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

August 27, 2021 updated by: George Lau, Humanity and Health Research Centre

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hong Kong
      • Hong Kong, Hong Kong, China, 00852
        • Humanity and Health GI and Liver Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Prophylactic/Early anti-HBV treatment

HCV/HBV co-infection patients in this arm will receive nucleos(t)ides analog (Entecavir or Tenofovir disoproxil fumarate) for the treatment of hepatitis B infection before or at the commencement of direct anti-HCV treatment using DAAs (Ledipasvir/Sofosbuvir; or Sofosbuvir and Daclatasvir, or Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir; or Sofosbuvir+Ribavirin).

.
Drug: Ledipasvir/Sofosbuvir
Oral direct anti-HCV agent. Ledipasvir/Sofosbuvir(LDV/SOF) 400mg/90mg fixed-dose combination(FDC) tablet, administered orally once daily.
Other Names:
  • Harvoni®
  • GS-7977
  • GS-5885
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.
Other Names:
  • Sovaldi®, GS-7977
  • Daklinza®,BMS-790052
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.
Other Names:
  • VIEKIRA PAK™
Drug: Entecavir
Nucleoside-inhibitor-treatment-naïve with compensated liver disease (greater than or equal to 16 years old): 0.5 mg once daily.
Other Names:
  • BARACLUDE®
Drug: Tenofovir disoproxil
VIREAD is indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older.
Other Names:
  • VIREAD®
EXPERIMENTAL: Deferred anti-HBV treatment
HCV/HBV co-infection patients in this arm will receive nucleos(t)ides analog (Entecavir or Tenofovir disoproxil fumarate) for the treatment of hepatitis B infection when HBV viral breakthrough occurred during anti-HCV treatment using DAAs (Ledipasvir/Sofosbuvir; or Sofosbuvir and Daclatasvir, or Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir; or Sofosbuvir+Ribavirin).
Drug: Ledipasvir/Sofosbuvir
Oral direct anti-HCV agent. Ledipasvir/Sofosbuvir(LDV/SOF) 400mg/90mg fixed-dose combination(FDC) tablet, administered orally once daily.
Other Names:
  • Harvoni®
  • GS-7977
  • GS-5885
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.
Other Names:
  • Sovaldi®, GS-7977
  • Daklinza®,BMS-790052
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.
Other Names:
  • VIEKIRA PAK™
Drug: Entecavir
Nucleoside-inhibitor-treatment-naïve with compensated liver disease (greater than or equal to 16 years old): 0.5 mg once daily.
Other Names:
  • BARACLUDE®
Drug: Tenofovir disoproxil
VIREAD is indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older.
Other Names:
  • VIREAD®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants who experience virological breakthrough
Time Frame: From the commencement of DAAs treatment to 12 weeks post DAAs treatment
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
Proportion of participants who experience virological rebound
Time Frame: From the commencement of DAAs treatment to 12 weeks post DAAs treatment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participant who experience biochemical rebound
Time Frame: From the commencement of DAAs treatment to 12 weeks post DAAs treatment
Biochemical rebound is defined as
From the commencement of DAAs treatment to 12 weeks post DAAs treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participant who experience liver failure
Time Frame: From the commencement of DAAs treatment to 12 weeks post DAAs treatment
Diagnosis of liver failure
From the commencement of DAAs treatment to 12 weeks post DAAs treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Humanity and Health Research Centre

Collaborators

Beijing 302 Hospital
Nanfang Hospital of Southern Medical University

Investigators

  • Principal Investigator: George Lau, M.D., Humanity and Health GI and Liver Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2015

Primary Completion (ACTUAL)

May 1, 2021

Study Completion (ACTUAL)

August 1, 2021

Study Registration Dates

First Submitted

September 20, 2015

First Submitted That Met QC Criteria

September 20, 2015

First Posted (ESTIMATE)

September 22, 2015

Study Record Updates

Last Update Posted (ACTUAL)

September 1, 2021

Last Update Submitted That Met QC Criteria

August 27, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H&H_DASCO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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