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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT number: 2009-009995-11 |
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This is a study designed to identify a dose of NIM811 that has a good safety profile, is well tolerated when co-administered with SOC, and provides a clinically meaningful effect in viral load reduction compared to SOC alone. This information will be used to support doses selected for future studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NIM811 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIM811 | Drug | BID in various doses (between 100 mg - 600 mg bid) + SOC (PEG IFN and RBV) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of NIM811 dosed daily for 4 weeks in combination with SOC | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To identify a dose of NIM811 which is safe and tolerated and produces in combination with SOC a clinically meaningful improvement over SOC monotherapy in antiviral response Time Frame: 4 weeks | 12 weeks | |
| To assess the percentage of patients achieving rapid virologic response (RVR) in patients treated with NIM811 in combination with SOC |
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Inclusion criteria:
Patients eligible for inclusion in this study have to fulfill all of the following criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research and Education Inc. | San Diego | California | 92105 | United States | ||
| Orlando Clinical Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21255610 | Result | Lawitz E, Godofsky E, Rouzier R, Marbury T, Nguyen T, Ke J, Huang M, Praestgaard J, Serra D, Evans TG. Safety, pharmacokinetics, and antiviral activity of the cyclophilin inhibitor NIM811 alone or in combination with pegylated interferon in HCV-infected patients receiving 14 days of therapy. Antiviral Res. 2011 Mar;89(3):238-45. doi: 10.1016/j.antiviral.2011.01.003. Epub 2011 Jan 19. |
| Label | URL |
|---|---|
| Results for CNIM811B2202 from the Novartis Clinical Trials website | View source |
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| Placebo BID + SOC |
| Drug |
Placebo BID + SOC (PEG IFN and RBV) |
|
| 4 weeks |
| To explore the pharmacokinetics and pharmacodynamics of NIM811 given in combination with SOC in patients with chronic hepatitis C genotype-1 | 3 weeks, 5 weeks |
| To evaluate the effect of NIM811 given in combination with SOC in patients with chronic hepatitis C genotype-1 on sustained virologic response 12 weeks after cessation of treatment (SVR12) | 12 weeks after cessation of treatment |
| Orlando |
| Florida |
| 32809 |
| United States |
| University Hepatitis Center | Sarasota | Florida | 34243 | United States |
| West Wind'r Research & Development LLC | Tampa | Florida | 33607 | United States |
| Alamo Medical Research | San Antonio | Texas | 78215 | United States |
| Novartis Investigative Site | Clayton | New South Wales | Australia |
| Novartis Investigative Site | Westmead | New South Wales | Australia |
| Novartis Investigative Site | Wentworthville | South Australia | Australia |
| Novartis Investigative Site | Brussels | Belgium |
| Novartis Investigative Site | Leuven | 3000 | Belgium |
| Novartis Investigative Site | Frankfurt | Germany |
| Fundacion de Investigacion de Diego | San Juan | 00909 | Puerto Rico |
| Novartis Investigative Site | Barcelona | Spain |
| Novartis Investigative Site | Seville | Spain |
| Novartis Investigative Site | Taipei | ROC | Taiwan |
| Novartis Investigative Site | Kaohsiung City | Taiwan |
| ID | Term |
|---|---|
| D006521 | Hepatitis, Chronic |
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C090438 | (melle-4)cyclosporin |
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