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Controlled Interruption of Nucleos(t)ide Analogue Treatment in Chronic Hepatitis B Infections

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-511016-25-00
Enrollment
140
Registered
2025-01-15
Start date
2025-01-15
Completion date
Unknown
Last updated
2025-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic hepatitis B infection

Brief summary

The primary endpoint of this study is the occurrence of viral control defined as HBV DNA ≤2000 IU/mL and ALT ≤2xULN 72 weeks after treatment cessation.

Detailed description

The secondary endpoint of this study is HBsAg loss at week 72 after treatment cessation.

Interventions

DRUGVemlidy 25 mg film-coated tablets
DRUGTenofovir disoproxil Viatris 245 mg film-coated tablets
DRUGBaraclude 1 mg film-coated tablets
DRUGEntecavir Krka 1 mg filmomhulde tabletten
DRUGViread 245 mg film-coated tablets
DRUGBaraclude 0.5 mg film-coated tablets
DRUGEntecavir Krka 0
DRUG5 mg filmomhulde tabletten

Sponsors

Antwerp University Hospital
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint of this study is the occurrence of viral control defined as HBV DNA ≤2000 IU/mL and ALT ≤2xULN 72 weeks after treatment cessation.—

Secondary

MeasureTime frame
The secondary endpoint of this study is HBsAg loss at week 72 after treatment cessation.—

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026