Safety and Efficacy Study of Daclatasvir 60mg, Sofosbuvir 400mg, and Ribavirin (Dosed Based Upon Weight) in Subjects With Chronic Genotype 3 Hepatitis C Infection With or Without Prior Treatment Experience and Compensated Advanced Cirrhosis for 12 or 16 Weeks

Hepatitis C Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02319031
• Other study ID #: AI444-326
• Status: Completed
• Phase: Phase 3
• First received: December 12, 2014
• Last updated: July 26, 2016
• Start date: February 2015
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationFrance: Ministry of HealthCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Inclusion Criteria:

• Must have Genotype 3 Chronic HCV

• Must have compensated advanced cirrhosis based upon laboratory tests

• HCV RNA Viral load = 10,000 IU/mL

Exclusion Criteria:

• Non Genotype 3 or mixed genotypes

• Non Cirrhotics

• Any prior treatment with NS5A inhibitors

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibrosis
• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• Daclatasvir

• Sofosbuvir

• Ribavirin

Locations

Country	Name	City	State
Australia	Local Institution	Adelaide	South Australia
Australia	Local Institution	Clayton	Victoria
Australia	Local Institution	Darlinghurst	New South Wales
Australia	Local Institution	Fitzroy	Victoria
Australia	Local Institution	Greenslopes	Queensland
Australia	Local Institution	Heidelberg	Victoria
France	Local Institution	Creteil Cedex
France	Local Institution	Grenoble Cedex 09
France	Local Institution	Paris Cedex 14
France	Local Institution	Vandoeuvre Les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

Australia,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with sustained virologic response a follow up Weeks 12 (SVR12), defined as HCV RNA < lower limit of quantification (LLOQ) target detected (TD) or target not detected (TND)		At post-treatment Week 12 (SVR12)	No
Secondary	On treatment safety, as measured by frequency of Serious Adverse Event (SAE)s, discontinuation due to Adverse Event (AE)s, Grade 3/4 AEs, and Grade 3/4 laboratory abnormalities		Up to End of Treatment (12 or 16 weeks) plus 7 days	Yes
Secondary	Proportion of subjects who achieve HCV RNA < LLOQ-TD/TND		At post-treatment Week 4 (SVR4) and Week 24 (SVR24)	Yes

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry form