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HepBTer: From fungus to virus, a phase 2a clinical trial investigating the safety and efficacy of terbinafine in chronic hepatitis B patients

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514888-25-00
Enrollment
32
Registered
2024-07-25
Start date
2024-07-25
Completion date
2025-08-21
Last updated
2024-07-25

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

Conditions

Chronic hepatitis B

Brief summary

- Decline in level of serum HBsAg >0.32log10 IU/mL in both groups A and B (week 10 vs baseline) - Decline in serum HBV DNA >0.86log10 in group A at the end of study treatment (week 10 vs baseline)

Detailed description

- Safety and tolerability of terbinafine as mono- or combination therapy.

Interventions

DRUGPlacebo Terbinafine 250 mg capsules
DRUGTerbinafine Mylan 250 mg
DRUGtabletten

Sponsors

Stichting Amsterdam UMC
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
- Decline in level of serum HBsAg >0.32log10 IU/mL in both groups A and B (week 10 vs baseline) - Decline in serum HBV DNA >0.86log10 in group A at the end of study treatment (week 10 vs baseline)—

Secondary

MeasureTime frame
- Safety and tolerability of terbinafine as mono- or combination therapy.—

Countries

Netherlands

Outcome results

None listed

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