Clinical Trial TitleA Phase 3, Randomized, Open-Label, Parallel Arm Study to Evaluate the Efficacy and Safety of 180 mcg Peginterferon Lambda-1a (Lambda) Subcutaneous Injection for 48 Weeks in Patients with Chronic Hepatitis Delta Virus (HDV) Infection (LIMT-2)
National Clinical Trial Number:NCT05070364
Clinical Trial Protocol Description:
This is a study investigating the use of Peginterferon Lambda-1a (Lambda), compared to placebo, in patients with Hepatitis D. Subjects must be on treatment for Hepatitis B and have an undetectable viral load. Study duration is 84-96 weeks and the active treatment phase is 48 weeks.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have chronic HDV infection documented by a positive HDV antibody test and a quantifiable HDV RNA (≥40 IU/mL).
- Have documented confirmed suppression of HBV DNA (< 100 IU/mL) following at least 12 weeks of anti-HBV NUC treatment with ETV or a TNF-based NUC (TDF or TAF).
- Have serum ALT > upper limit of normal (ULN) and < 10 × ULN.
You will be excluded from the study if any of the following criteria apply to you:
- Have total bilirubin (TBILI) > upper limit of normal (ULN).
- Have hemoglobin < 11 g/dL for women and < 12 g/dL for men.
- Have had treatment with interferons (IFNs) or immunomodulators within 6 months before Screening Visit 1 or refractory to prior IFN treatment.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.