Status:
UNKNOWN
NUC in Preventing HBV Reactivation in HCV/HBV Co-infected Patients Receiving DAA for CHC
Lead Sponsor:
National Taiwan University Hospital
Conditions:
HBV/HCV Co-infection
Eligibility:
All Genders
20-70 years
Phase:
NA
Brief Summary
HBV reactivation is common in HCV/HBV coinfected patients receiving DAA therapy for chronic hepatitis C. How to prevent HBV reactivation remains unclear. In this trial, we aim to investigate whether p...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 28 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04405011
Start Date
August 1 2018
End Date
December 28 2020
Last Update
July 2 2020
Active Locations (2)
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1
National Taiwan University Hospital
Taipei, Taiwan, 100
2
TC Chen
Taipei, Taiwan, 100