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Trial record 157 of 350 for:    hepatitis b | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Humanity & Healthy GI and Liver Centre
Sponsor:
Collaborators:
Beijing 302 Hospital
Nanfang Hospital of Southern Medical University
Information provided by (Responsible Party):
George Lau, Humanity & Healthy GI and Liver Centre
ClinicalTrials.gov Identifier:
NCT02555943
First received: September 20, 2015
Last updated: August 18, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention Phase
Chronic Hepatitis C Infection
HBV Coinfection
Hepatitis B Reactivation
Drug: Ledipasvir/Sofosbuvir
Drug: Sofosbuvir and Daclatasvir
Drug: Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir
Drug: Entecavir
Drug: Tenofovir disoproxil
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Direct Antiviral Agents for the Treatment of Chronic HCV/HBV Co-infection Patients

Resource links provided by NLM:


Further study details as provided by Humanity & Healthy GI and Liver Centre:

Primary Outcome Measures:
  • 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.

  • 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 Outcome Measures:
  • 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 Outcome Measures:
  • 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


Estimated Enrollment: 32
Study Start Date: February 2015
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: VIREAD®

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02555943

Contacts
Contact: Cheng Wang, M.D. PhD (852)28613777 doc_chengwang@126.com
Contact: George Lau, M.D. (852)28613777 gkklau@netvigator.com

Locations
China, Hong Kong
Humanity and Health GI and Liver Centre Recruiting
Hong Kong, Hong Kong, China, 00852
Contact: Cheng Wang, M.D. PhD    (852)28613777    doc_chengwang@126.com   
Contact: Yudong Wang    (852)28613777    ydwang@connect.hku.hk   
Sponsors and Collaborators
Humanity & Healthy GI and Liver Centre
Beijing 302 Hospital
Nanfang Hospital of Southern Medical University
Investigators
Principal Investigator: George Lau, M.D. Humanity and Health GI and Liver Centre
  More Information

Responsible Party: George Lau, Director, Humanity & Healthy GI and Liver Centre
ClinicalTrials.gov Identifier: NCT02555943     History of Changes
Other Study ID Numbers: H&H_DASCO 
Study First Received: September 20, 2015
Last Updated: August 18, 2016

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis B
Hepatitis C, Chronic
Hepatitis, Viral, Human
Hepatitis C Antibodies
Infection
Communicable Diseases
Coinfection
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepadnaviridae Infections
DNA Virus Infections
Parasitic Diseases
Tenofovir
Ritonavir
Sofosbuvir
Ledipasvir, sofosbuvir drug combination
Ledipasvir
Entecavir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this record on February 23, 2017