NCT02765802

A Study to Evaluate Pegylated Interferon Lambda Monotherapy in Patients With Chronic Hepatitis Delta Virus Infection

A Phase 2 Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Pegylated Interferon Lambda Monotherapy in Patients With Chronic Hepatitis Delta Virus Infection (LIMT)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Eiger BioPharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To evaluate safety and tolerability of lambda over a 48-week treatment period in HDV patients.

Detailed description

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.

Conditions

• Hepatitis D, Chronic

Interventions

Type	Name	Description
DRUG	Peginterferon Lambda-1A

Timeline

• Start date: 2016-10-19
• Primary completion: 2018-07-20
• Completion: 2018-12-12
• First posted: 2016-05-09
• Last updated: 2023-01-17
• Results posted: 2023-01-17

Locations

4 sites across 3 countries: Israel, New Zealand, Pakistan

Regulatory

• FDA-regulated drug study