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Sponsor has discontinued the development of emricasan
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A post-treatment follow-up observational study for liver disease subjects with or without liver cirrhosis after receiving emricasan or placebo.
Subjects must have been enrolled in a prior IDN-6556 study to be eligible.
A multi-center, post-treatment follow-up observational study for liver disease subjects with or without liver cirrhosis after receiving emricasan or placebo.
This phase 2 observational study will enroll subjects from Study IDN-6556-07 (Post Orthotropic Liver Transplantation - NCT02138253), IDN-6556-12 (NASH Fibrosis - NCT02686762), IDN-6556-14 (NASH Cirrhosis and Severe Portal Hypertension - NCT02960204) or IDN-6556-17 (Decompensated NASH Cirrhosis - NCT03205345) who have received at least one dose of emricasan or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Historical emricasan or placebo subjects | Subjects with liver fibrosis or cirrhosis who have received at least one dose of emricasan or placebo in a prior IDN-6556 study including IDN-6556-07, IDN-6556-12, IDN-6556-14 or IDN-6556-17. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound | Diagnostic Test | Subjects will be observed to estimate the adjusted event rate for hepatocellular carcinoma with or without cirrhosis previously treated with emricasan or placebo. |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted event rate for hepatocellular carcinoma. | To estimate the adjusted event rate for hepatocellular carcinoma in subjects with or without cirrhosis previously treated with emricasan or placebo. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted event rate for all malignancies. | To estimate the adjusted event rate for all malignancies in subjects with or without cirrhosis previously treated with emricasan or placebo. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who previously received at least one dose of emricasan or placebo in clinical study IDN-6556-07 (post orthotopic liver transplant due to HCV), IDN-6556-12 (NASH fibrosis), IDN-6556-14 (NASH cirrhosis), and IDN-6556-17 (NASH cirrhosis).
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| Name | Affiliation | Role |
|---|---|---|
| Mason Yamashita, MD | Conatus Pharmaceuticals Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inland Empire Liver Foundation | Rialto | California | 92377 | United States | ||
| Options Health Research, LLC |
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|
| Tulsa |
| Oklahoma |
| 74104 |
| United States |
| Gastro One | Germantown | Tennessee | 38138 | United States |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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