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

Phase 3

Completed

• Conditions: Hepatitis C
• Interventions: Drug: DCV; Drug: SOF; Drug: RBV

• Registration Number: NCT02673489
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-28
• Study First Submitted QC: 2016-02-01
• Study First Posted: 2016-02-04
• Study Start: 2016-03-15
• Primary Completion: 2017-03-02
• Study Completion: 2017-05-26
• Results First Submitted: 2018-03-01
• Results First Submitted QC: 2018-03-01
• Results First Posted: 2018-03-29
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-09
• Last Update Posted: 2018-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Daclatasvir (DCV) + Sofosbuvir (SOF) + Ribavirin (RBV)	SOF	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.
Daclatasvir (DCV) + Sofosbuvir (SOF) + Ribavirin (RBV)	DCV	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.
Daclatasvir (DCV) + Sofosbuvir (SOF) + Ribavirin (RBV)	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Sustained Virologic Response (SVR12)	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

Name	Time	Method
Percentage of Subjects Who Achieve HCV RNA < LLOQ, TND Through Follow up Week 24	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.
Percentage of Subjects Who Achieve HCV RNA < LLOQ, TD or TND Through Follow up Week 24	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.
Percentage of Participants Who Achieve SVR12 in the Presence and Absence of Baseline NS5A (Non-structural Protein 5A) Resistance-associated Polymorphisms	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.

Trial Locations

Locations (13)

Northeast Clinical Research Center; 🇺🇸 Bethlehem, Pennsylvania, United States

Bon Secours St. Mary's Hospital of Richmond, Inc; 🇺🇸 Richmond, Virginia, United States

University Gastroenterology; 🇺🇸 Providence, Rhode Island, United States

Local Institution; 🇨🇦 Regina, Saskatchewan, Canada

Ruth Rothstein Core Center; 🇺🇸 Chicago, Illinois, United States

University Of California, San Francisco; 🇺🇸 San Francisco, California, United States

Keck Medical Center Of USC; 🇺🇸 Los Angeles, California, United States

Digestive Disease Associates, PA; 🇺🇸 Catonsville, Maryland, United States

Texas Clinical Research Institute; 🇺🇸 Arlington, Texas, United States

Methodist Transplant Physicians; 🇺🇸 Dallas, Texas, United States

The Texas Liver Institute; 🇺🇸 San Antonio, Texas, United States

Inova Fairfax Hospital; 🇺🇸 Falls Church, Virginia, United States

Gastrointestinal Specialists of Georgia, PC; 🇺🇸 Marietta, Georgia, United States