Language: BG BG
← Back to results
Active (not recruiting) Phase 2 NCT05461170

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

Phase 2 – studying effectiveness and dosage
Conditions: Hepatitis D, Chronic

Sponsor: Vir Biotechnology, Inc.

trial.available_in: БГ
Overview
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
Description
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).
Who can participate
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
Locations 9
Bulgaria (1)
Investigative Site
Sofia
France (1)
Investigative Site
Clichy
Germany (1)
Investigative Site
Frankfurt
Italy (1)
Investigative Site
Milan
Moldova (1)
Investigative Site
Chisinau
Netherlands (1)
Investigative Site
Rotterdam
New Zealand (1)
Investigative Site
Auckland
Romania (1)
Investigative Site
Bucharest
United Kingdom (1)
Investigative Site
Birmingham
Technical details
Status
Active (not recruiting)
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
69 Years
Healthy volunteers
No
Start date
17.09.2022
Completion date
01.08.2029
Registry ID
NCT05461170
Source
anzctr
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.