CompletedPhase 2/3

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

China23 participantsStarted 2015-02

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Proportion of participants who experience virological breakthrough

Timeframe: From the commencement of DAAs treatment to 12 weeks post DAAs treatment

Proportion of participants who experience virological rebound

Timeframe: From the commencement of DAAs treatment to 12 weeks post DAAs treatment

Trial details

NCT IDNCT02555943

SponsorHumanity and Health Research Centre

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-05

View on ClinicalTrials.gov More Chronic Hepatitis C Infection trials