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| Name | Class |
|---|---|
| NGM Biopharmaceuticals Australia Pty Ltd | INDUSTRY |
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The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Primary Biliary Cirrhosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NGM282 Dose 1 | Experimental | NGM282 Dose 1 |
|
| NGM282 Dose 2 | Experimental | NGM282 Dose 2 |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NGM282 | Biological |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change in plasma ALP from Baseline to Day 28 | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change in bilirubin from Baseline to Day 28 | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen J Rossi, PharmD | NGM Biopharmaceuticals, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NGM Clinical Study Site 103 | Phoenix | Arizona | United States | |||
| NGM Clinical Study Site 108 |
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| Label | URL |
|---|---|
| Related Info | View source |
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|
| Coronado |
| California |
| United States |
| NGM Clinical Study Site 101 | Detroit | Michigan | United States |
| NGM Clinical Study Site 105 | Durham | North Carolina | United States |
| NGM Clinical Study Site 102 | Dallas | Texas | United States |
| NGM Clinical Study Site 113 | San Antonio | Texas | United States |
| NGM Clinical Study Site 104 | Richmond | Virginia | United States |
| NGM Clinical Study Site 602 | Sydney | New South Wales | Australia |
| NGM Clinical Study Site 606 | Sydney | New South Wales | Australia |
| NGM Clinical Study Site 609 | Sydney | New South Wales | Australia |
| NGM Clinical Study Site 611 | Sydney | New South Wales | Australia |
| NGM Clinical Study Site 614 | Brisbane | Queensland | Australia |
| NGM Clinical Study Site 607 | Adelaide | South Australia | Australia |
| NGM Clinical Study Site 608 | Adelaide | South Australia | Australia |
| NGM Clinical Study Site 601 | Melbourne | Victoria | Australia |
| NGM Clinical Study Site 604 | Melbourne | Victoria | Australia |
| NGM Clinical Study Site 613 | Melbourne | Victoria | Australia |
| ID | Term |
|---|---|
| D008105 | Liver Cirrhosis, Biliary |
| ID | Term |
|---|---|
| D002780 | Cholestasis, Intrahepatic |
| D002779 | Cholestasis |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D008103 | Liver Cirrhosis |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000710649 | aldafermin |
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