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To evaluate the safety,tolerability and antiviral activitity of ALN-RSV01 in RSV infected lung transplant patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | ALN-RSV01 |
|
| 2 | Placebo Comparator | Normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALN-RSV01 | Drug | administered by nebulization once daily for 3 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Assess safety and tolerability of aerosolized ALN-RSV01 versus placebo in lung transplant patients infected with RSV | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate effects of ALN-RSV01 on clinical and virologic endpoints | Throughout Trial |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Zamora, MD | University of Colorado Health Science Center | Principal Investigator |
| Allan Glanville, MB BS MD Syd, FRACP | St. Vincent's Hospital NSW Australia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Site | San Diego | California | 92103 | United States | ||
| Clinical Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20851929 | Derived | Zamora MR, Budev M, Rolfe M, Gottlieb J, Humar A, Devincenzo J, Vaishnaw A, Cehelsky J, Albert G, Nochur S, Gollob JA, Glanville AR. RNA interference therapy in lung transplant patients infected with respiratory syncytial virus. Am J Respir Crit Care Med. 2011 Feb 15;183(4):531-8. doi: 10.1164/rccm.201003-0422OC. Epub 2010 Sep 17. |
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| normal saline |
| Drug |
administered by nebulization once daily for 3 days |
|
| San Francisco |
| California |
| 94143 |
| United States |
| Clinical Site | Denver | Colorado | 80262 | United States |
| Clinical Site | Gainesville | Florida | United States |
| Clinical Site | Atlanta | Georgia | United States |
| Clinical Site | Chicago | Illinois | United States |
| Clinical Site | Boston | Massachusetts | United States |
| Clinical Site | Minneapolis | Minnesota | 55455 | United States |
| Clinical Site | Cleveland | Ohio | 44195 | United States |
| Clinical Site | Nashville | Tennessee | 37232 | United States |
| Clinical Site | Sydney | New South Wales | Australia |
| Clinical Site | Brisbane | Queensland | Australia |
| Clinical Site | Perth | Western Australia | Australia |
| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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