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

Primary Purpose

Respiratory Syncytial Virus Infections

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ALN-RSV01
normal saline
Sponsored by
Alnylam Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Syncytial Virus Infections focused on measuring ALN-RSV01, Respiratory Syncytial Virus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

ALN-RSV01

Normal saline

Outcomes

Primary Outcome Measures

Assess safety and tolerability of aerosolized ALN-RSV01 versus placebo in lung transplant patients infected with RSV

Secondary Outcome Measures

Evaluate effects of ALN-RSV01 on clinical and virologic endpoints

Full Information

First Posted
April 9, 2008
Last Updated
January 26, 2018
Sponsor
Alnylam Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00658086
Brief Title
Phase 2 Study of ALN-RSV01 in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Alnylam Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus Infections
Keywords
ALN-RSV01, Respiratory Syncytial Virus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
ALN-RSV01
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Normal saline
Intervention Type
Drug
Intervention Name(s)
ALN-RSV01
Intervention Description
administered by nebulization once daily for 3 days
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
administered by nebulization once daily for 3 days
Primary Outcome Measure Information:
Title
Assess safety and tolerability of aerosolized ALN-RSV01 versus placebo in lung transplant patients infected with RSV
Time Frame
Day 30
Secondary Outcome Measure Information:
Title
Evaluate effects of ALN-RSV01 on clinical and virologic endpoints
Time Frame
Throughout Trial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Zamora, MD
Organizational Affiliation
University of Colorado Health Science Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Allan Glanville, MB BS MD Syd, FRACP
Organizational Affiliation
St. Vincent's Hospital NSW Australia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Clinical Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Clinical Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Clinical Site
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
Clinical Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Clinical Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Clinical Site
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Clinical Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Clinical Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Clinical Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Clinical Site
City
Sydney
State/Province
New South Wales
Country
Australia
Facility Name
Clinical Site
City
Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Clinical Site
City
Perth
State/Province
Western Australia
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
20851929
Citation
Zamora MR, Budev M, Rolfe M, Gottlieb J, Humar A, Devincenzo J, Vaishnaw A, Cehelsky J, Albert G, Nochur S, Gollob JA, Glanville AR. RNA interference therapy in lung transplant patients infected with respiratory syncytial virus. Am J Respir Crit Care Med. 2011 Feb 15;183(4):531-8. doi: 10.1164/rccm.201003-0422OC. Epub 2010 Sep 17.
Results Reference
derived

Learn more about this trial

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

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