HumRes66613
|
SNCTP000006341
|
BASEC2024-01986
|
NCT06887036
Methylene Blue in Patients with Chronic Hepatitis B Infection
Summary description of the study
Study to evaluate the antiviral efficacy of Methylene Blue in patients affected by hepatitis B virus infection.
(BASEC)
Intervention under investigation
Demographic data
Medical history
Physical examination
Weight and height
Blood pressure, heart rate, body temperature
Blood samples for hematology, chemistry, and virology
Urine pregnancy test
(BASEC)
Disease under investigation
Hepatitis B Virus Infection
(BASEC)
Criteria for participation in trial
Participation is open to individuals aged between 18 and 80 years, with chronic hepatitis B virus infection. (BASEC)
Exclusion criteria
Individuals with G-6-phosphatase deficiency (also commonly known as favism) and/or those who are being treated with a serotonergic drug are excluded from participation. (BASEC)
Participation is open to individuals aged between 18 and 80 years, with chronic hepatitis B virus infection. (BASEC)
Exclusion criteria
Individuals with G-6-phosphatase deficiency (also commonly known as favism) and/or those who are being treated with a serotonergic drug are excluded from participation. (BASEC)
Trial sites
Lugano
(BASEC)
Switzerland (ICTRP)
Sponsor
Fondazione Epatocentro Ticino
(BASEC)
Contact
Contact Person Switzerland
Rossella Forlenza
+41 91 910 6570
rossella.forlenza@clutterhin.chFondazione Epatocentro Ticino
(BASEC)
General Information
0041 91 910 65700041 91 910 6570
andreas.cerny@hin.chandreas.cerny@hin.ch(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Ticino
(BASEC)
Date of authorisation
23.12.2024
(BASEC)
ICTRP Trial ID
NCT06887036 (ICTRP)
Official title (approved by ethics committee)
Methylene Blue treatment of chronic Hepatitis B Virus infection: a pilot study (BASEC)
Academic title
Methylene Blue Treatment of Chronic Hepatitis B Virus Infection: a Pilot Study (ICTRP)
Public title
Methylene Blue Treatment of Chronic Hepatitis B Virus Infection (ICTRP)
Disease under investigation
Chronic HBV Infection (ICTRP)
Intervention under investigation
Drug: Methylene Blue (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion 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 (ICTRP)
not available
Primary and secondary end points
Reduction >1 log10 in the starting HBsAg level and > 2 log10 in the starting HBV DNA PCR level (ICTRP)
Adverse Events;Treatment adherence (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
Andreas CernyAndreas Cerny, andreas.cerny@hin.chandreas.cerny@hin.ch, 0041 91 910 65700041 91 910 6570 (ICTRP)
Secondary trial IDs
Methylene Blue in chronic HBV (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/study/NCT06887036 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available