NCT01065935CompletedPhase 2
A Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Aerosolized ALN-RSV01 Plus Standard of Care in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)
Alnylam Pharmaceuticals1 site in 1 country87 target enrollmentStarted: February 2010Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 87
- Locations
- 1
- Primary Endpoint
- The occurrence of new or progressive BOS grade 0p through 3 in RSV-infected lung transplant recipients
Study Overview
Brief Summary
To evaluate the efficacy and safety of ALN-RSV01 plus standard of care in RSV infected lung transplant patients
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
ALN-RSV01
Active Comparator
Intervention: ALN-RSV01 (Drug)
Normal saline
Placebo Comparator
Intervention: Normal Saline (Drug)
Outcomes
Primary Outcomes
The occurrence of new or progressive BOS grade 0p through 3 in RSV-infected lung transplant recipients
Time Frame: 180 days after randomization
Secondary Outcomes
- Proportion of patients with FEV1 >80% of pre-infection baseline value(90 and 180 days after randomization)
- Viral load as measured by viral area under the curve (AUC)(6 days after randomization)
- All cause mortality(Throughout the study)
- RSV symptoms as measured by mean cumulative daily total symptom score(14 days after randomization)
Investigators
Study Sites (1)
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