A Study to Evaluate Pegylated Interferon Lambda Monotherapy in Patients With Chronic Hepatitis Delta Virus Infection (LIMT)
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|ClinicalTrials.gov Identifier: NCT02765802|
Recruitment Status : Active, not recruiting
First Posted : May 9, 2016
Last Update Posted : July 30, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis D, Chronic||Drug: Lambda||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||October 19, 2016|
|Actual Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Lambda 180 μg
Lambda 180 μg once weekly, administered by subcutaneous (SC) injection, for a total of 48 weeks.
Experimental: Lambda 120 μg
Lambda 120 μg once weekly, administered by subcutaneous (SC) injection, for a total of 48 weeks.
- Change from baseline in HDV viral load. [ Time Frame: Week 48 (end of treatment) ]
- Change from baseline in HDV viral load [ Time Frame: Week 72 (end of follow-up) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02765802
|Soroka Medical Center|
|Beersheba, Israel, 84101|
|Shaare Zedek Medical Center|
|Jerusalem, Israel, 9103102|
|Auckland City Hospital|
|Grafton, Auckland, New Zealand, 1142|
|The Aga Khan University and Hospital|
|Karachi, Pakistan, 74800|
|Study Director:||David Apelian, MD, PhD, MBA||Eiger BioPharmaceuticals|