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

Primary Purpose

Chronic Hepatitis C Infection, HBV Coinfection, Hepatitis B Reactivation

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Ledipasvir/Sofosbuvir
Sofosbuvir and Daclatasvir
Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir
Entecavir
Tenofovir disoproxil
Sponsored by
Humanity and Health Research Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C Infection

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Humanity and Health GI and Liver Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Prophylactic/Early anti-HBV treatment

Deferred anti-HBV treatment

Arm Description

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). .

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).

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Proportion of participant who experience biochemical rebound
Biochemical rebound is defined as

Full Information

First Posted
September 20, 2015
Last Updated
August 27, 2021
Sponsor
Humanity and Health Research Centre
Collaborators
Beijing 302 Hospital, Nanfang Hospital, Southern Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02555943
Brief Title
DAAs Treatment for Chronic HCV/HBV Co-infection Patients(DASCO)
Acronym
DASCO
Official Title
Direct Antiviral Agents for the Treatment of Chronic HCV/HBV Co-infection Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
May 2021 (Actual)
Study Completion Date
August 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Humanity and Health Research Centre
Collaborators
Beijing 302 Hospital, Nanfang Hospital, Southern Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C Infection, HBV Coinfection, Hepatitis B Reactivation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prophylactic/Early anti-HBV treatment
Arm Type
Active Comparator
Arm Description
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). .
Arm Title
Deferred anti-HBV treatment
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Ledipasvir/Sofosbuvir
Other Intervention Name(s)
Harvoni®, GS-7977, GS-5885
Intervention Description
Oral direct anti-HCV agent. Ledipasvir/Sofosbuvir(LDV/SOF) 400mg/90mg fixed-dose combination(FDC) tablet, administered orally once daily.
Intervention Type
Drug
Intervention Name(s)
Sofosbuvir and Daclatasvir
Other Intervention Name(s)
Sovaldi®, GS-7977, Daklinza®,BMS-790052
Intervention Description
TWO oral direct anti-HCV agent: Sofosbuvir(SOF), 400mg tablet administered orally once daily. Daclatavir(DCV), 60mg tablet administered orally once daily.
Intervention Type
Drug
Intervention Name(s)
Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir
Other Intervention Name(s)
VIEKIRA PAK™
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Entecavir
Other Intervention Name(s)
BARACLUDE®
Intervention Description
Nucleoside-inhibitor-treatment-naïve with compensated liver disease (greater than or equal to 16 years old): 0.5 mg once daily.
Intervention Type
Drug
Intervention Name(s)
Tenofovir disoproxil
Other Intervention Name(s)
VIREAD®
Intervention Description
VIREAD is indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older.
Primary Outcome Measure Information:
Title
Proportion of participants who experience virological breakthrough
Description
Virological breakthrough is defined as 1 logIU/ml increase during and/or post DAAs treatment for the baseline or nadir.
Time Frame
From the commencement of DAAs treatment to 12 weeks post DAAs treatment
Title
Proportion of participants who experience virological rebound
Description
Virological rebound is defined as 2 logIU/ml increase during and/or post DAAs treatment for the baseline or nadir.
Time Frame
From the commencement of DAAs treatment to 12 weeks post DAAs treatment
Secondary Outcome Measure Information:
Title
Proportion of participant who experience biochemical rebound
Description
Biochemical rebound is defined as
Time Frame
From the commencement of DAAs treatment to 12 weeks post DAAs treatment
Other Pre-specified Outcome Measures:
Title
Proportion of participant who experience liver failure
Description
Diagnosis of liver failure
Time Frame
From the commencement of DAAs treatment to 12 weeks post DAAs treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Lau, M.D.
Organizational Affiliation
Humanity and Health GI and Liver Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Humanity and Health GI and Liver Centre
City
Hong Kong
State/Province
Hong Kong
ZIP/Postal Code
00852
Country
China

12. IPD Sharing Statement

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

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