Phase 2 LIMT HDV (Mono) Study

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 NCT02765802

Phase 2 LIFT (Combo) Study

LIFT (Lambda InterFeron combo-Therapy) is an open-label, Phase 2 study evaluating Lambda + LNF + RTV in approximately 26 HDV-infected patients. Patients will be dosed for 24 weeks + undergo follow up for 24 weeks. Primary endpoint will be ≧ 2 log decline in HDV RNA at end of treatment. Secondary endpoints will include histology (>2 point improvement in histological activity index and no progression in fibrosis) at end of treatment. LIFT will be conducted within the National Institutes of Health (NIH) at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and enrollment is planned for 2Q 2018.

See NCT02765802

Hepatitis Delta (HDV)

HDV Slide