To evaluate safety and tolerability of lambda over a 48-week treatment period in HDV patients.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Soroka Medical Center
Beersheba, Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Auckland City Hospital
Grafton, Auckland, New Zealand
The Aga Khan University and Hospital
Karachi, Pakistan
Change From Baseline in HDV Viral Load.
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 hepatitis D virus (HDV) ribonucleic acid (RNA) levels.
Time frame: Week 48 (end of treatment)
Change From Baseline in HDV Viral Load
To evaluate the proportion of patients with undetectable HDV RNA 24 weeks after the end of treatment
Time frame: Week 72 (end of follow-up)
Number of Patients With a Durable Virologic Response
Durable Virologic Response (DVR) = below the limit of quantitation in HDV RNA at 24 weeks post-treatment
Time frame: Week 72
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.