A Study to Evaluate Pegylated Interferon Lambda Monotherapy in Patients With Chronic Hepatitis Delta Virus Infection
Status:
Completed
Trial end date:
2018-12-12
Target enrollment:
Participant gender:
Summary
Lambda is the pegylated form of interferon lambda-1a (IFN-λ), a conjugate of recombinant
human interleukin 29 (rIL-29) and a linear polyethylene glycol (PEG) chain. IFN-λ and
interferon alpha (IFN-α) share the common interferon (IFN)-stimulated gene induction pathway
that leads to broad-spectrum antiviral activities. Since IFN-α has demonstrated
anti-hepatitis delta virus (HDV) activity in patients with chronic hepatitis delta (CHD), it
is postulated that pegylated IFN-λ could also induce HDV ribonucleic acid (RNA) decline in
patients with CHD. Based on IFN-λ's more limited receptor distribution and previous data from
studies involving treatment with IFN-λ in patients with hepatitis B virus (HBV) or hepatitis
C virus (HCV), it is postulated that Lambda treatment could be associated with fewer adverse
effects than IFN-α treatment. This Phase II study is designed as randomized, open-label study
of Lambda 120 or 180 μg subcutaneous (SC) injection weekly for 48 weeks in patients with
chronic HDV infection, and the primary objectives of the study are as follows:
- To evaluate the safety and tolerability of treatment with 2 dose levels of Lambda over a
48-week treatment period.
- To evaluate the effect of treatment with 2 different doses of Lambda on HDV RNA levels.