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Trial record 93 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"

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

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ClinicalTrials.gov Identifier: NCT02555943
Recruitment Status : Recruiting
First Posted : September 22, 2015
Last Update Posted : March 5, 2019
Sponsor:
Collaborators:
Beijing 302 Hospital
Nanfang Hospital of Southern Medical University
Information provided by (Responsible Party):
George Lau, Humanity and Health Research Centre

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.

Condition or disease Intervention/treatment 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

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Direct Antiviral Agents for the Treatment of Chronic HCV/HBV Co-infection Patients
Actual Study Start Date : February 2015
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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).

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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®




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02555943


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

Locations
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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 and Health Research Centre
Beijing 302 Hospital
Nanfang Hospital of Southern Medical University
Investigators
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Principal Investigator: George Lau, M.D. Humanity and Health GI and Liver Centre

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Responsible Party: George Lau, Director, Humanity and Health Research Centre
ClinicalTrials.gov Identifier: NCT02555943     History of Changes
Other Study ID Numbers: H&H_DASCO
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Virus Diseases
RNA Virus Infections
DNA Virus Infections
Ledipasvir
Ledipasvir, sofosbuvir drug combination
Infection
Communicable Diseases
Coinfection
Hepatitis A
Hepatitis C
Hepatitis B
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Hepadnaviridae Infections
Hepatitis, Chronic
Parasitic Diseases
Ritonavir
Tenofovir
Sofosbuvir
Entecavir
Hepatitis C Antibodies
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors