NCT06887036

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
6mo left

Started Sep 2025

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress59%
Sep 2025Oct 2026

First Submitted

Initial submission to the registry

March 14, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 20, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Last Updated

August 17, 2025

Status Verified

August 1, 2025

Enrollment Period

1.2 years

First QC Date

March 14, 2025

Last Update Submit

August 13, 2025

Conditions

Chronic HBV Infection

Keywords

HBVchronic HBVMethylene BlueMB

Outcome Measures

Primary Outcomes (1)

  • 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).

    From enrollment to the end of treatment at 6 months

Secondary Outcomes (2)

  • Adverse Events

    From enrollment to the end of follow up period (12 months in total)

  • Treatment adherence

    From enrollment to the end of follow up period (12 months in total)

Study Arms (1)

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.

Drug: Methylene Blue

Interventions

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.

Methylene Blue

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Epatocentro Ticino

Lugano, Canton Ticino, 6900, Switzerland

RECRUITING

MeSH Terms

Interventions

Methylene Blue

Intervention Hierarchy (Ancestors)

PhenothiazinesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Andreas Cerny

CONTACT

0041 91 910 6570andreas.cerny@hin.ch

Chiara De Luca

CONTACT

0041 91 910 6570chiara.deluca@hin.ch

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2025

First Posted

March 20, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Last Updated

August 17, 2025

Record last verified: 2025-08

Locations

CH(1)