Combination therapy for chronic hepatitis D infection
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)
PHASE2 · Vir Biotechnology, Inc. · NCT05461170
This study is testing a new combination of treatments for people with chronic hepatitis D to see if it can help manage their infection better.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 18 Years to 69 Years |
| Sex | All |
| Sponsor | Vir Biotechnology, Inc. (industry) |
| Locations | 20 sites (Sofia and 19 other locations) |
| Trial ID | NCT05461170 on ClinicalTrials.gov |
What this trial studies
This phase 2 trial evaluates the safety, tolerability, and efficacy of VIR-2218 and/or VIR-3434 in participants with chronic hepatitis D virus (HDV) infection. Participants will be assigned to different cohorts based on specific inclusion criteria, including their liver health and prior treatments. The study aims to determine the effectiveness of these combination therapies in managing chronic HDV infection.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with chronic HDV infection who have been on NRTI therapy for at least 12 weeks.
Not a fit: Patients with significant liver disease from non-HBV or non-HDV causes or those with a history of severe allergic reactions to the study drugs may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients suffering from chronic hepatitis D infection.
How similar studies have performed: Other studies have shown promise with similar combination therapies for hepatitis infections, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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.
Where this trial is running
Sofia and 19 other locations
- Investigative Site — Sofia, Bulgaria (RECRUITING)
- Investigative Site — Sofia, Bulgaria (RECRUITING)
- Investigative Site — Stara Zagora, Bulgaria (RECRUITING)
- Investigative Site — Clichy, France (RECRUITING)
- Investigative Site — Pessac, France (RECRUITING)
- Investigative Site — Rennes, France (RECRUITING)
- Investigative Site — Toulouse, France (RECRUITING)
- Investigative Site — Frankfurt, Germany (COMPLETED)
- Investigative Site — Hannover, Germany (RECRUITING)
- Investigative Site — Tübingen, Germany (COMPLETED)
- Investigative Site — Milano, Italy (RECRUITING)
- Investigative Site — Pisa, Italy (RECRUITING)
- Investigative Site — Chisinau, Moldova, Republic of (RECRUITING)
- Investigative Site — Rotterdam, Netherlands (RECRUITING)
- Investigative Site — Auckland, New Zealand (RECRUITING)
- Investigative Site — Bucharest, Romania (RECRUITING)
- Investigative Site — Birmingham, United Kingdom (RECRUITING)
- Investigative Site — London, United Kingdom (RECRUITING)
- Investigative Site — London, United Kingdom (RECRUITING)
- Investigative Site — Manchester, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Study Inquiry
- Email: clinicaltrials@vir.bio
- Phone: 415-654-5281
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hepatitis D, Chronic, HDV, Hepatitis D Virus, Hepatitis, Chronic Hepatitis D Virus