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the enrollment was slow and never completed.
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The purpose of this study is to assess the optimal dose of EBP921 by comparing the efficacy and safety of 2 dose regimens in patients with chronic HDV.
This is an open-label, phase 1b, proof-of-concept study to assess the safety and efficacy of EBP921, a prenylation inhibitor, in subjects chronically infected with delta hepatitis. Subjects will be randomized to receive one of two different doses of EBP921. Dosing will occur over 28-days and during that time, evidence of antiviral response will be assessed by frequent measurements of HDV-RNA via PCR assay. In addition, safety lab data will also be collected along with surveillance monitoring of HBV activity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Low Dose for 28 days: n=4 |
|
| Group 2 | Experimental | High Dose for 28 days; n=4 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EBP921 | Drug | Patients randomized to receive low or high dose. All dosing of EBP921 should be taken with food. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HDV-RNA | The primary efficacy endpoint will be the median change in HDV-RNA from baseline to HDV RNA nadir as measured by quantitative PCR during the 28-day dosing period. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HDV RNA from baseline to Day 7, 14, 28 and post therapy weeks 1,2,4,8 | The median change in HDV RNA from baseline to Days 7, 14, 28, and post-therapy Weeks 1, 2, 4, and 8 of the study; the proportion of patients with alanine aminotransferase (ALT) normalization defined as ALT ≤ upper limit of normal for patients with ALT > ULN at baseline; assessment of peripheral blood mononuclear cell (PBMC) proliferation after 14 and 28 days exposure to EBP921; the percentage of patients with undetectable HDV RNA at Days 7, 14, 28, post-therapy Weeks 1, 2, 4, and 8; the median change in HBV DNA at Days 7, 14, 21, 28, 35, and 42, and HBsAg at Days 14, 28, and 42. |
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Inclusion Criteria:
Exclusion Criteria:
16. Patients with a history of multiple drug resistant HBV 17. Patients receiving interferon therapy for any reason.
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| Name | Affiliation | Role |
|---|---|---|
| Brian Murphy, MD, MPH | Eiger BioPharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco | California | United States | ||||
| Henry Ford Hospital |
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| ID | Term |
|---|---|
| D003699 | Hepatitis D |
| D006505 | Hepatitis |
| ID | Term |
|---|---|
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D012327 | RNA Virus Infections |
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| 8 Weeks |
| Detroit |
| Michigan |
| 48202 |
| United States |
| D008107 |
| Liver Diseases |
| D004066 | Digestive System Diseases |