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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05461170
Recruitment Status : Recruiting
First Posted : July 18, 2022
Last Update Posted : February 9, 2023
Sponsor:
Information provided by (Responsible Party):
Vir Biotechnology, Inc.

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Hepatitis D, Chronic Drug: VIR-2218 Drug: VIR-3434 Phase 2

Detailed Description:
Participants may be enrolled into Cohort 1 (1a and 1b) or Cohort 2 (2a, 2b1 or 2b2, 2c) using non-randomized (Cohort 1) and randomized (Cohort 2) manners
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study to Evaluate Efficacy, Safety and Tolerability of VIR-2218 and VIR-3434 in Participants With Chronic Hepatitis D Virus Infection (SOLSTICE)
Actual Study Start Date : September 17, 2022
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1a (VIR-2218)
Participants will receive multiple doses of VIR-2218 for up to 88 weeks total
 Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Experimental: Cohort 1b (VIR-3434)
Participants will receive multiple doses of VIR-3434 for up to 88 weeks total.
 Drug: VIR-3434
VIR-3434 given by subcutaneous injection
Experimental: Cohort 2a (VIR-2218)
Participants will receive multiple doses of VIR-2218 for 92 weeks.
 Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Experimental: Cohort 2b1 (VIR-3434)
Participants will receive multiple doses of VIR-3434 for 24 or 48 weeks followed by VIR-3434 or VIR-3434 + VIR-2218 for an additional 44 or 68 weeks.
 Drug: VIR-3434
VIR-3434 given by subcutaneous injection
Experimental: Cohort 2b2 (VIR-3434)
Participants will receive multiple doses of VIR-3434 for 48 weeks followed by VIR-3434 or VIR-3434 + VIR-2218 for an additional 44 weeks.
 Drug: VIR-3434
VIR-3434 given by subcutaneous injection
Experimental: Cohort 2c (VIR-2218 + VIR-3434)
Participants will receive multiple doses of VIR-2218 + VIR-3434 for 92 weeks total
 Drug: VIR-2218
VIR-2218 given by subcutaneous injection

Drug: VIR-3434
VIR-3434 given by subcutaneous injection


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of participants with ≥ 2log10 decrease in HDV RNA from baseline or HDV RNA < Lower Limit of Quantitation (LLOQ; target not detected [TND]) and ALT normalization (<upper limit of normal [ULN]) at Week 24 (Cohort 2 only). [ Time Frame: Up to 24 Weeks ]
  2. Proportion of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) [ Time Frame: Up to 102 Weeks ]

Secondary Outcome Measures :
  1. Proportion of participants with ≥ 2log10 decrease in HDV RNA from baseline or HDV RNA < LLOQ (target detected (TD) or TND) and ALT normalization (<ULN) at Week 12, 48, 72 and 96. [ Time Frame: Up to 96 Weeks ]
  2. Proportion of participants with ≥ 2 log10 decrease in HDV RNA from baseline or plasma HDV RNA <LLOQ (TD or TND) at Week 12, 24, 48, 72 and 96. [ Time Frame: Up to 96 Weeks ]
  3. Change from baseline in HDV RNA at Week 12, 24, 48, 72, and 96. [ Time Frame: Up to 96 Weeks ]
  4. Incidence of anti-drug antibodies to VIR-3434 [ Time Frame: Up to 96 Weeks ]
  5. Titers of anti-drug antibodies to VIR-3434 [ Time Frame: Up to 96 Weeks ]
  6. Change from Baseline to Liver Fibrosis [ Time Frame: Up to 96 Weeks ]
    Liver Fibrosis will be measured by conventional Transient Elastography imaging technique reported in kPa.

  7. Change in Model for End Stage Liver Disease (MELD) Score from baseline [ Time Frame: Up to 96 Weeks ]
    MELD score will be calculated using serum bilirubin, serum creatinine, and International Normalized Ratio.

  8. Change from baseline Child-Pugh-Turcotte (CPT) Class [ Time Frame: Up to 96 Weeks. ]
  9. Proportion of participants with ALT normalization (<ULN) at Week 12, 24, 48, 72 and 96 [ Time Frame: Up to 96 Weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female ages 18 -< 70 years
  • Chronic HDV infection for >/= 6 months
  • On NRTI therapy for >/= 2 months at the time of screening

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05461170


Contacts
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Contact: Study Inquiry 415-654-5281 clinicaltrials@vir.bio

Locations
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Bulgaria
Investigative Site Not yet recruiting
Sofia, Bulgaria, 1407
Investigative Site Not yet recruiting
Sofia, Bulgaria, 1431
Investigative Site Not yet recruiting
Stara Zagora, Bulgaria, 6003
France
Investigative Site Not yet recruiting
Clichy, France, 92110
Investigative Site Not yet recruiting
Pessac, France, 33600
Investigative Site Not yet recruiting
Rennes, France, 35000
Investigative Site Not yet recruiting
Toulouse, France, 31400
Germany
Investigative Site Not yet recruiting
Frankfurt, Germany, 60431
Investigative Site Not yet recruiting
Hanover, Germany, 30625
Investigative Site Not yet recruiting
Mainz, Germany, 55131
Investigative Site Not yet recruiting
Tübingen, Germany, 72076
Italy
Investigative Site Not yet recruiting
Milano, Italy, 20122
Investigative Site Not yet recruiting
Pisa, Italy, 56124
Investigative Site Not yet recruiting
Torino, Italy, 10126
Moldova, Republic of
Investigative Site Recruiting
Chisinau, Moldova, Republic of, MD-2025
Netherlands
Investigative Site Not yet recruiting
Rotterdam, Netherlands, 3015
New Zealand
Investigative Site Recruiting
Auckland, New Zealand, 1010
Romania
Investigative Site Recruiting
Bucharest, Romania, 021105
United Kingdom
Investigative Site Recruiting
Birmingham, United Kingdom, B15 2TT
Investigative Site Recruiting
London, United Kingdom, E1 1RF
Investigative Site Recruiting
London, United Kingdom, SE5 9RS
Investigative Site Not yet recruiting
Manchester, United Kingdom, M8 5RB
Sponsors and Collaborators
Vir Biotechnology, Inc.
More Information
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Responsible Party: Vir Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT05461170    
Other Study ID Numbers: VIR-CHDV-V201
First Posted: July 18, 2022    Key Record Dates
Last Update Posted: February 9, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Vir Biotechnology, Inc.:
HDV
Hepatitis D Virus
Hepatitis
Chronic Hepatitis D Virus
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis D
Hepatitis D, Chronic
Hepatitis
Hepatitis, Chronic
Hepatitis, Viral, Human
Infections
 Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections