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

Chronic Hepatitis C Infection Clinical Trial

— DASCO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02555943
• Other study ID #: H&H_DASCO
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 2015
• Est. completion date: August 2021

Study information

• Verified date: August 2021
• Source: Humanity and Health Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: August 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis C Infection
• Coinfection
• Communicable Diseases
• HBV Coinfection
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B Reactivation
• Hepatitis C
• Hepatitis C, Chronic
• Infection

Intervention

Drug:
• Ledipasvir/Sofosbuvir
Oral direct anti-HCV agent. Ledipasvir/Sofosbuvir(LDV/SOF) 400mg/90mg fixed-dose combination(FDC) tablet, administered orally once daily.
• 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.
• 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.
• Entecavir
Nucleoside-inhibitor-treatment-naïve with compensated liver disease (greater than or equal to 16 years old): 0.5 mg once daily.
• Tenofovir disoproxil
VIREAD is indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older.

Locations

Country	Name	City	State
China	Humanity and Health GI and Liver Centre	Hong Kong	Hong Kong

Sponsors (3)

Lead Sponsor	Collaborator
Humanity and Health Research Centre	Beijing 302 Hospital, Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of participant who experience liver failure	Diagnosis of liver failure	From the commencement of DAAs treatment to 12 weeks post DAAs treatment
Primary	Proportion of participants who experience virological breakthrough	Virological breakthrough is defined as 1 logIU/ml increase during and/or post DAAs treatment for the baseline or nadir.	From the commencement of DAAs treatment to 12 weeks post DAAs treatment
Primary	Proportion of participants who experience virological rebound	Virological rebound is defined as 2 logIU/ml increase during and/or post DAAs treatment for the baseline or nadir.	From the commencement of DAAs treatment to 12 weeks post DAAs treatment
Secondary	Proportion of participant who experience biochemical rebound	Biochemical rebound is defined as	From the commencement of DAAs treatment to 12 weeks post DAAs treatment