DAAs Treatment for Chronic HCV/HBV Co-infection Patients(DASCO)

• Status: Completed
• Trial end date: 2021-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective study to determine the incidence, morbidity, mortality and predisposing factors for the reactivation of hepatitis B virus replication during direct anti-HCV treatment of HCV/HBV co-infection patients.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Humanity & Healthy GI and Liver Centre; Humanity and Health Research Centre
• Collaborators: Beijing 302 Hospital; Nanfang Hospital of Southern Medical University
• Treatments: Entecavir; Hepatitis C Antibodies; Ledipasvir; Ledipasvir, sofosbuvir drug combination; Ritonavir; Sofosbuvir; Tenofovir

Criteria

Inclusion Criteria:

• HCV RNA positive,

• HBsAg positive with detectable or undetectable HBV DNA,

• Receiving pan oral direct-acting anti-HCV regimen

Exclusion Criteria:

• Pregnant or nursing female or male with pregnant female partner;

• HIV infection;

• Hematologic or biochemical parameters at Screening outside the protocol- specified requirements;

• Active or recent history (≤ 1 year) of drug or alcohol abuse;

• History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.