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Study identifier: NCT06887036 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Methylene Blue Treatment of Chronic Hepatitis B Virus Infection

Condition: Chronic HBV Infection  ·  Sponsor: Fondazione Epatocentro Ticino

PhasePhase 2
Planned participants10
Who can joinAll sexes, 18 Years to 79 Years
Healthy volunteersNo

About this 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. 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…

This description comes directly from the study's public registry record.

Talk to the study team

Andreas Cerny  ·  0041 91 910 6570  ·  andreas.cerny@hin.ch

Chiara De Luca  ·  0041 91 910 6570  ·  chiara.deluca@hin.ch

Always discuss trial participation with your own doctor first.

Locations (1)

Epatocentro TicinoLugano, Canton Ticino, SwitzerlandRecruiting

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Source record: clinicaltrials.gov/study/NCT06887036