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

Alnylam Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Respiratory Syncytial Virus Infections

Treatments: Drug: Normal Saline; Drug: ALN-RSV01

Study type: Interventional

Funder types: Industry

Identifiers

NCT01065935

ALN-RSV01-109

Details and patient eligibility

About

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

Enrollment: 87 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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87 participants in 2 patient groups, including a placebo group

ALN-RSV01

Active Comparator group

Treatment:

Drug: ALN-RSV01

Normal saline

Placebo Comparator group

Treatment:

Drug: Normal Saline