Methylene Blue treatment for chronic Hepatitis B infection
Methylene Blue Treatment of Chronic Hepatitis B Virus Infection: a Pilot Study
PHASE2 · Fondazione Epatocentro Ticino · NCT06887036
This study tests if Methylene Blue can help adults with chronic Hepatitis B lower their virus levels enough to stop taking antiviral medication.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | Fondazione Epatocentro Ticino (other) |
| Locations | 1 site (Lugano, Canton Ticino) |
| Trial ID | NCT06887036 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of Methylene Blue (MB) as a treatment for chronic Hepatitis B Virus (HBV) infection. The study aims to determine if MB can effectively reduce HBsAg levels, potentially allowing patients to stop antiviral treatment. Participants will be monitored for their HBV DNA levels and HBsAg levels over time to assess the treatment's efficacy. The trial includes adults aged 18 to 80 with confirmed chronic HBV infection who meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with microbiologically confirmed chronic Hepatitis B infection and specific HBsAg and HBV DNA levels.
Not a fit: Patients with HBeAg positivity, significant liver disease, or those currently on nucleos(-t)ide treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enable patients to achieve HBsAg negativity and discontinue lifelong antiviral therapy.
How similar studies have performed: While the use of Methylene Blue in this context is novel, previous studies have shown promise in reducing viral loads in other infections.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Lugano, Canton Ticino
- Epatocentro Ticino — Lugano, Canton Ticino, Switzerland (RECRUITING)
Study contacts
- Study coordinator: Andreas Cerny
- Email: andreas.cerny@hin.ch
- Phone: 0041 91 910 6570
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic HBV Infection, HBV, chronic HBV, Methylene Blue, MB