Chronic Hepatitis Delta Virus (HDV) Infection MedDRA version: 20.1 Level: PT Classification code 10019762 Term: Hepatitis D System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Pegylated Interferon Lambda-1a
Product Code: 361529
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Peginterferon lambda-1A
CAS Number: 914617-98-4
Sponsors
Eiger BioPharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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 detectable HDV RNA (=?5 IU/mL) by RT-PCR test for at least 3 months prior to Screening Visit 1 AND b) Quantifiable HDV RNA (=?40 IU/mL) by RT-PCR test at Screening Visit 2 2. Documented confirmed suppression of HBV DNA ( 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 ? Intrauterine hormone-releasing system (IUS), in place 27 days prior to dosing ? Double-barrier methods (use of condom [male partner] with either diaphragm or cervical cap, in each case plus spermicide) from screening ? Surgical sterilization of the partner (vasectomy 1 month before screening) ? Sexual abstinence 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 with or without spermicide ? 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). 12. Dilated retinal examination at Screening Visit 2, performed by an ophthalmologist or other ocular specialist. ? For patients evidencing retinal abnormalities at screening, the investigator should review the findings with the ophthalmologist and the medical monitor to determine if the patient may be enrolled in the study. ? Patients with other, ocular findings may be enrolled, but should be monitored closely during the study, with a detailed ocular review of symptoms performed at each visit, and should undergo periodic repeat ophthalmologic examinations during treatment, at a frequency recommended by the treating ophthalmologist. 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 thi
Exclusion criteria
Exclusion criteria: Individuals meeting any of the following criteria will be excluded from the study: 1. Participation in a clinical trial with use of any investigational agent within 30 days before Screening Visit 1. 2. Treatment with interferons (IFNs) or immunomodulators within 6 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 TNF-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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the proportion of patients with HDV RNA < LLOQ (target detected [TD] or target not detected [TND]) at 24 weeks post-treatment (Week 72) following 48 weeks of treatment in Arm 1 to the proportion of patients with no treatment achieving HDV RNA level < LLOQ (TD or TND) at Week 12 in Arm 2.;Secondary Objective: 1.To compare the proportion of patients with HDV RNA < LLOQ1 (TND) at EOT (Week 48) and throughout 24 weeks post-treatment (Week 72) following 48 weeks of treatment in Arm 1 to the proportion of patients with no treatment achieving HDV RNA level < LLOQ (TD or TND) at Week 12 in Arm 2. 2.To compare the composite virologic and biochemical response rate at 24 weeks post-treatment (Week 72) in Arm 1 and at Week 12 in Arm 2. Composite virologic and biochemical response is defined by both of the following bullets: o = 2 log10 reduction in HDV RNA relative to baseline or HDV RNA < LLOQ (TD or TND); and o ALT normalization ;Primary end point(s): · The primary endpoint is the proportion of patients with HDV RNA < LLOQ (TD or TND), defined as follows for each treatment arm: o Lambda arm (Arm 1): the proportion of patients with HDV RNA < LLOQ (TD or TND) at 24 weeks post-treatment (Week 72) following 48 weeks of treatment o No treatment arm (Arm 2): the proportion of patients with HDV RNA < LLOQ (TD or TND) at Week 12 Note: All efficacy analyses will be performed in patients who have received at least 1 dose of study drug. ;Timepoint(s) of evaluation of this end point: HDV RNA < LLOQ (TD or TND) at 24 weeks Post-TRx (Arm1) versus 12 weeks Post-No TRx (Arm 2) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The proportion of patients with HDV RNA < LLOQ, defined as follows for each treatment arm: o Lambda arm (Arm 1): the proportion of patients with HDV RNA < LLOQ (TND) at EOT (Week 48) and throughout 24 weeks post-treatment (Week 72) o No treatment arm (Arm 2): the proportion of patients with HDV RNA < LLOQ (TND) at Week 12. 2. Composite virologic and biochemical response rate, defined as follows for each treatment arm: o Lambda arm (Arm 1): the proportion of patients with both (a) = 2 log10 reduction in HDV RNA relative to baseline or HDV RNA < LLOQ (TD or TND)]; and (b) ALT normalization at 24 weeks post-treatment (Week 72) o No-treatment arm (Arm 2): the proportion of patients with both (a) = 2 log10 reduction in HDV RNA relative to baseline or HDV RNA < LLOQ (TD or TND)]; and (b) ALT normalization at Week 12. ;Timepoint(s) of evaluation of this end point: 1. The proportion of patients with HDV RNA< LLOQ, defined as follows for each treatment arm: o Lambda arm(Arm 1): the proportion of patients with HDV RNA<LLOQ(TND) at EOT(Week 48) and throughout 24 weeks posttreatment(Week 72) o No treatment arm(Arm 2): the proportion of patients with HDV RNA<LLOQ(TND) at Week12. 2.Composite virologic and biochemical response rate, defined as follows for each treatment arm:o Lambda arm(Arm 1): the proportion of patients with both(a) = 2 log10 reduction in HDV RNA relative to baseline or HDV RNA<LLOQ(TD or TND)]; and(b)ALT normalization at 24 weeks posttreatment(Week 72) o No-treatment arm(Arm 2):the proportion of patients with both(a)=2log10 reduction in HDV RNA relative to baseline or HDV RNA< LLOQ(TD or TND)];and (b)ALT normalization at Week 12. | — |
Countries
Belgium, Bulgaria, France, Germany, Israel, Italy, Moldova, Republic of, Romania, Russian Federation, Spain, Turkey, Ukraine, United States
Contacts
Public ContactAlexander Romanov
Biorasi LLC
Outcome results
None listed