Идёт набор NCT06887036

Methylene Blue Treatment of Chronic Hepatitis B Virus Infection

Фаза II С лечением Chronic HBV Infection

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Methylene Blue.
Кому может быть актуально: Состояния в реестре: Chronic HBV Infection. Базовые параметры: 18 лет — 79 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Швейцария
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Methylene Blue Treatment of Chronic Hepatitis B Virus Infection: a Pilot Study

Обзор

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. Diagnosis and treatment depend on the stage of infection, the degree of liver inflammation, and the progression of fibrosis. Patients with HBeAg-positive or -negative hepatitis are usually treated with nucleos(-t)ide analogues. This treatment inhibits HBV reverse transcriptase and reduces viral replication, but does not affect HBsAg production. Treatment must be continued for life in most cases and is associated with high cumulative costs and the risk of development of resistance. Recently, it has been shown that patients who show a decrease in their HBsAg levels are more likely to become HBsAg negative, seroconvert and be able to stop antiviral treatment, which is the ultimate goal of treatment, but unfortunately rarely achieved. Methylene blue (MB) has been shown to have an effect on HBsAg levels in vitro, making it a promising test for a new treatment for HBV. This is an explorative pilot study, open label, dose-escalation, single center clinical trial on the efficacy of MB against HBV infection. Primary objective is to assess the efficacy of incremental doses of MB against hepatitis B virus in patients with chronic hepatitis B assessed by the reduction of both the HBsAg and HBV DNA levels after 6 months of treatment and 6 months of follow-up. Participant will be treated for 6 months with MB 100 mg capsules, and then followed up for a further 6 months. The initial dose of MB might be increased if the patient is a non-responder.

Вмешательства

Препарат Methylene Blue
Subjects will be initially treated with an initial dose of 200mg/day for 8 weeks at which point the investigators will assess the effect of the treatment. Those patients that obtain a "complete response" will continue their treatment up to a total of 24 weeks with the same dose. Those who do not reach a "complete response" will be exposed to the next higher dose of 400mg/day for the following 8 weeks and the investigators will then again assess the effect of the treatment. Those patients that

Первичные конечные точки

Reduction >1 log10 in the starting HBsAg level and > 2 log10 in the starting HBV DNA PCR level [Срок оценки: From enrollment to the end of treatment at 6 months]

Вторичные конечные точки (2)

Adverse Events [Срок оценки: From enrollment to the end of follow up period (12 months in total)]
Treatment adherence [Срок оценки: From enrollment to the end of follow up period (12 months in total)]

Критерии участия

Критерии включения

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