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Активно (без набиране) Фаза 2 NCT05461170

SOLSTICE: Combination Therapy for the Treatment of Chronic Hepatitis D Infection.

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Hepatitis D, Chronic

Спонсор: Vir Biotechnology, Inc.

Налично на: БГ
Обобщение
This is a phase 2 trial in which participants with chronic hepatitis D virus (HDV) infection will receive VIR-2218 and/or VIR-3434 and be assessed for safety, tolerability, and efficacy
Описание
Participants may be enrolled into Cohort 1 (1a and 1b) or Cohort 2 (2a, 2b1 or 2b2, 2c), 3, 4, and 5. All participants still receiving VIR-2218 or VIR-3434 monotherapy at the time of implementation of Protocol Amendment 4 will switch to combination therapy at Week 132 (Cohort 2a, 2b1/2b2) or Week 112 (Cohort 3).
Кой може да участва
Inclusion Criteria: * Male or female ages 18 to \< 70 years at screening * Chronic HDV infection for \>/= 6 months * On NRTI therapy for at least 12 weeks prior to day 1 * ALT\>ULN and \< 5x ULN * Non-cirrhotic and CPT-A cirrhotic Exclusion Criteria: * Any clinically significant chronic or acute medical or psychiatric condition that makes the participant unsuitable for participation. * History of significant liver disease from non-HBV or non-HDV etiology * History of allergic reactions, hypersensitivity, or intolerance to study drug, its metabolites, or excipients. * History of anaphylaxis * History of immune complex disease * History of autoimmune disorder * History or evidence of alcohol or drug abuse * Prior or concomitant therapy with an immunomodulatory agent, IFN-alpha, cytotoxic or chemotherapeutic agent, or chronic corticosteroids. * Anti-HBs \>10 mIU/mL at screening
Места на провеждане 9
България (1)
Investigative Site
Sofia
Франция (1)
Investigative Site
Clichy
Германия (1)
Investigative Site
Frankfurt
Италия (1)
Investigative Site
Milan
Moldova (1)
Investigative Site
Chisinau
Нидерландия (1)
Investigative Site
Rotterdam
New Zealand (1)
Investigative Site
Auckland
Румъния (1)
Investigative Site
Bucharest
Великобритания (1)
Investigative Site
Birmingham
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
69 Years
Здрави доброволци
Не
Начална дата
17.09.2022
Крайна дата
01.08.2029
Регистрационен номер
NCT05461170
Източник
anzctr
Запитване за медицински туризъм

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