HumRes66613
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SNCTP000006341
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BASEC2024-01986
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NCT06887036
Methylene Blue in Patients with Chronic Hepatitis B Infection
Descrizione riassuntiva dello studio
Study to evaluate the antiviral efficacy of Methylene Blue in patients affected by hepatitis B virus infection.
(BASEC)
Intervento studiato
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)
Malattie studiate
Hepatitis B Virus Infection
(BASEC)
Criteri di partecipazione
Participation is open to individuals aged between 18 and 80 years, with chronic hepatitis B virus infection. (BASEC)
Criteri di esclusione
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)
Criteri di esclusione
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)
Luogo dello studio
Lugano
(BASEC)
Switzerland (ICTRP)
Sponsor
Fondazione Epatocentro Ticino
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Rossella Forlenza
+41 91 910 6570
rossella.forlenza@clutterhin.chFondazione Epatocentro Ticino
(BASEC)
Informazioni generali
0041 91 910 65700041 91 910 6570
andreas.cerny@hin.chandreas.cerny@hin.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Ticino
(BASEC)
Data di approvazione del comitato etico
23.12.2024
(BASEC)
ID di studio ICTRP
NCT06887036 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Methylene Blue treatment of chronic Hepatitis B Virus infection: a pilot study (BASEC)
Titolo accademico
Methylene Blue Treatment of Chronic Hepatitis B Virus Infection: a Pilot Study (ICTRP)
Titolo pubblico
Methylene Blue Treatment of Chronic Hepatitis B Virus Infection (ICTRP)
Malattie studiate
Chronic HBV Infection (ICTRP)
Intervento studiato
Drug: Methylene Blue (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
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)
non disponibile
Endpoint primari e secondari
Reduction >1 log10 in the starting HBsAg level and > 2 log10 in the starting HBV DNA PCR level (ICTRP)
Adverse Events;Treatment adherence (ICTRP)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
Andreas CernyAndreas Cerny, andreas.cerny@hin.chandreas.cerny@hin.ch, 0041 91 910 65700041 91 910 6570 (ICTRP)
ID secondari
Methylene Blue in chronic HBV (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/study/NCT06887036 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile