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Safety and Efficacy Study of the Combination Daclatasvir (60 mg), Sofosbuvir (400 mg) and Ribavirin (Weight-based Dosing) for 12 or 16 Weeks in Subjects With Genotype 3 Chronic HCV Infection With or Without Prior Treatment Experience and Advanced Fibrosis or Compensated Cirrhosis

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: NCT02319031
Recruitment Status : Completed
First Posted : December 18, 2014
Results First Posted : January 27, 2017
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of the study is to determine if the combination of Daclatasvir, Sofosbuvir and Ribavirin for 12 or 16 weeks is safe and effective in the treatment of Genotype 3 Chronic Hepatitis C (HCV) in patients with advanced fibrosis or compensated cirrhosis. Patients in this study may have already been treated prior for HCV or may have never received treatment for their HCV.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label, Randomized Study of Daclatasvir, Sofosbuvir, and Ribavirin for 12 vs. 16 Weeks in Treatment Naive and Treatment Experienced Patients With Genotype 3 Chronic Hepatitis C Infection Subjects With Compensated Advanced Fibrosis/Cirrhosis (F3/F4)
Study Start Date : February 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : December 2015


Arm Intervention/treatment
Active Comparator: Arm1: Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)
Oral dosing Daclatasvir 60mg once daily, Sofosbuvir 400mg once daily, and Ribavirin 1000-1200mg (weight based dosing) split into am and pm dosing
Drug: Daclatasvir
Drug: Sofosbuvir
Drug: Ribavirin
Active Comparator: Arm2 : Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)
Oral dosing Daclatasvir 60mg once daily, Sofosbuvir 400mg once daily, and Ribavirin 1000-1200mg (weight based dosing) split into am and pm dosing
Drug: Daclatasvir
Drug: Sofosbuvir
Drug: Ribavirin



Primary Outcome Measures :
  1. Percent of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 (SVR12) [ Time Frame: Follow-up Week 12 ]
    SVR12, defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) at follow-up Week 12. SVR12 imputation was based on Next Value Carried Backwards (NVCB) approach. HCV RNA measurements were excluded after the start of non-study anti-HCV medication on treatment or during follow-up.


Secondary Outcome Measures :
  1. Percent of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 4 (SVR4) and Follow-up Week 24 (SVR24) [ Time Frame: Follow-up Weeks 4 and 24 ]
    SVR4, defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) at follow-up Week 4. SVR24, defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) at follow-up Week 24. SVR4 imputation was based on Next Value Carried Backwards (NVCB) approach. SVR24 imputation was based on missing being treated as non-responder. HCV RNA measurements were excluded after the start of non-study anti-HCV medication on treatment or during follow-up.

  2. Number of Participants With Death, Serious Adverse Events (SAEs), Discontinuation Due to Adverse Events (AEs), Grade 3 or Grade 4 (Grade 3/4) AEs, and Grade 3/4 Laboratory Abnormalities [ Time Frame: Date of First Dose of Study Drug to 7 Days post last dose of study drug (up to 13 weeks or 17 weeks depending on the randomized treatment group) ]
    Serious adverse event (SAE) defined: a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. The degree of the adverse event or laboratory abnormality are evaluated by grades: Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. Grading as per using National Cancer Institute Common Terminology Criteria (NCI CTC) Version 3.0 criteria.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Inclusion Criteria:

  • Must have Genotype 3 Chronic HCV
  • Must have advanced fibrosis (F3) or compensated cirrhosis (F4)
  • HCV RNA Viral load ≥ 10,000 IU/mL
  • HCV Treatment naive or treatment-experienced

Exclusion Criteria:

  • Non Genotype 3 or mixed genotypes
  • Non advanced fibrosis or compensated cirrhosis
  • Any prior treatment with NS5A inhibitors

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): NCT02319031


Locations
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Australia, New South Wales
Local Institution
Darlinghurst, New South Wales, Australia, 2010
Australia, Queensland
Local Institution
Greenslopes, Queensland, Australia, 4120
Australia, South Australia
Local Institution
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Local Institution
Clayton, Victoria, Australia, 3168
Local Institution
Fitzroy, Victoria, Australia, 3065
Local Institution
Heidelberg, Victoria, Australia, 3084
France
Local Institution
Creteil Cedex, France, 94010
Local Institution
Grenoble Cedex 09, France, 38043
Local Institution
Paris Cedex 14, France, 75679
Local Institution
Vandoeuvre Les Nancy, France, 54511
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol - Myers Squibb Bristol-Myers Squibb

Additional Information:
Study Data/Documents: Primary Publication  This link exits the ClinicalTrials.gov site
Identifier: PMID: 26822022

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02319031    
Other Study ID Numbers: AI444-326
First Posted: December 18, 2014    Key Record Dates
Results First Posted: January 27, 2017
Last Update Posted: January 27, 2017
Last Verified: December 2016
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
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents