- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04405011
NUC in Preventing HBV Reactivation in HCV/HBV Co-infected Patients Receiving DAA for CHC
Role of Nucleoside Analogue in Preventing Clinical Reactivation of HBV in HCV/HBV Co-infected Patients Receiving DAA Therapy for Chronic Hepatitis C
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
We will determine the incidence of virologic and clinical reactivation of HBV during DAA treatment for CHC, in two prophylactic groups versus control group. We will also examine whether extending the duration of prophylactic NUC would be more beneficial than the 3-month prophylaxis regimen.
Patients with the following criteria will be enrolled: age ≥20 years; anti-HCV positive and HCV RNA >1000 IU/ml; any HCV genotype; all received 12 weeks of DAA treatment; treatment naïve or experienced of pegylated interferon/ribavirin; concurrent HBV infection which is defined by positive HBsAg for at least 6 months. Patients with the following criteria will be excluded: history of treatment regimen that included any kind of direct antiviral agents; presence of other etiology of chronic hepatitis including HIV, autoimmune hepatitis, NASH, etc; uncontrolled diabetes mellitus (Hba1c >8.5); current evidence or suspicion of malignancy; severe cardiovascular or other severe comorbid diseases; autoimmune disorders; presence of liver cirrhosis clinically or pathologically; any one of following hematology or biochemical or clinical abnormalities: AST/ALT >10x ULN, Albumin <3.5g/dL, Bilirubin >2.5mg/dL, eGFR <30 ml/min/1.73m2, prothrombin time prolongation >4 sec or INR >1.7, platelet count <100 x 103 uL, and history or presence of ascites or hepatic encephalopathy; child-bearing age women without the willing to contraceptive control; and pregnant women or lactating women.
Briefly, 60 HCV/HBV coinfected patients will be enrolled and randomized to receive 12-week DAA regimen for reimbursed for the the treatment of patients with CHC in Taiwan.
Entecavir (0.5mg; ETV) 1 # daily will be used in the prophylactic group. Group 1 patients (n=20) will receive 12-week ETV from the start of DAA therapy. Group 2 patients (n=20) will receive 24-week ETV from the start of DAA till 12 weeks after end of DAA. Group 3 patients (n=20) will not receive ETV during the period of DAA and serve as controls. The rate of HBV reactivation and clinical reactivation will be compared among 3 groups of patients.
The primary endpoint will be the incidence of virologic and clinical reactivation of HBV during DAA treatment for CHC. Secondary objectives include the rate of HBV virologic and clinical reactivation between 12-week versus 24-week entecavir (ETV) prophylaxis during and after DAA treatment; the profiles of serum HBV DNA/qHBsAg during and after DAA treatment; and sustained virological response at post-DAA treatment 12 weeks (SVR12).
The data will be expressed as percentages for category variables and as mean +- standard deviation for continuous variables. Category variables will be evaluated by Chi-square test or Fisher exact test. Student's t test or Mann-Whitney U test will be applied for comparison of the continuous variables. Multivariate analysis will be used to identify factors that are associated with HBV reactivation. A p value less than 0.05 is considered to be significant.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chun-Jen Liu
- Phone Number: 0972651071
- Email: cjliu@ntu.edu.tw
Study Contact Backup
- Name: Ting-Chih Chen
- Phone Number: 0920228525
- Email: tingchih@g.ntu.edu.tw
Study Locations
-
-
-
Taipei, Taiwan, 100
- Recruiting
- TC Chen
-
Taipei City, Taiwan, 100
- Recruiting
- National Taiwan University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria
- Age ≥20 years;
- Anti-HCV positive and HCV RNA >1000 IU/ml;
- Any HCV genotype; all received 12 weeks of DAA treatment.
- Treatment naïve or experienced of pegylated interferon/ribavirin;
- Concurrent HBV infection which is defined by positive HBsAg for at least 6 months.
Exclusion criteria
- History of treatment regimen that included any kind of direct antiviral agents;
- Presence of other etiology of chronic hepatitis including HIV, autoimmune hepatitis, NASH, etc;
- Uncontrolled diabetes mellitus (Hba1c >8.5);
- Current evidence or suspicion of malignancy;
- Severe cardiovascular or other severe comorbid diseases;
- Autoimmune disorders;
- Presence of liver cirrhosis clinically or pathologically;
Any one of following hematology or biochemical or clinical abnormalities:
AST/ALT >10x ULN, Albumin <3.5g/dL, Bilirubin >2.5mg/dL, eGFR <30 ml/min/1.73m2, prothrombin time prolongation >4 sec or INR >1.7, platelet count <100 x 103 uL, and history or presence of ascites or hepatic encephalopathy.
- Child-bearing age women without the willing to contraceptive control; pregnant women or lactating women.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Entecavir 0.5mg daily for 24 weeks
Entecavir will be delivered for 24-week and will be the experimental arm
|
Entecavir 0.5mg for 24 weeks will be delivered
Other Names:
|
ACTIVE_COMPARATOR: Entecavir 0.5mg daily for 12 weeks
12-week entecavir will be served as active comparator
|
Entecavir for 12 weeks will be delivered and serve as the active comparator arm
Other Names:
|
NO_INTERVENTION: Control
Control group does not receive prophylactic ETV
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HBV virologic and clinical reactivation rates
Time Frame: 72 weeks
|
The primary endpoint will be the incidence of virologic and clinical reactivation of HBV during DAA treatment for CHC.
|
72 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HBV reactivation rate: 12-week prophylaxis versus 24-week prophylaxis
Time Frame: 72 weeks
|
12 weeks or 24 weeks of ETV prophylaxis in the control of HBV activity during and after DAA treatment
|
72 weeks
|
Profiles of serum HBV DNA/qHBsAg during and after DAA treatment.
Time Frame: 72 weeks
|
The profiles of HBV DNA and qHBsAg will be compared among 3 study groups
|
72 weeks
|
Sustained virological response at post-DAA treatment 12 weeks (SVR12)
Time Frame: 72 weeks
|
The SVR12 will be compared among 3 study groups
|
72 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Chun-Jen Liu, MDPHD, Department of Internal Medicine, NTUH
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201807069MINB
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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