Ignite Creation Date:
2025-12-25 @ 3:43 AM
Ignite Modification Date:
2026-04-06 @ 4:55 PM
Study NCT ID:
NCT02765802
Status:
COMPLETED
Last Update Posted:
2023-01-17
First Post:
2016-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate Pegylated Interferon Lambda Monotherapy in Patients With Chronic Hepatitis Delta Virus Infection
Sponsor:
Eiger BioPharmaceuticals
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LIMT
Brief 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.
* 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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: