HumRes66613
|
SNCTP000006341
|
BASEC2024-01986
|
NCT06887036
Methylene Blue in Patients with Chronic Hepatitis B Infection
Zusammenfassung der Studie
Study to evaluate the antiviral efficacy of Methylene Blue in patients affected by hepatitis B virus infection.
(BASEC)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
Hepatitis B Virus Infection
(BASEC)
Kriterien zur Teilnahme
Participation is open to individuals aged between 18 and 80 years, with chronic hepatitis B virus infection. (BASEC)
Ausschlusskriterien
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)
Ausschlusskriterien
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)
Studienstandort
Lugano
(BASEC)
Switzerland (ICTRP)
Sponsor
Fondazione Epatocentro Ticino
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Rossella Forlenza
+41 91 910 6570
rossella.forlenza@clutterhin.chFondazione Epatocentro Ticino
(BASEC)
Allgemeine Auskünfte
0041 91 910 65700041 91 910 6570
andreas.cerny@hin.chandreas.cerny@hin.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Tessin
(BASEC)
Datum der Bewilligung durch die Ethikkommission
23.12.2024
(BASEC)
ICTRP Studien-ID
NCT06887036 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Methylene Blue treatment of chronic Hepatitis B Virus infection: a pilot study (BASEC)
Wissenschaftlicher Titel
Methylene Blue Treatment of Chronic Hepatitis B Virus Infection: a Pilot Study (ICTRP)
Öffentlicher Titel
Methylene Blue Treatment of Chronic Hepatitis B Virus Infection (ICTRP)
Untersuchte Krankheit(en)
Chronic HBV Infection (ICTRP)
Untersuchte Intervention
Drug: Methylene Blue (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
Reduction >1 log10 in the starting HBsAg level and > 2 log10 in the starting HBV DNA PCR level (ICTRP)
Adverse Events;Treatment adherence (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Andreas CernyAndreas Cerny, andreas.cerny@hin.chandreas.cerny@hin.ch, 0041 91 910 65700041 91 910 6570 (ICTRP)
Sekundäre IDs
Methylene Blue in chronic HBV (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/study/NCT06887036 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar