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This Phase 2, open label, randomized study will investigate the virologic benefit, clinical efficacy, safety, and tolerability of amantadine and ribavirin with oseltamivir (TCAD) versus oseltamivir monotherapy for the treatment of all strains of influenza A in immunocompromised adult and pediatric subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADS-8902 | Experimental | Amantadine and Ribavirin administered with Oseltamivir phosphate |
|
| Comparator | Active Comparator | Oseltamivir Phosphate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oseltamivir Phosphate | Drug | Oseltamivir Phosphate, q8h |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to clearing of viral shedding | Baseline, Days 2, 4, 6, 8, 10, 15 and 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to alleviation of influenza clinical symptoms | Baseline, Days 2, 4, 6, 8, 10, 15, 20, 38 | |
| Proportion of subjects who enter the study with mild to moderate influenza and progress to severe influenza | Baseline, Days 2, 4, 6, 8, 10, 15, 20, 38 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adamas Investigational Site | San Francisco | California | 94114 | United States | ||
| Adamas Investigational Site |
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| ADS-8902 | Drug | Amantadine Hydrochloride, Ribavirin administered with Oseltamivir Phosphate, q8h |
|
|
| Proportion of subjects with a treatment-sensitive influenza A strain at baseline who develop a resistant strain during treatment | Baseline, Days 2, 4, 6, 8, 10, 15, 20 |
| Safety and tolerability (adverse events (AEs), AEs resulting in treatment discontinuation, and Serious AEs) | Through day 210 |
| San Francisco |
| California |
| 94115 |
| United States |
| Adamas Investigational Site | San Francisco | California | United States |
| Adamas Investigational Site | Hollywood | Florida | United States |
| Adamas Investigational Site | Miramar | Florida | United States |
| Adamas Investigational Site | Pinellas Park | Florida | United States |
| Adamas Investigational Site | Honolulu | Hawaii | United States |
| Adamas Investigational Site | Owensboro | Kentucky | United States |
| Adamas Investigational Site | New Orleans | Louisiana | United States |
| Adamas Investigational Site | Las Vegas | Nevada | United States |
| Adamas Investigational Site | New York | New York | United States |
| Adamas Investigational Site | Rapid City | South Dakota | 57702 | United States |
| Adamas Investigational Site | Memphis | Tennessee | 38105 | United States |
| Adamas Investigational Site | Amarillo | Texas | United States |
| Adamas Investigational Site | Seattle | Washington | United States |
| Adamas Investigational Site | Tacoma | Washington | United States |
| Adamas Investigational Site | Darlinghurst | New South Wales | NSW 2010 | Australia |
| Adamas Investigational Site | Herston | New South Wales | QLD 4029 | Australia |
| Adamas Investigational Site | Sydney | New South Wales | QLD 4029 | Australia |
| Adamas Investigative Site | Parkville | Victoria | 3050 | Australia |
| Adamas Investigational Site | Melbourne | Australia |
| Adamas Investigational Site | Edmonton | Alberta | Canada |
| Adamas Investigational Site | Toronto | Ontario | Canada |
| Adamas Investigational Site | Leiden | Netherlands |
| Adamas Investigational Site | Singapore | Singapore |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D053139 | Oseltamivir |
| D000547 | Amantadine |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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