A 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) Infectio

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

Individuals must meet all of the following inclusion criteria:
1.a) Chronic HDV infection documented by a positive HDV antibody test or a positive HDV RNA by RT-PCR test for at least 6 months prior to Screening
AND
b) Quantifiable HDV RNA by RT-PCR test at Screening
2.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) at Screening Visit 2.
3.Serum ALT > upper limit of normal (ULN) and < 10 × ULN.
4.Patients categorized with Child-Turcotte-Pugh score of =5 with well compensated liver disease.
5.Male or female, 18 to 70 years of age, inclusive.
6.Body mass index (BMI) of = 18.0 kg/m2 and < 40 kg/m2.
7.Electrocardiogram (ECG) demonstrating no acute ischemia or clinically significant abnormality and a corrected QT interval by Fridericia correction formula (QTcF) < 450 ms for male patients and < 460 ms for female patients.
8. Females of childbearing potential and males with partners of childbearing potential must agree to use adequate methods of contraception during the study and through 90 days after the last dose of study medication. Females of childbearing potential are all those except women who are surgically sterile, who have medically documented bilateral ovarian failure, or who are at least 1 year postmenopausal (12 consecutive months with no menstruation).
For females: 2 of the following contraceptive methods are required, with at least 1 being a barrier method:
·Hormonal contraceptives for 27 days before dosing
·Intrauterine device (IUD) in place 27 days before dosing
·Double-barrier methods (use of condom [male partner] with either diaphragm with spermicide or cervical cap with spermicide) from screening
·Surgical sterilization of the partner (vasectomy 1 month before screening)
For males, the following are considered acceptable options:
·Surgical sterilization (vasectomy 1 month before screening)
or
·Use of both of the following contraceptive methods from screening:
-Consistent and correct use of a male condom
-Partner must use a hormonal contraceptive or a nonhormonal barrier method (IUD or diaphragm with spermicide or cervical cap with spermicide).
9.Willing and able to comply with study procedures and provide written informed consent.
10.Able to read and understand a language in which an informed consent form and other patient study documents are available.
11.Able to self-administer medication orally and via subcutaneous (SC) injection (following training by site personnel).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 130
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Individuals meeting any of the following criteria will be excluded from the study:
1. Participation in a clinical trial with or use of any investigational agent within 30 days before Screening Visit 1.
2. Treatment with interferons (IFNs) or immunomodulators within 12 months before Screening Visit 1 or refractory to prior IFN treatment.
3. History or evidence of any hypersensitivity to IFNs or other substances contained in the study medication.
4. Female patients who are pregnant or breastfeeding. Female patients must have a negative serum pregnancy test at screening and a negative urine pregnancy test within 24 hours of start of IP.
5. Patients who are not eligible for treatment with either ETV or a TDF-based NUC based on prior demonstrated treatment intolerance and/or failure

For a more detailed list of Exclusions Based on Disease and Exclusions Based on Concurrent Medication Use please refer to Sections 4.2.2 and 4.3.2 of the protocol.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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