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

Last updated: August 6, 2024
Sponsor: Vir Biotechnology, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Hepatitis

Liver Disorders

Treatment

NRTI

VIR-3434

VIR-2218

Clinical Study ID

NCT05461170
VIR-CHDV-V201
  • Ages 18-69
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

  • Anti-HBs >10 mIU/mL at screening if only adding a select set of EC

  • Non-cirrhotic and CPT-A cirrhotic

Exclusion

Exclusion Criteria:

  • Any clinically significant chronic or acute medical or psychiatric condition thatmakes 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, itsmetabolites, 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 orchemotherapeutic agent, or chronic corticosteroids.

Study Design

Total Participants: 124
Treatment Group(s): 3
Primary Treatment: NRTI
Phase: 2
Study Start date:
September 17, 2022
Estimated Completion Date:
August 31, 2029

Study Description

Participants may be enrolled into Cohort 1 (1a and 1b) or Cohort 2 (2a, 2b1 or 2b2, 2c), 3, 4, and 5.

Connect with a study center

  • Investigative Site

    Sofia, 1407
    Bulgaria

    Active - Recruiting

  • Investigative Site

    Stara Zagora, 6003
    Bulgaria

    Active - Recruiting

  • Investigative Site

    Clichy, 92110
    France

    Active - Recruiting

  • Investigative Site

    Pessac, 33600
    France

    Active - Recruiting

  • Investigative Site

    Rennes, 35000
    France

    Active - Recruiting

  • Investigative Site

    Toulouse, 31000
    France

    Active - Recruiting

  • Investigative Site

    Frankfurt, 60596
    Germany

    Completed

  • Investigative Site

    Hannover, 30625
    Germany

    Active - Recruiting

  • Investigative Site

    Hanover, 30625
    Germany

    Site Not Available

  • Investigative Site

    Mainz, 55131
    Germany

    Site Not Available

  • Investigative Site

    Tübingen, 72076
    Germany

    Completed

  • Investigative Site

    Milano, 20122
    Italy

    Active - Recruiting

  • Investigative Site

    Piedimonte Matese, 10126
    Italy

    Site Not Available

  • Investigative Site

    Pisa, 56124
    Italy

    Active - Recruiting

  • Investigative Site

    Torino, 10126
    Italy

    Site Not Available

  • Investigative Site

    Chisinau, MD-2025
    Moldova, Republic of

    Active - Recruiting

  • Investigative Site

    Rotterdam, 3015 GD
    Netherlands

    Active - Recruiting

  • Investigative Site

    Auckland, 1010
    New Zealand

    Active - Recruiting

  • Investigative Site

    Bucharest, 021105
    Romania

    Active - Recruiting

  • Investigative Site

    Birmingham, B15 2TT
    United Kingdom

    Active - Recruiting

  • Investigative Site

    London, E1 1RF
    United Kingdom

    Active - Recruiting

  • Investigative Site

    Manchester, M8 5RB
    United Kingdom

    Active - Recruiting

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