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Terminated early due to futility
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This is a proof of concept study, designed to look at the safety and antiviral activity of LCQ908 in hepatitis C infected patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LCQ908 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LCQ908 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Measure: Change in hepatitis C viral load as assessed by PCR | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Measure: Safety assessments will include vital signs, electrocardiograms (ECG), liver function tests, and adverse events. | 28 days | |
| Measure: LCQ908 concentrations in the blood | over 21 days |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Auckland | New Zealand | ||||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27788579 | Derived | Gane E, Stedman C, Dole K, Chen J, Meyers CD, Wiedmann B, Zhang J, Raman P, Colvin RA. A Diacylglycerol Transferase 1 Inhibitor Is a Potent Hepatitis C Antiviral in Vitro but Not in Patients in a Randomized Clinical Trial. ACS Infect Dis. 2017 Feb 10;3(2):144-151. doi: 10.1021/acsinfecdis.6b00138. Epub 2016 Nov 8. |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C000594809 | pradigastat |
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|
| Christchurch |
| New Zealand |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |