    Apr 3, 2009
    Last Update Posted:
    Oct 23, 2015
    Last Verified:
    Sep 1, 2015