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Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCV (ALLY 3)

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ClinicalTrials.gov Identifier: NCT02032901
Recruitment Status : Completed
First Posted : January 10, 2014
Results First Posted : September 14, 2015
Last Update Posted : October 1, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
To study the combination of Daclatasvir and Sofosbuvir for the treatment of hepatitis C virus (HCV) Genotype 3 infection

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: Daclatasvir Drug: Sofosbuvir Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 173 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Evaluation of Daclatasvir and Sofosbuvir in Treatment Naive and Treatment Experienced Subjects With Genotype 3 Chronic Hepatitis C Infection
Study Start Date : January 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A1:Daclatasvir + Sofosbuvir in treatment-naive subjects
Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks
Drug: Daclatasvir
Other Name: BMS-790052

Drug: Sofosbuvir
Experimental: A2:Daclatasvir + Sofosbuvir in treatment-experienced subjects
Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks
Drug: Daclatasvir
Other Name: BMS-790052

Drug: Sofosbuvir



Primary Outcome Measures :
  1. Percentage of Treatment-Naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND) [ Time Frame: Week 12 (Follow-up period) ]
    SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie., 25 IU/mL, TD or TND at follow-up Week 12. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory.

  2. Percentage of Treatment-Experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND) [ Time Frame: Week 12 (Follow-up period) ]
    SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie., 25 IU/mL, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.


Secondary Outcome Measures :
  1. Percentage of Participants With Rapid Virologic Response at Week 4 (RVR) Target Not Detected (TND) [ Time Frame: Week 4 ]
    RVR was defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at Week 4. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.

  2. Percentage of Participants With Complete Early Virologic Response (cEVR) Target Not Detected (TND) [ Time Frame: Week 12 ]
    cEVR was defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.

  3. Percentage of Participants With End of Treatment Response (EOTR) Target Not Detected (TND) [ Time Frame: Up to the end of treatment (up to 24 weeks) ]
    EOTR were defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at end of treatment. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.

  4. Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ) - Target Not Detected (TND) [ Time Frame: Week 1, 2, 6, 8 (treatment period) ]
    Percentage of participants who achieved HCV RNA <LLOQ, TND was determined (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.

  5. Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ)- Target Detected (TD) or Target Not Detected (TND) [ Time Frame: Week 1, 2, 4, 6, 8, 12, End of treatment (treatment period), Week 4 (follow-up period), Week 24 (follow-up period) ]
    Percentage of participants who achieved HCV RNA <LLOQ,TD or TND was determined (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.

  6. Percentage of Participants With Or Without Cirrhosis at Baseline Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12) [ Time Frame: Baseline, Week 12 (Follow-up period) ]
    SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie. 25 IU/mL, target detected or target not detected at follow-up Week 12. Cirrhosis was considered a negative predictor of SVR in participants treated with an interferon formulation or ribavirin. Presence or absence of cirrhosis was determined at baseline and follow-up Week 12 in the participants to evaluate the post-treatment relapse.

  7. Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms (SNPs) Who Achieved Sustained Virologic Response After 12 Weeks of Follow-up (SVR12) [ Time Frame: Week 12 (Follow-up period) ]
    Participants categorized into 2 genotypes (CC and non-CC) based on SNPs in the IL28B gene were assessed for SVR12, defined as response in which hepatitis C virus (HCV) RNA levels below lower limit of quantitation (LLOQ) below target detected or target not detected at follow-up Week 12 (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.

  8. Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) [ Time Frame: From Day 1 first dose to last dose plus 7 days ]
    AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Key Inclusion Criteria:

  • Subjects must be able to understand and agree to comply with the prescribed dosing regimens and procedures, report for regularly scheduled study visits, and reliably communicate with study personnel about adverse events and concomitant medications
  • Subjects chronically infected with hepatitis C virus (HCV) genotype 3
  • Subjects who are HCV treatment-naive
  • Subjects who are HCV treatment-experienced (previous exposure to non-structural 5A inhibitors is prohibited)
  • HCV RNA ≥10,000 IU/mL at screening

Key Exclusion Criteria:

  • HCV Genotypes other than genotype-3 infection; mixed genotype infections are not permitted
  • Liver or any other organ transplant (including hematopoietic stem cell transplants) other than cornea and hair
  • Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to screening
  • Documented or suspected hepatocellular carcinoma, as evidenced by previously obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this was performed)
  • Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032901


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Locations
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United States, California
Scripps Clinic
La Jolla, California, United States, 92037
Peter J Ruane MD Inc
Los Angeles, California, United States, 90036
National Research Institute
Los Angeles, California, United States, 90057
Anthony M. Mills MD Inc
Los Angeles, California, United States, 90069
Huntington Medical Research Institutes
Pasadena, California, United States, 91105
Precision Research Institute, LLC
San Diego, California, United States, 92114
Medical Associates Research Group
San Diego, California, United States, 92123
Quest Clinical Research
San Francisco, California, United States, 94115
United States, Florida
Midland Florida Clinical Research Center, LLC
Deland, Florida, United States, 32720
University of Florida Hepatology Research
Gainesville, Florida, United States, 32610
United States, Georgia
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States, 30308
Gastrointestinal Specialists Of Georgia
Marietta, Georgia, United States, 30060
United States, Illinois
Dupage Medical Group
Downers Grove, Illinois, United States, 60515
United States, Maryland
Mercy Medical Center, Inc.
Baltimore, Maryland, United States, 21202
Digestive Disease Associates, P.A.
Baltimore, Maryland, United States, 21229
United States, Missouri
Kansas City Research Institute
Kansas City, Missouri, United States, 64131
United States, New Mexico
Southwest Care Center
Santa Fe, New Mexico, United States, 87505
United States, New York
North Shore University Hospital
Manhasset, New York, United States, 11030
Premier Medical Group Of The Hudson Valley, Pc
Poughkeepsie, New York, United States, 12601
United States, North Carolina
Asheville Gastroenterology Associates, PA
Asheville, North Carolina, United States, 28801
Digestive Health Specialists, PA
Winston-salem, North Carolina, United States, 27103
United States, Pennsylvania
Main Line Gastroenterology Associates Pc
Perkasie, Pennsylvania, United States, 18944
Center For Liver Diseases
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Gastro One
Germantown, Tennessee, United States, 38138
United States, Texas
Texas Clinical Research Institute, LLC
Arlington, Texas, United States, 76012
American Research Corporation
San Antonio, Texas, United States, 78215
United States, Utah
Clinical Research Centers Of America
Murray, Utah, United States, 84123
Lifetree Clinical Research
Salt Lake City, Utah, United States, 84106
United States, Virginia
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Puerto Rico
Fundacion De Investigacion De Diego
San Juan, Puerto Rico, 00927
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02032901     History of Changes
Other Study ID Numbers: AI444-218
First Posted: January 10, 2014    Key Record Dates
Results First Posted: September 14, 2015
Last Update Posted: October 1, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Sofosbuvir
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Flaviviridae Infections
Antiviral Agents
Anti-Infective Agents