Status:
RECRUITING
Methylene Blue Treatment of Chronic Hepatitis B Virus Infection
Lead Sponsor:
Fondazione Epatocentro Ticino
Conditions:
Chronic HBV Infection
Eligibility:
All Genders
18-79 years
Phase:
PHASE2
Brief Summary
HBV infection is a global public health problem. It is estimated that there are more than 250 million HBV carriers worldwide, of whom approximately 600,000 die each year from HBV-related liver disease...
Eligibility Criteria
Inclusion
- Signed informed consent
- Age ≥ 18 and \< 80 years
- Microbiologically confirmed chronic Hepatitis B Virus infection (according to the old terminology "inactive HBV carrier")
- HBsAg levels within 20-15'000 IU/ml measured at the at least twice at 6-18 months apart
- HBV DNA PCR levels within 1'000-20'000 IU/ml measured at least twice at 6-18 months apart
- Negative pregnancy test in women of child-bearing age
Exclusion
- Documented refusal to participate in the study
- Known G-6-Phophatase deficiency
- Treatment with a serotoninergic drug
- Ongoing treatment with a nucleos(-t)ide treatment
- Clinically relevant concomitant liver disease
- GPT \> 2xULN
- Fibroscan of \> 8.0 KPa obtained ≤ 12 months before Visit 0/Screening
- HBeAg positivity
- Anti HDV antibody positivity
- Breastfeeding women
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06887036
Start Date
September 1 2025
End Date
October 31 2026
Last Update
August 17 2025
Active Locations (1)
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1
Epatocentro Ticino
Lugano, Canton Ticino, Switzerland, 6900