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

Respiratory Syncytial Virus Infections Clinical Trial

Official title:

A Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety 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: NCT01065935
• Other study ID #: ALN-RSV01-109
• Status: Completed
• Phase: Phase 2
• First received: February 5, 2010
• Last updated: January 31, 2018
• Start date: February 2010
• Est. completion date: May 2012

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: May 2012
• Est. primary completion date: April 2012
• 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 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

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infections
• Virus Diseases

Intervention

Drug:
• ALN-RSV01
Administered by nebulization once daily for 5 days
• Normal Saline
Administered by nebulization once daily for 5 days

Locations

Country	Name	City	State
Australia	Clinical Site	Adelaide	South Australia
Australia	Clinical Site	Darlinghurst	New South Wales
Australia	Clinical Site	Melbourne	Victoria
Australia	Clinical Site	Perth	Western Australia
Austria	Clinical Site	Vienna
Canada	Clinical Site	Edmonton	Alberta
Canada	Clinical Site	Toronto	Ontario
France	Clinical Site	Paris
France	Clinical Site	Strasbourg Cedex
Germany	Clinical Site	Berlin
Germany	Clinical Site	Essen
Germany	Clinical Site	Hamburg
Germany	Clinical Site	Hannover
Germany	Clinical Site	Homburg/Saar
Germany	Clinical Site	Leipzig
United States	Clinical Site	Ann Arbor	Michigan
United States	Clinical Site	Atlanta	Georgia
United States	Clinical Site	Boston	Massachusetts
United States	Clinical Site	Boston	Massachusetts
United States	Clinical Site	Chicago	Illinois
United States	Clinical Site	Chicago	Illinois
United States	Clinical Site	Cleveland	Ohio
United States	Clinical Site	Dallas	Texas
United States	Clinical Site	Denver	Colorado
United States	Clinical Site	Houston	Texas
United States	Clinical Site	Los Angeles	California
United States	Clinical Site	Nashville	Tennessee
United States	Clinical Site	New York	New York
United States	Clinical Site	Philadelphia	Pennsylvania
United States	Clinical Site	Phoenix	Arizona
United States	Clinical Site	Pittsburgh	Pennsylvania
United States	Clinical Site	Saint Louis	Missouri
United States	Clinical Site	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Alnylam Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The occurrence of new or progressive BOS grade 0p through 3 in RSV-infected lung transplant recipients		180 days after randomization
Secondary	Proportion of patients with FEV1 >80% of pre-infection baseline value		90 and 180 days after randomization
Secondary	RSV symptoms as measured by mean cumulative daily total symptom score		14 days after randomization
Secondary	Viral load as measured by viral area under the curve (AUC)		6 days after randomization
Secondary	All cause mortality		Throughout the study