Chronic HBV InfectionPhase 2MB_HBVNCT06887036
Methylene Blue Treatment of Chronic Hepatitis B Virus Infection
A Phase 2 study testing Methylene Blue in people with Chronic HBV Infection, run by Fondazione Epatocentro Ticino at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Chronic HBV Infection
- What is being tested?
- Methylene Blue
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2025to 31 May 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Fibroscan of > 8.0 KPa obtained ≤ 12 months before Visit 0/Screening
- HBeAg positivity
- Anti HDV antibody positivity
- Breastfeeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Epatocentro Ticino
Lugano, Canton Ticino, 6900
Andreas Cerny, 0041 91 910 6570, andreas.cerny@hin.ch
About this study
Official title: Methylene Blue Treatment of Chronic Hepatitis B Virus Infection: a Pilot Study
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. Diagnosis and treatment depend on the stage of infection, the degree of liver inflammation, and the progression of fibrosis. Patients with HBeAg-positive or -negative hepatitis are usually treated with nucleos(-t)ide analogues. This treatment inhibits HBV reverse transcriptase and reduces viral replication, but does not affect HBsAg production. Treatment must be continued for life in most cases and is associated with high cumulative costs and the risk of development of resistance.
Recently, it has been shown that patients who show a decrease in their HBsAg levels are more likely to become HBsAg negative, seroconvert and be able to stop antiviral treatment, which is the ultimate goal of treatment, but unfortunately rarely achieved. Methylene blue (MB) has been shown to have an effect on HBsAg levels in vitro, making it a promising test for a new treatment for HBV.
Read more
This is an explorative pilot study, open label, dose-escalation, single center clinical trial on the efficacy of MB against HBV infection.
Primary objective is to assess the efficacy of incremental doses of MB against hepatitis B virus in patients with chronic hepatitis B assessed by the reduction of both the HBsAg and HBV DNA levels after 6 months of treatment and 6 months of follow-up.
Participant will be treated for 6 months with MB 100 mg capsules, and then followed up for a further 6 months. The initial dose of MB might be increased if the patient is a non-responder.
- Conditions
- Chronic HBV Infection
- Being tested
- Methylene Blue
- Keywords
- HBV, chronic HBV, Methylene Blue, MB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylene BlueDrug
Subjects will be initially treated with an initial dose of 200mg/day for 8 weeks at which point the investigators will assess the effect of the treatment.
Those patients that obtain a "complete response" will continue their treatment up to a total of 24 weeks with the same dose. Those who do not reach a "complete response" will be exposed to the next higher dose of 400mg/day for the following 8 weeks and the investigators will then again assess the effect of the treatment.
Those patients that obtain a "complete response" will continue their treatment up to a total of 24 weeks with the same dose. Those who do not reach a "complete response" will be exposed to the next higher dose of 600mg/day for the following 8 weeks and the investigators will then assess the effect of the treatment.
| Study group | Role | What they receive |
|---|---|---|
| Methylene Blue | Experimental | Subjects will be initially treated with an initial dose of 200mg/day for 8 weeks at which point the investigators will assess the effect of the treatment.
Those patients that obtain a "complete response" will continue their treatment up to a total of 24 weeks with the same dose. Those who do not reach a "complete response" will be exposed to the next higher dose of 400mg/day for the following 8 weeks and the investigators will then again assess the effect of the treatment.
Those patients that obtain a "complete response" will continue their treatment up to a total of 24 weeks with the same dose. Those who do not reach a "complete response" will be exposed to the next higher dose of 600mg/day for the following 8 weeks and the investigators will then assess the effect of the treatment. Receives: Drug: Methylene Blue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction >1 log10 in the starting HBsAg level and > 2 log10 in the starting HBV DNA PCR level
Primary endpoints have been created according to the levels of HBsAg and HBV DNA PCR. The main primary endpoint is the reduction >1 log10 in the starting HBsAg level and > 2 log10 in the starting HBV DNA PCR level after 6 months of treatment (complete response).
Measured: From enrollment to the end of treatment at 6 months
Secondary outcomes (2)
Adverse Events
Adverse Events during both the 6 months treatment period and the 6 months follow-up period after the treatment
Measured: From enrollment to the end of follow up period (12 months in total)
Treatment adherence
Assessment of treatment adherence, through IMP accountability
Measured: From enrollment to the end of follow up period (12 months in total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start1 Sep 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic HBV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Epatocentro Ticino
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887036
- Sponsor's protocol ID
- Methylene Blue in chronic HBV
- Acronym
- MB_HBV
- Status last verified
- Aug 2026
- First submitted
- 14 Mar 2025
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No