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Trial record 1 of 1 for:    A Study of Daclatasvir and Sofosbuvir With Ribavirin in Subjects With Cirrhosis and Genotype 3 Hepatitis C Infection
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A Study of Daclatasvir and Sofosbuvir With Ribavirin in Subjects With Cirrhosis and Genotype 3 Hepatitis C Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02673489
Recruitment Status : Completed
First Posted : February 4, 2016
Results First Posted : March 29, 2018
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to determine whether 24 weeks of Daclatasvir and Sofosbuvir with Ribavirin is safe and effective in the treatment of genotype 3 hepatitis C infected patients with liver cirrhosis.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: DCV Drug: SOF Drug: RBV Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Evaluation of Daclatasvir and Sofosbuvir With Ribavirin in Cirrhotic Subjects With Genotype 3 Chronic Hepatitis C Infection
Actual Study Start Date : March 15, 2016
Actual Primary Completion Date : March 2, 2017
Actual Study Completion Date : May 26, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Daclatasvir (DCV) + Sofosbuvir (SOF) + Ribavirin (RBV)
Oral dosing of DCV 60 mg tablet once daily + SOF 400 mg tablet once daily + RBV 1000-1200 mg tablet per day (weight based) for 24 weeks.
Drug: DCV
Drug: SOF
Drug: RBV



Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response (SVR12) [ Time Frame: Week 12 ]
    SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up. Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria and the Next Value Carried Backwards approach.


Secondary Outcome Measures :
  1. Percentage of Participants Who Achieve SVR12 in the Presence and Absence of Baseline NS5A (Non-structural Protein 5A) Resistance-associated Polymorphisms [ Time Frame: Week 12 (Follow-up period) ]
    SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up. Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria and the Next Value Carried Backwards approach.

  2. Percentage of Subjects Who Achieve HCV RNA < LLOQ, TD or TND Through Follow up Week 24 [ Time Frame: At Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, End of Treatment (24 weeks), Follow Up Week 4 (28 weeks), Follow Up Week 12 (36 weeks), Follow Up Week 24 (48 weeks) ]
    HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up. Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria. SVR12 is based on Next Value Carried Backwards approach.

  3. Percentage of Subjects Who Achieve HCV RNA < LLOQ, TND Through Follow up Week 24 [ Time Frame: At Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, End of Treatment, Follow Up Week 4, Follow Up Week 12, Follow Up Week 24 ]

    HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up.

    Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria.




Information from the National Library of Medicine

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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 Bristol-Myers Squibb (BMS) Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Genotype 3 HCV
  • HCV RNA ≥10000 IU (International Unit)/mL
  • Compensated Liver Cirrhosis
  • BMI 18-40 kg/m2
  • Previously treated for HCV or never treated for HCV

Exclusion Criteria:

  • Infection with HCV other than Genotype 3. Mixed infection of any genotype
  • Evidence of decompensated liver disease
  • Previous exposure to NS5A inhibitors

Other protocol defined inclusion/exclusion criteria could apply


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): NCT02673489


Locations
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United States, California
Keck Medical Center Of USC
Los Angeles, California, United States, 90033
University Of California, San Francisco
San Francisco, California, United States, 94143
United States, Georgia
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, United States, 30060
United States, Illinois
Ruth Rothstein Core Center
Chicago, Illinois, United States, 60612
United States, Maryland
Digestive Disease Associates, PA
Catonsville, Maryland, United States, 21228
United States, Pennsylvania
Northeast Clinical Research Center
Bethlehem, Pennsylvania, United States, 18017
United States, Rhode Island
University Gastroenterology
Providence, Rhode Island, United States, 02905
United States, Texas
Texas Clinical Research Institute
Arlington, Texas, United States, 76012
Methodist Transplant Physicians
Dallas, Texas, United States, 75203
The Texas Liver Institute
San Antonio, Texas, United States, 78215
United States, Virginia
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Bon Secours St. Mary's Hospital of Richmond, Inc
Richmond, Virginia, United States, 23226
Canada, Alberta
Local Institution
Calgary, Alberta, Canada, T2N 4Z6
Local Institution
Edmonton, Alberta, Canada, T6G 2P4
Canada, British Columbia
Local Institution
Vancouver, British Columbia, Canada, V6Z 2K5
Local Institution
Victoria, British Columbia, Canada, V8V 3P9
Canada, Ontario
Local Institution
Toronto, Ontario, Canada, M5G 2C4
Canada, Quebec
Local Institution
Montreal, Quebec, Canada, H3T 1E2
Canada, Saskatchewan
Local Institution
Regina, Saskatchewan, Canada, S4O 0W5
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:
Statistical Analysis Plan  [PDF] December 14, 2015
Study Protocol  [PDF] December 14, 2015


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: NCT02673489     History of Changes
Other Study ID Numbers: AI444-379
2015-004331-12 ( EudraCT Number )
First Posted: February 4, 2016    Key Record Dates
Results First Posted: March 29, 2018
Last Update Posted: May 8, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Sofosbuvir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents