LIMT HDV is a 1:1 randomized, open-label study of Lambda 120 or 180 microgram subcutaneous injections administered weekly for 48 weeks in 33 patients with chronic HDV. End of treatment will be followed by a treatment-free 24-week observation period. The primary objective of the phase 2 study is to evaluate the safety, tolerability, and efficacy of treatment with two dose levels of Lambda monotherapy in patients with chronic HDV infection. All patients will also be administered an anti-hepatitis B virus nucleos(t)ide analog throughout the study. LIMT HDV is an international study being conducted at sites in New Zealand, Israel and Pakistan.
See clinicaltrials.gov: NCT02765802