Methylene Blue treatment for chronic Hepatitis B infection
Official title: Methylene Blue Treatment of Chronic Hepatitis B Virus Infection: a Pilot Study
Run by Fondazione Epatocentro Ticino · NCT06887036 · Data updated 2026-11-12
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 | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Fondazione Epatocentro Ticino Academic / other |
| Locations | 1 site (Lugano, Canton Ticino) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | May 31, 2027 |
| Study ends | May 31, 2027 |
| Registry record updated | August 21, 2026 |
| Trial ID | NCT06887036 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 80 with microbiologically confirmed chronic Hepatitis B infection and specific HBsAg and HBV DNA levels.
✕Probably not a fit
Patients with HBeAg positivity, significant liver disease, or those currently on nucleos(-t)ide treatment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While the use of Methylene Blue in this context is novel, previous studies have shown promise in reducing viral loads in other infections.
Who can join: the full rules
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 it's running
-
Epatocentro Ticino
Lugano, Canton Ticino, Switzerland Recruiting
Study contacts
- Study coordinator: Andreas Cerny
- Email: andreas.cerny@hin.ch
- Phone: 0041 91 910 6570
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
LW231 treatment for people with chronic hepatitis B
This trial tests whether LW231, given alone or with standard antiviral NUCs, is safe and can lower hepatitis B virus measures in adults with chronic HBV.
-
Prospective NAFLD/NASH patient cohort and biobank
This project will collect medical data and blood/tissue samples from adults with NAFLD/NASH to create a long-term resource to help researchers understand disease course and causes.
-
Swiss Primary Sclerosing Cholangitis Cohort
This project will collect blood and other biological samples plus health information from people with primary sclerosing cholangitis in Switzerland to try to better understand the disease course and treatment responses.
-
Swiss Primary Biliary Cholangitis Cohort
This project will collect medical information and yearly blood samples from adults in Switzerland with primary biliary cholangitis to help understand its course and outcomes.
-
Swiss autoimmune hepatitis cohort
This project collects yearly health information and blood samples from people in Switzerland with autoimmune hepatitis to learn about the disease, treatments, and outcomes.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.