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A Randomized, Open-Label Study of Daclatasvir and Sofosbuvir With or Without Ribavirin for 8 Weeks in Treatment-Naïve, Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus (HCV) Genotype 3

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ClinicalTrials.gov Identifier: NCT02551861
Recruitment Status : Withdrawn
First Posted : September 16, 2015
Last Update Posted : January 15, 2016
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to determine if 8 weeks of Daclatasvir plus Sofosbuvir with or without Ribavirin is safe and effective in the treatment of genotype 3 hepatitis C infected patients without advanced fibrosis or liver cirrhosis who have never been treated previously.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: Daclatasvir Drug: Sofosbuvir Drug: Ribavirin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label Study of Daclatasvir and Sofosbuvir With or Without Ribavirin for 8 Weeks in Treatment-Naïve, Non-Cirrhotic Subjects Infected With Chronic HCV Genotype 3
Study Start Date : December 2015
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Daclatasvir + Sofosbuvir
Daclatasvir 60mg tablet and Sofosbuvir 400mg tablet oral dosing once daily for 8 weeks
Drug: Daclatasvir
Drug: Sofosbuvir
Active Comparator: Daclatasvir + Sofosbuvir + Ribavirin
Daclatasvir 60mg tablet + Sofosbuvir 400mg tablet+ Ribavirin 1000-1200mg tablet(weight based dosing) oral dosing split into am and pm once daily for 8 weeks
Drug: Daclatasvir
Drug: Sofosbuvir
Drug: Ribavirin



Primary Outcome Measures :
  1. Proportion of subjects with sustained virologic response (SVR12) treated with Daclatasvir + Sofosbuvir (DCV+SOF) [ Time Frame: Post Treatment Follow up Week 12 ]
    SVR12 defined as HCV RNA < LLOQ target detected (TD) or target not detected (TND) at follow-up Week 12 in subjects treated with 8 weeks of DCV+SOF therapy or DCV+SOF+RBV therapy


Secondary Outcome Measures :
  1. Safety measured by number of incidence of deaths, serious adverse events (SAE)s, discontinuation due to adverse events (AE)s, Grade 3/4 AEs and Grade 3/4 laboratory abnormalities observed from clinical laboratory testing [ Time Frame: Approximately 1.5 years ]
  2. Antiviral activity measured by the proportion of subjects who achieve HCV RNA < lower limit of quantification (LLOQ) - at during and after treatment in each treatment arm [ Time Frame: Post treatment follow up Week 24 ]
  3. Proportion of subjects with CC, CT or TT IL28B genotype who achieve SVR12 in each treatment arm [ Time Frame: Post Treatment Follow up Week 12 ]


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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:

  • Genotype 3
  • HCV RNA < 2000000 IU/mL
  • Never taken HCV medication
  • Absence of advanced fibrosis or cirrhosis
  • Body mass index (BMI) 18-40 kg/m^2

Exclusion Criteria:

  • Infection with HCV other than genotype 3 (GT3); Mixed infections of any genotype
  • Previously taken HCV medication
  • Liver Cirrhosis
  • Evidence of decompensated liver disease
  • HIV/ hepatitis B virus (HBV) coinfection

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): NCT02551861


Locations
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Canada, Alberta
Local Institution
Calgary, Alberta, Canada, T2N 4Z6
Local Institution
Edmonton, Alberta, Canada, T6G 2S2
Canada, British Columbia
Local Institution
Vancouver, British Columbia, Canada, V5Z 1H2
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
France
Local Institution
Creteil Cedex, France, 94010
Local Institution
Limoges, France, 87042
Local Institution
Montpellier Cedex 5, France, 34295
Local Institution
Paris Cedex 14, France, 75679
Local Institution
Pessac, France, 33604
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:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02551861     History of Changes
Other Study ID Numbers: AI444-377
2015-003468-36 ( EudraCT Number )
First Posted: September 16, 2015    Key Record Dates
Last Update Posted: January 15, 2016
Last Verified: January 2016

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