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