Phase 2b Study of ALN-RSV01 in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy and safety of ALN-RSV01 plus standard of care in RSV infected lung transplant patients

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alnylam Pharmaceuticals

Criteria

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 30 days

Exclusion Criteria:

• Known viral, bacterial, or fungal respiratory co-infection at the time of RSV diagnosis

• Bronchiolitis obliterans syndrome (BOS) Grade 3 or any 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) within 90 days of screening or prednisone or equivalent as maintenance therapy

• Active treatment for acute graft rejection