Methylene Blue Treatment of Chronic Hepatitis B Virus Infection

NCT ID: NCT06887036

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2026-10-31

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. 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Methylene Blue

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.

Group Type: EXPERIMENTAL

Methylene Blue

Intervention Type: DRUG

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.

Interventions

Methylene Blue

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Epatocentro Ticino

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Epatocentro Ticino

Lugano, Canton Ticino, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Andreas Cerny

Role: CONTACT

andreas.cerny@hin.ch

0041 91 910 6570

Chiara De Luca

Role: CONTACT

chiara.deluca@hin.ch

0041 91 910 6570

Facility Contacts

Andreas Cerny

Role: primary

andreas.cerny@hin.ch

0041 91 910 6570

Other Identifiers

Methylene Blue in chronic HBV

Identifier Type: -

Identifier Source: org_study_id