Status:
ACTIVE_NOT_RECRUITING
Halting Nucleoside Analogues in Chronic Hepatitis B
Lead Sponsor:
Seng Gee Lim
Collaborating Sponsors:
Tan Tock Seng Hospital
Singapore General Hospital
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
21-70 years
Phase:
NA
Brief Summary
Most patients with Chronic Hepatitis B are on nucleoside analogy (NA) long term, but this leads to HBsAg loss (defined as functional cure) of only 2% at 6 years. Recently a number of studies have show...
Detailed Description
Chronic Hepatitis B (CHB) affects over 250 million persons and is considered one of the major causes of mortality and morbidity globally. Standard treatment consists of nucleos(t)ide analogues (NA) or...
Eligibility Criteria
Inclusion
- • Between 21 and 75 years old.
- Documented to be HBsAg positive for ≥ 6 months.
- On any NA (lamivudine, adefovir, entecavir, telbivudine tenofovir) for ≥ 1 year
- HBV DNA \<15 IU/ml at screening (undetectable)
- Quantitative HBsAg \<100 IU/ml
- Patient has agreed not to take any other investigational drug or systemic anti-viral, cytotoxic, corticosteroid, immunomodulatory agents or Chinese traditional remedies unless clinically indicated.
- Patient is able to give written consent prior to study start and to comply with the study requirements.
- Women of childbearing age must have a negative serum (ß-HCG) pregnancy test taken with 14 days of starting therapy
Exclusion
- • Evidence of liver cirrhosis based on liver biopsy, fibroscan score \>10.5 kpa, or MRE score\>5.5kpa, or clinical evidence of cirrhosis demonstrated by presence of esophageal varices, obvious features of cirrhosis on ultrasound within the last 12 months
- Evidence of decompensated liver disease or hepatocellular carcinoma.
- HIV antibody or HCV antibody or HDV antibody positivity
- Creatinine \> 1.5 times upper limit of normal
- INR \> 1.5, uncorrected by Vitamin K therapy.
- Any interferon, Immunomodulators, systemic cytotoxic agents, or systemic corticosteroids within 6 months before trial entry.
- Prolonged exposure to known hepatotoxins such as alcohol or drugs.
- History of clinically relevant psychiatric disease, seizures, central nervous system dysfunction, severe pre-existing cardiac, renal, hematological disease or medical illness that in the investigator's opinion might interfere with therapy.
- Malignant disease within 5 years of trial entry.
- Women who are pregnant and who are not practicing adequate birth control measures, or who are lactating
Key Trial Info
Start Date :
January 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04102176
Start Date
January 29 2019
End Date
February 1 2026
Last Update
July 14 2025
Active Locations (1)
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1
National University Hospital
Singapore, Singapore, 119228