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

Respiratory Syncytial Virus Infections Clinical Trial

Official title:

A Multi-Center, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety and Antiviral Activity of Aerosolized ALN-RSV01 Plus Standard of Care in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00658086
• Other study ID #: ALN-RSV01-106
• Status: Completed
• Phase: Phase 2
• First received: April 9, 2008
• Last updated: January 26, 2018
• Start date: April 2008
• Est. completion date: June 2009

Study information

• Verified date: January 2018
• Source: Alnylam Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infections
• Virus Diseases

Intervention

Drug:
• ALN-RSV01
administered by nebulization once daily for 3 days
• normal saline
administered by nebulization once daily for 3 days

Locations

Country	Name	City	State
Australia	Clinical Site	Brisbane	Queensland
Australia	Clinical Site	Perth	Western Australia
Australia	Clinical Site	Sydney	New South Wales
United States	Clinical Site	Atlanta	Georgia
United States	Clinical Site	Boston	Massachusetts
United States	Clinical Site	Chicago	Illinois
United States	Clinical Site	Cleveland	Ohio
United States	Clinical Site	Denver	Colorado
United States	Clinical Site	Gainesville	Florida
United States	Clinical Site	Minneapolis	Minnesota
United States	Clinical Site	Nashville	Tennessee
United States	Clinical Site	San Diego	California
United States	Clinical Site	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Alnylam Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess safety and tolerability of aerosolized ALN-RSV01 versus placebo in lung transplant patients infected with RSV		Day 30
Secondary	Evaluate effects of ALN-RSV01 on clinical and virologic endpoints		Throughout Trial