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

NCT02555943 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2021-09-01

No results posted yet for this study

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.

Conditions

  • Chronic Hepatitis C Infection
  • HBV Coinfection
  • Hepatitis B Reactivation

Interventions

DRUG

Ledipasvir/Sofosbuvir

Oral direct anti-HCV agent. Ledipasvir/Sofosbuvir(LDV/SOF) 400mg/90mg fixed-dose combination(FDC) tablet, administered orally once daily.

DRUG

Sofosbuvir and Daclatasvir

TWO oral direct anti-HCV agent: Sofosbuvir(SOF), 400mg tablet administered orally once daily. Daclatavir(DCV), 60mg tablet administered orally once daily.

DRUG

Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir

VIEKIRA PAK includes ombitasvir, a hepatitis C virus NS5A inhibitor, paritaprevir, a hepatitis C virus NS3/4A protease inhibitor, ritonavir, a CYP3A inhibitor and dasabuvir, a hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor.

DRUG

Entecavir

Nucleoside-inhibitor-treatment-naïve with compensated liver disease (greater than or equal to 16 years old): 0.5 mg once daily.

DRUG

Tenofovir disoproxil

VIREAD is indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older.

Sponsors & Collaborators

  • Beijing 302 Hospital

    collaborator OTHER

  • Nanfang Hospital, Southern Medical University

    collaborator OTHER

  • Humanity and Health Research Centre

    lead OTHER

Principal Investigators

  • George Lau, M.D. · Humanity and Health GI and Liver Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2021-05-31
Completion
2021-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02555943 on ClinicalTrials.gov