NCT02673489 - A Study of Daclatasvir and Sofosbuvir With Ribavirin in Subjects With Cirrhosis and Genotype 3 Hepatitis C Infection | Crick

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Enrollment

106

Conditions

Hepatitis C

Interventions

DCVDRUG

SOFDRUG

RBVDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (19)

Keck Medical Center Of USC

Los Angeles, California, United States

University Of California, San Francisco

San Francisco, California, United States

Outcomes

Primary Outcomes

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.

Time frame: Week 12

Secondary Outcomes

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.

Time frame: Week 12 (Follow-up period)

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.

Time frame: 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)

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.