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
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 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 ( upper limit of normal (ULN) and =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
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.
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 ContactStephanie James
Biorasi LLC
Outcome results
None listed