A Study to Evaluate Tobevibart + Elebsiran in Chronic HDV Infection

Last updated: September 23, 2025
Sponsor: Vir Biotechnology, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Liver Disease

Hepatitis

Liver Disorders

Treatment

Elebsiran

Tobevibart

Clinical Study ID

NCT06903338
VIR-CHDV-V203
  • Ages 18-70
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. Any clinically significant chronic or acute medical or psychiatric condition thatmakes 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, itsmetabolites, 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 apositive drug screen at screening unless it can be explained by a prescribedmedication

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Elebsiran
Phase: 3
Study Start date:
March 12, 2025
Estimated Completion Date:
May 31, 2031

Connect with a study center

  • Investigative Site

    Calgary, Alberta T2N 4Z6
    Canada

    Site Not Available

  • Investigative Site

    Calgary 5913490, Alberta 5883102 T2N 4Z6
    Canada

    Active - Recruiting

  • Investigative Site

    Montréal, Quebec H2L 4E9
    Canada

    Site Not Available

  • Investigative Site

    Montreal 6077243, Quebec 6115047 H2L 4E9
    Canada

    Active - Recruiting

  • Investigative Site

    Ottawa 6094817, K1H8L6
    Canada

    Active - Recruiting

  • Investigative Site

    Québec, G1V 4G2
    Canada

    Site Not Available

  • Investigative Site

    Québec 6325494, G1V 4G2
    Canada

    Active - Recruiting

  • Investigative Site

    Vancouver, V6Z 2C7
    Canada

    Site Not Available

  • Investigative Site

    Vancouver 6173331, V6Z 2C7
    Canada

    Active - Recruiting

  • Investigative Site

    Tbilisi, 0159
    Georgia

    Site Not Available

  • Investigative Site

    Tbilisi 611717, 0159
    Georgia

    Active - Recruiting

  • Investigative Site

    Frankfurt 2925536, 60590
    Germany

    Active - Recruiting

  • Investigative Site

    Hannover, 30625
    Germany

    Site Not Available

  • Investigative Site

    Hanover 2910831, 30625
    Germany

    Active - Recruiting

  • Investigative Site

    Heidelberg 2907911, 69120
    Germany

    Active - Recruiting

  • Investigative Site

    Chisinau 618426, 2025
    Moldova

    Active - Recruiting

  • Investigative Site

    Chisinau, 2025
    Moldova, Republic of

    Site Not Available

  • Investigative Site

    Auckland, 1010
    New Zealand

    Site Not Available

  • Investigative Site

    Auckland 2193733, 1010
    New Zealand

    Active - Recruiting

  • Investigative Site

    Karachi, 74800
    Pakistan

    Site Not Available

  • Investigative Site

    Karachi 1174872, 75600
    Pakistan

    Active - Recruiting

  • Investigative Site

    Lahore 1172451, 54800
    Pakistan

    Active - Recruiting

  • Investigative Site

    Rawalpindi 1166993, 46000
    Pakistan

    Active - Recruiting

  • Investigative Site

    Bucharest 683506, 030303
    Romania

    Active - Recruiting

  • Investigative Site

    Bucuresti, 030303
    Romania

    Site Not Available

  • Investigative Site

    Kyiv, 01135
    Ukraine

    Site Not Available

  • Investigative Site

    Kyiv 703448, 01135
    Ukraine

    Active - Recruiting

  • Investigative Site

    London, SE5 9RS
    United Kingdom

    Site Not Available

  • Investigative Site

    London 2643743, SE5 9RS
    United Kingdom

    Active - Recruiting

  • Investigative Site

    Manchester 2643123, M8 5RB
    United Kingdom

    Active - Recruiting

  • Investigative Site

    Nottingham 2641170, NG7 2UH
    United Kingdom

    Active - Recruiting

  • Investigative Site

    Chandler, Arizona 85224
    United States

    Site Not Available

  • Investigative Site

    Chandler 5289282, Arizona 5551752 85224
    United States

    Active - Recruiting

  • Investigative Site

    Redwood City, California 94063
    United States

    Site Not Available

  • Investigative Site

    San Francisco, California 94143
    United States

    Site Not Available

  • Investigative Site

    Los Angeles 5368361, California 5332921 90033
    United States

    Active - Recruiting

  • Investigative Site

    Redwood City 5386834, California 5332921 94063
    United States

    Active - Recruiting

  • Investigative Site

    San Francisco 5391959, California 5332921 94143
    United States

    Active - Recruiting

  • Investigative Site

    DeLand, Florida 32720
    United States

    Site Not Available

  • Investigative Site

    DeLand 4152890, Florida 4155751 32720
    United States

    Active - Recruiting

  • Investigative Site

    Chicago 4887398, Illinois 4896861 60612
    United States

    Active - Recruiting

  • Investigative Site

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Investigative Site

    Baltimore 4347778, Maryland 4361885 21287
    United States

    Active - Recruiting

  • Investigative Site

    Hillsborough, New Jersey 08844
    United States

    Site Not Available

  • Investigative Site

    Hillsborough 5099079, New Jersey 5101760 08844
    United States

    Active - Recruiting

  • Investigative Site

    New York, New York 10029
    United States

    Site Not Available

  • Investigative Site

    New York 5128581, New York 5128638 10016
    United States

    Active - Recruiting

  • Investigative Site

    Murray, Utah 84107
    United States

    Site Not Available

  • Investigative Site

    Murray 5778755, Utah 5549030 84107
    United States

    Active - Recruiting

  • Investigative Site

    Seattle, Washington 98105
    United States

    Site Not Available

  • Investigative Site

    Seattle 5809844, Washington 5815135 98105
    United States

    Active - Recruiting

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