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Активно (без набиране) Фаза 3 NCT06903338

A Study to Evaluate Tobevibart + Elebsiran in Chronic HDV Infection

Фаза 3 – широко изпитване преди одобрение
Заболявания: Viral Hepatitis

Спонсор: Vir Biotechnology, Inc.

Налично на: БГ
Обобщение
This is a multicenter, open label, randomized Phase 3 clinical study to evaluate the efficacy and safety of the combination of tobevibart + elebsiran for the treatment of chronic hepatitis delta in comparison to delayed treatment.
Кой може да участва
Inclusion Criteria: 1. Male or female ages 18 to 70 years at screening 2. Chronic HDV infection for \>/= 6 months 3. On NRTI therapy against HBV for at least 12 weeks prior to day 1 or have HBV DNA \< 20 IU/ml at screening, currently on locally approved NRTI therapy 4. Serum ALT \> ULN and \< 5x ULN 5. Non-cirrhotic or Compensated Cirrhotic Liver Disease at screening Exclusion Criteria: 1. Any clinically significant chronic or acute medical or psychiatric condition that makes the participant unsuitable for participation. 2. History of significant liver disease from non-HBV or non-HDV etiology 3. History of allergic reactions, hypersensitivity, or intolerance to study drug, its metabolites, or excipients. 4. History of anaphylaxis 5. History of immune complex disease 6. History of autoimmune disorder 7. History or evidence of alcohol or drug abuse within 6 months before screening or a positive drug screen at screening unless it can be explained by a prescribed medication
Места на провеждане 10
Канада (1)
Investigative Site
Calgary , Alberta
Georgia (1)
Investigative Site
Tbilisi
Германия (1)
Investigative Site
Frankfurt
Moldova (1)
Investigative Site
Chisinau
New Zealand (1)
Investigative Site
Auckland
Pakistan (1)
Investigative Site
Karachi
Румъния (1)
Investigative Site
Bucharest
Ukraine (1)
Investigative Site
Kyiv
Великобритания (1)
Investigative Site
London
САЩ (1)
Investigative Site
Chandler , Arizona
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
70 Years
Здрави доброволци
Не
Начална дата
12.03.2025
Крайна дата
01.05.2031
Регистрационен номер
NCT06903338
Източник
anzctr
Запитване за медицински туризъм

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