Status:
ACTIVE_NOT_RECRUITING
COIN-B: COntrolled Interruption of Nucleos(t)Ide Analogue Treatment in Chronic Hepatitis B Infections
Lead Sponsor:
University Hospital, Antwerp
Collaborating Sponsors:
Universiteit Antwerpen
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
In this study we will prospectively stop NA in both Caucasian and non-Caucasian patients matched for gender and age, to validate the observed host and viral parameters for future roll-out of this trea...
Detailed Description
An estimated 290 million people worldwide are chronically infected with the Hepatitis B Virus (HBV). One fourth of untreated patients develop progressive liver damage and are at risk of liver-related ...
Eligibility Criteria
Inclusion
- Chronic hepatitis B
- Under continuous NA treatment
- \>= 18 years old and \<= 75 years
- HBeAg negative at start of treatment
- HBV DNA undetectable \>36 months or \<100 IU/mL \>48 months
- ALT \<= 80 U/L
Exclusion
- Fibrosis \>F2
- Active coinfection with HCV, HDV or HIV
- Pregnancy or lactation
- Immunocompromised patients
- Ever HCC or family history of HCC
- Ever participated in HBV siRNA therapeutic trials
Key Trial Info
Start Date :
July 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT04779970
Start Date
July 28 2021
End Date
December 1 2025
Last Update
June 24 2024
Active Locations (26)
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1
ASZ Aalst
Aalst, Belgium
2
ZNA Stuivenberg
Antwerp, Belgium, 2060
3
Antwerp University Hospital
Antwerp, Belgium, 2650
4
GZA Antwerp
Antwerp, Belgium