Status:
COMPLETED
Phase 2 Study of ALN-RSV01 in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)
Lead Sponsor:
Alnylam Pharmaceuticals
Conditions:
Respiratory Syncytial Virus Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To evaluate the safety,tolerability and antiviral activitity of ALN-RSV01 in RSV infected lung transplant patients
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00658086
Start Date
April 1 2008
End Date
June 1 2009
Last Update
January 29 2018
Active Locations (13)
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1
Clinical Site
San Diego, California, United States, 92103
2
Clinical Site
San Francisco, California, United States, 94143
3
Clinical Site
Denver, Colorado, United States, 80262
4
Clinical Site
Gainesville, Florida, United States