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New treatment option for Chronic HBV Infection
Official title Methylene Blue Treatment of Chronic Hepatitis B Virus Infection
ClinicalTrials.gov ID: NCT06887036
What this study is testing
What is Methylene Blue?
Methylene Blue is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chronic hbv infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 79
You may be able to join 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
You likely can't join 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Lugano, Canton Ticino, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lugano, Canton Ticino, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.