Methylene Blue in Patients with Chronic Hepatitis B Infection

Switzerland (ICTRP)

Identifiant de l'essai ICTRP
NCT06887036 (ICTRP)

Titre officiel (approuvé par le comité d'éthique)
Methylene Blue treatment of chronic Hepatitis B Virus infection: a pilot study (BASEC)

Titre académique
Methylene Blue Treatment of Chronic Hepatitis B Virus Infection: a Pilot Study (ICTRP)

Titre public
Methylene Blue Treatment of Chronic Hepatitis B Virus Infection (ICTRP)

Maladie en cours d'investigation
Chronic HBV Infection (ICTRP)

Intervention étudiée
Drug: Methylene Blue (ICTRP)

Type d'essai
Interventional (ICTRP)

Plan de l'étude
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)

Critères d'inclusion/exclusion
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 disponible

Critères d'évaluation principaux et secondaires
Reduction >1 log10 in the starting HBsAg level and > 2 log10 in the starting HBV DNA PCR level (ICTRP)

Adverse Events;Treatment adherence (ICTRP)

Date d'enregistrement
non disponible

Inclusion du premier participant
non disponible

Sponsors secondaires
non disponible

Contacts supplémentaires
Andreas CernyAndreas Cerny, andreas.cerny@hin.chandreas.cerny@hin.ch, 0041 91 910 65700041 91 910 6570 (ICTRP)

ID secondaires
Methylene Blue in chronic HBV (ICTRP)

Résultats-Données individuelles des participants
non disponible

Informations complémentaires sur l'essai
https://clinicaltrials.gov/study/NCT06887036 (ICTRP)