Phase 2 Study of ALN-RSV01 in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Pulmonary |
| Therapuetic Areas: | Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/31/2018 |
| Start Date: | April 2008 |
| End Date: | June 2009 |
A Multi-Center, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety and Antiviral Activity of Aerosolized ALN-RSV01 Plus Standard of Care in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)
To evaluate the safety,tolerability and antiviral activitity of ALN-RSV01 in RSV infected
lung transplant patients
lung transplant patients
Inclusion Criteria:
- Single or bilateral lung transplant recipients
- Confirmed RSV infection
- Greater than 90 days post current lung transplant
- Rejection free for a minimum of 1 month
Exclusion Criteria:
- Antimicrobial therapy for known viral, bacterial, or fungal respiratory co-infection
at the time of diagnosis
- Bronchiolitis obliterans syndrome (BOS) Grade 3 or any state BOS with FEV1 that has
not been stable for at least 3 months
- Use of alemtuzumab within 9 months prior to screening; anti-thymocyte globulin(ATG) or
thymoglobulin within 3 months of screening: concurrent use of >= 0.3 mg/kg/day
prednisone or equivalent as maintenance therapy
- active treament for acute graft rejection
We found this trial at
11
sites
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