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

Completed · Phase 2

Conditions studied: Respiratory Syncytial Virus Infections

In brief

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

Key facts

Study ID

NCT01065935

Run by

Alnylam Pharmaceuticals

People needed

87

Starts

2010-02-01

Expected to finish

2012-05-01

Last updated by the study team

2018-02-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clinical Site — Phoenix, Arizona, United States
• Clinical Site — Los Angeles, California, United States
• Clinical Site — Denver, Colorado, United States
• Clinical Site — Tampa, Florida, United States
• Clinical Site — Atlanta, Georgia, United States
• Clinical Site — Chicago, Illinois, United States
• Clinical Site — Chicago, Illinois, United States
• Clinical Site — Boston, Massachusetts, United States
• Clinical Site — Boston, Massachusetts, United States
• Clinical Site — Ann Arbor, Michigan, United States
• Clinical Site — St Louis, Missouri, United States
• Clinical Site — New York, New York, United States
• Clinical Site — Cleveland, Ohio, United States
• Clinical Site — Philadelphia, Pennsylvania, United States
• Clinical Site — Pittsburgh, Pennsylvania, United States
• Clinical Site — Nashville, Tennessee, United States
• Clinical Site — Dallas, Texas, United States
• Clinical Site — Houston, Texas, United States
• Clinical Site — Darlinghurst, New South Wales, Australia
• Clinical Site — Adelaide, South Australia, Australia
• Clinical Site — Melbourne, Victoria, Australia
• Clinical Site — Perth, Western Australia, Australia
• Clinical Site — Vienna, Austria
• Clinical Site — Edmonton, Alberta, Canada
• Clinical Site — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.