Phase 2b Study of ALN-RSV01 in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)
Phase 2
Completed
- Conditions
- Respiratory Syncytial Virus Infections
- Interventions
- Drug: Normal Saline
- Registration Number
- NCT01065935
- Lead Sponsor
- Alnylam Pharmaceuticals
- Brief Summary
To evaluate the efficacy and safety of ALN-RSV01 plus standard of care in RSV infected lung transplant patients
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 87
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Normal saline Normal Saline - ALN-RSV01 ALN-RSV01 -
- Primary Outcome Measures
Name Time Method The occurrence of new or progressive BOS grade 0p through 3 in RSV-infected lung transplant recipients 180 days after randomization
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Clinical Site
🇩🇪Leipzig, Germany