Phase 2
N=33
A Study to Evaluate Pegylated Interferon Lambda Monotherapy in Patients With Chronic Hepatitis Delta Virus Infection
Hepatitis D, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT02765802 ↗Enrolled (actual)
33
Serious AEs
21.2%
Results posted
Jan 2023
Primary outcome: Primary: Change From Baseline in HDV Viral Load. — -2.14; -1.16 Change in HDV RNA log IU/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Peginterferon Lambda-1A (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eiger BioPharmaceuticals
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HDV Viral Load. |
-2.14; -1.16 | — |
| SECONDARY Change From Baseline in HDV Viral Load |
-1.70; -0.66 | — |
| SECONDARY Number of Patients With a Durable Virologic Response |
5; 3 | — |
Summary
To evaluate safety and tolerability of lambda over a 48-week treatment period in HDV patients.
Eligibility Criteria
Inclusion Criteria
- Chronic HDV infection of at least 6 months' duration documented by a positive HDV antibody (Ab) test, detectable and quantifiable HDV RNA by qPCR at study entry
- Serum alanine aminotransferase (ALT) > upper limit of the normal range (ULN) and 2 weeks) with agents that have a high risk for nephrotoxicity or hepatotoxicity unless it is approved by the medical monitor
- Receipt of systemic immunosuppressive therapy within 3 months before screening
Data sourced from ClinicalTrials.gov (NCT02765802). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.