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Completed

NCT Number: NCT02555943

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

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.

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Key information

Conditions

Chronic Hepatitis C Infection HBV Coinfection Hepatitis B Reactivation

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Humanity and Health GI and Liver Centre

Hong Kong, 00852, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ledipasvir/Sofosbuvir

Drug

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

sofosbuvir and daclatasvir

Drug

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

Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir

Drug

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™

Entecavir

Drug

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

Other names: BARACLUDE®

Tenofovir disoproxil

Drug

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

Other names: VIREAD®

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Humanity and Health Research Centre

Other

Collaborators

  • Beijing 302 Hospital
  • Nanfang Hospital, Southern Medical University

Registry information

Official study title

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

Acronym: DASCO

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Sep 22, 2015
Registry last updated
Sep 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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