NCT02555943

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

Direct Antiviral Agents for the Treatment of Chronic HCV/HBV Co-infection Patients

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Humanity and Health Research Centre · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients who receive direct-acting anti-HCV treatment will be prospectively studied during 2-year period. All patients have HCV/HBV co-infection. The inclusion/exclusion criteria and the follow up plan will be listed in following part.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-02-01
• Primary completion: 2021-05-01
• Completion: 2021-08-01
• First posted: 2015-09-22
• Last updated: 2021-09-01

Locations

1 site across 1 country: China