A Study of Daclatasvir and Sofosbuvir With Ribavirin in Subjects With Cirrhosis and Genotype 3 Hepatitis C Infection

Hepatitis C Clinical Trial

Official title:

A Phase 3 Evaluation of Daclatasvir and Sofosbuvir With Ribavirin in Cirrhotic Subjects With Genotype 3 Chronic Hepatitis C Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02673489
• Other study ID #: AI444-379
• Secondary ID: 2015-004331-12
• Status: Completed
• Phase: Phase 3
• Start date: March 15, 2016
• Est. completion date: May 26, 2017

Study information

• Verified date: April 2018
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: May 26, 2017
• Est. primary completion date: March 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• DCV

• SOF

• RBV

Locations

Country	Name	City	State
Canada	Local Institution	Calgary	Alberta
Canada	Local Institution	Edmonton	Alberta
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Regina	Saskatchewan
Canada	Local Institution	Toronto	Ontario
Canada	Local Institution	Vancouver	British Columbia
Canada	Local Institution	Victoria	British Columbia
United States	Texas Clinical Research Institute	Arlington	Texas
United States	Northeast Clinical Research Center	Bethlehem	Pennsylvania
United States	Digestive Disease Associates, PA	Catonsville	Maryland
United States	Ruth Rothstein Core Center	Chicago	Illinois
United States	Methodist Transplant Physicians	Dallas	Texas
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	Keck Medical Center Of USC	Los Angeles	California
United States	Gastrointestinal Specialists of Georgia, PC	Marietta	Georgia
United States	University Gastroenterology	Providence	Rhode Island
United States	Bon Secours St. Mary's Hospital of Richmond, Inc	Richmond	Virginia
United States	The Texas Liver Institute	San Antonio	Texas
United States	University Of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Sustained Virologic Response (SVR12)	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.	Week 12
Secondary	Percentage of Participants Who Achieve SVR12 in the Presence and Absence of Baseline NS5A (Non-structural Protein 5A) Resistance-associated Polymorphisms	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.	Week 12 (Follow-up period)
Secondary	Percentage of Subjects Who Achieve HCV RNA < LLOQ, TD or TND Through 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. SVR12 is based on Next Value Carried Backwards approach.	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)
Secondary	Percentage of Subjects Who Achieve HCV RNA < LLOQ, TND Through 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.	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

External Links

•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form