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Phase III Hallmark QUAD: ASV+DCV+Peg+Rib (Nulls/Partials)

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT01573351
Collaborator
(none)
398
Enrollment
79
Locations
1
Arm
19
Duration (Months)
5
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess efficacy, as determined by the proportion of subjects with Sustained Virologic Response at Post-Treatment Week 12 (SVR12), defined as Hepatitis C virus (HCV) Ribonucleic acid (RNA) < Limit of quantitation (LOQ) at post-treatment Week 12.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

  • ASV = Asunaprevir (BMS-650032)

  • DCV = Daclatasvir (BMS-790052)

  • Peg = Peg-interferon Alfa-2a (PegIFN)

  • Rib = Ribavirin (RBV)

Study Design

Study Type:
Interventional
Actual Enrollment :
398 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Open-Label Study With Asunaprevir and Daclatasvir Plus Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) (P/R) (QUAD) for Subjects Who Are Null or Partial Responders to Peginterferon Alfa 2a or 2b Plus Ribavirin With Chronic Hepatitis C Genotypes 1 or 4 Infection
Study Start Date :
May 1, 2012
Actual Primary Completion Date :
Sep 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: QUAD: Asunaprevir+Daclatasvir+Peg-interferon Alfa-2a+Ribavirin

Asunaprevir: Capsule, Oral, 100 mg, Twice daily, 24 weeks Daclatasvir: Tablet, Oral, 60 mg, Once daily, 24 weeks Peg-interferon Alfa-2a: Injection, subcutaneous (SC), 180 mcg/0.5 mL, Once weekly, 24 weeks Ribavirin: Tablet, Oral, 1000 mg/1200 mg (total daily dose), 24 weeks

Drug: Asunaprevir
Other Names:
  • BMS-650032

    • Drug: Daclatasvir
    Other Names:
  • BMS-790052

    • Drug: Peg-interferon Alfa-2a
    Other Names:
  • Pegasys®

    • Drug: Ribavirin
    Other Names:
  • Copegus®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of genotype 1 subjects with SVR12, defined as HCV RNA < LOQ at post-treatment Week 12, for all subjects infected with HCV genotype 1 [At 12 weeks post-treatment]

    Secondary Outcome Measures

    1. On-treatment safety, as measured by frequency of Serious Adverse Events (SAEs) and discontinuations due to Adverse Events (AEs) through the end of treatment [Through the end of treatment (maximum up to 24 weeks) plus 7 days]

    2. Proportion of subjects with SVR12 (HCV RNA < LOQ at post-treatment Week 12) by the rs12979860 single nucleotide polymorphisms (SNP) in the IL28 gene [At post-treatment Week 12]

    3. Proportion of subjects with HCV RNA undetectable [Weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [Extended rapid virologic response (eRVR)], end of treatment (up to 24 weeks), post-treatment Week 12 or post-treatment Week 24]

    4. Proportion of subjects with HCV RNA < LOQ [Weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12, end of treatment (up to 24 weeks), post-treatment Week 24 (SVR24)]

    5. Proportion of patients with SVR12 (HCV RNA < LOQ at post-treatment Week 12) for HCV genotype 4 subjects [Post-treatment Week 12]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Males and females, ≥ 18 years of age

    • HCV Genotype 1 or 4 who previously failed treatment with Peginterferon alfa-2a or peginterferon alfa-2b and Ribavirin (P/R), classified as previous null and partial responders based on previous therapy

    • HCV RNA ≥ 10,000 IU/mL

    • Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen (HBsAg)

    • Subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 25% of treated population)

    Exclusion Criteria:

    • Prior treatment of HCV with HCV direct acting antiviral (DAA)

    • Evidence of a medical condition contributing to chronic liver disease other than HCV

    • Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy

    • Diagnosed or suspected hepatocellular carcinoma or other malignancies

    • Uncontrolled diabetes or hypertension

    • Total bilirubin ≥ 34 μmol/L (or ≥ 2 mg/dL) unless subject has a documented history of Gilbert's disease

    • Alanine aminotransferase (ALT) ≥ 5x Upper limit of normal (ULN)

    • Albumin < 3.5 g/dL (35 g/L)

    • Alpha Fetoprotein (AFP) > 100 ng/mL (>82.6 IU/mL) or ≥ 50 and ≤ 100 ng/mL requires a liver ultrasound and subjects with findings suspicious of Hepatocellular carcinoma (HCC) are excluded

    • Absolute neutrophil count (ANC) < 1.5 x 1000,000,000 cells/L (< 1.2 x 1000,000,000 cells/L for Black/African-Americans)

    • Platelets < 90 x 1000,000,000 cells/L

    • Hemoglobin < 12 g/dL for females or < 13 g/dL for males

    • Any criteria that would exclude the subject from receiving P/R

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alabama Liver & Digestive Specialists (Alds) Montgomery Alabama United States 36116
    2 Scripps Clinic La Jolla California United States 92037
    3 Scpmg/ Kaiser Permanente Los Angeles Medical Center Los Angeles California United States 90027
    4 University Of Colorado Denver And Hospital Aurora Colorado United States 80045
    5 South Denver Gastroenterology, Pc Englewood Colorado United States 80113
    6 Mayo Clinic Jacksonville Florida United States 32224
    7 University Of Miami Schiff Center For Liver Diseases Miami Florida United States 33136
    8 University Of Chicago Medical Center Chicago Illinois United States 60637-1432
    9 North Shore University Hospital Manhasset New York United States 11030
    10 University Of North Carolina At Chapel Hill School Of Med Chapel Hill North Carolina United States 27599-7584
    11 University Of Cincinnati Cincinnati Ohio United States 45267
    12 Options Health Research, Llc Tulsa Oklahoma United States 74104
    13 Oregon Health & Science University Portland Oregon United States 97239
    14 University Of Pennsylvania Philadelphia Pennsylvania United States 19104
    15 Thomas Jefferson University Philadelphia Pennsylvania United States 19107
    16 Gastro One Germantown Tennessee United States 38138
    17 Baylor College Of Medicine Houston Texas United States 77030
    18 Texas Liver Institute San Antonio Texas United States 78215
    19 Mcguire Dvamc Richmond Virginia United States 23249
    20 Dean Clinic Madison Wisconsin United States 53715
    21 Local Institution Ciudad De Buenos Aires Buenos Aires Argentina C1121ABE
    22 Local Institution Mar Del Plata Buenos Aires Argentina 7600
    23 Local Institution Prov. Buenos Aires Buenos Aires Argentina 1629
    24 Local Institution Edmonton Alberta Canada T6G 2B7
    25 Local Institution Vancouver British Columbia Canada V6Z 2K5
    26 Local Institution Victoria British Columbia Canada V8V 3P9
    27 Local Institution Toronto Ontario Canada M6H 3M1
    28 Local Institution Montreal Quebec Canada H2L 4P9
    29 Local Institution Aalborg Denmark 9100
    30 Local Institution Hvidovre Denmark 2650
    31 Local Institution Odense Denmark 5000
    32 Local Institution Creteil France 94000
    33 Local Institution Montpellier Cedex 5 France 34295
    34 Local Institution Nice Cedex 03 France 06202
    35 Local Institution Paris Cedex 12 France 75571
    36 Local Institution Paris Cedex 14 France 75679
    37 Local Institution Pessac France 33604
    38 Local Institution Berlin Germany 13353
    39 Local Institution Duesseldorf Germany 40237
    40 Local Institution Frankfurt Germany 60590
    41 Local Institution Freiburg Germany 79106
    42 Local Institution Hamburg Germany 20246
    43 Local Institution Heidelberg Germany 69120
    44 Local Institution Tuebingen Germany 72076
    45 Local Institution Brescia Italy 25123
    46 Local Institution Cisanello (pisa) Italy 56124
    47 Local Institution Milano Italy 20122
    48 Local Institution Palermo Italy 90127
    49 Local Institution Bucheon-si Korea, Republic of 420-767
    50 Local Institution Busan Korea, Republic of 602-715
    51 Local Institution Busan Korea, Republic of 602-739
    52 Local Institution Busan Korea, Republic of 614-735
    53 Local Institution Daegu Korea, Republic of 700-721
    54 Local Institution Gyeongsangnam-do Korea, Republic of 626-770
    55 Local Institution Incheon Korea, Republic of 400-711
    56 Local Institution Incheon Korea, Republic of 403-720
    57 Local Institution Seoul Korea, Republic of 120-752
    58 Local Institution Seoul Korea, Republic of 135-710
    59 Local Institution Mexico Distrito Federal Mexico 03720
    60 Local Institution Mexico City Estado De Mexico Mexico 06700
    61 Local Institution Amsterdam Netherlands 1105 AZ
    62 Local Institution Rotterdam Netherlands 3015 CE
    63 Local Institution Moscow Russian Federation 117593
    64 Local Institution Moscow Russian Federation 127015
    65 Local Institution Saint-Petersburg Russian Federation 194044
    66 Local Institution Stavropol Russian Federation 355000
    67 Local Institution Tyumen Russian Federation 625026
    68 Local Institution Alcorcon Spain 28922
    69 Local Institution Barcelona Spain 08916
    70 Local Institution Madrid Spain 28029
    71 Local Institution Sevilla Spain 41014
    72 Local Institution Gvteborg Sweden SE-41685
    73 Local Institution Stockholm Sweden 141 86
    74 Local Institution Bern Switzerland 3010
    75 Local Institution Lausanne Switzerland 1011
    76 Local Institution Chia-Yi Taiwan 600
    77 Local Institution Kaohsiung Taiwan 807
    78 Local Institution Taichung Taiwan 40705
    79 Local Institution Taipei Taiwan 11217

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT01573351
    Other Study ID Numbers:
    • AI447-029
    • 2011-005422-21
    First Posted:
    Apr 9, 2012
    Last Update Posted:
    Oct 9, 2015
    Last Verified:
    Sep 1, 2015
    Additional relevant MeSH terms:
    Hepatitis C
    Hepatitis
    Interferons
    Ribavirin
    Interferon-alpha
    Interferon alpha-2
    Peginterferon alfa-2a
    Asunaprevir

    Study Results

    No Results Posted as of Oct 9, 2015