Phase 2 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

NCT00658086

ALN-RSV01-106

Details and patient eligibility

About

To evaluate the safety,tolerability and antiviral activitity of ALN-RSV01 in RSV infected lung transplant patients

Enrollment: 24 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 1 month

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

ALN-RSV01

Treatment:

Drug: ALN-RSV01

2

Placebo Comparator group

Description:

Normal saline

Treatment:

Drug: normal saline