Clinical trial NCT06903338: A Study to Evaluate Tobevibart + Elebsiran in Chronic HDV Infection
Official title: A Phase 3 Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Tobevibart + Elebsiran Combination Therapy in Participants With Chronic HDV Infection (ECLIPSE 1)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Viral Hepatitis
Keywords: HDV
Hepatitis D Virus
Hepatitis
Chronic Hepatitis D Virus
Hepatitis D
Hepatitis D, Chronic
Hepatitis Delta Virus
Lead sponsor: Vir Biotechnology, Inc.
Sponsor class: INDUSTRY
First posted: 2025-03-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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 Criteria:

1. Any clinically significant chronic or acute medical or psychiatric condition that makes 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, its metabolites, 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 a positive drug screen at screening unless it can be explained by a prescribed medication

Primary outcomes:
measure: HDV RNA < Lower Limit of Quantification (LLOQ), Target Not Detected (TND) and alanine aminotransferase (ALT) normalization (ALT </= Upper Limit of Normal [ULN]) at Week 48 for Arm 1 vs at Week 12 for Arm 2
timeFrame: Up to 48 weeks
measure: Incidence of Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Week 12
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: HDV RNA < LLOQ, TND at Week 48 for Arm 1 vs Week 12 for Arm 2
timeFrame: Up to 48 weeks
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Investigative Site
state: Arizona
city: DeLand
country: United States
facility: Investigative Site
state: Florida
city: Hillsborough
country: United States
facility: Investigative Site
state: New Jersey
city: Seattle
country: United States
facility: Investigative Site
state: Washington
city: Montréal
country: Canada
facility: Investigative Site
state: Quebec
city: Chisinau
country: Moldova, Republic of
facility: Investigative Site
city: Bucuresti
country: Romania
facility: Investigative Site
city: Bucuresti
country: Romania
facility: Investigative Site
city: Kyiv
country: Ukraine
facility: Investigative Site
Study officials:
References: