search
Back to results

Phase 2b 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, RSV, 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 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

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
  • 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
  • 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

ALN-RSV01

Normal saline

Arm Description

Outcomes

Primary Outcome Measures

The occurrence of new or progressive BOS grade 0p through 3 in RSV-infected lung transplant recipients

Secondary Outcome Measures

Proportion of patients with FEV1 >80% of pre-infection baseline value
RSV symptoms as measured by mean cumulative daily total symptom score
Viral load as measured by viral area under the curve (AUC)
All cause mortality

Full Information

First Posted
February 5, 2010
Last Updated
January 31, 2018
Sponsor
Alnylam Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT01065935
Brief Title
Phase 2b Study of ALN-RSV01 in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alnylam Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the efficacy and safety of ALN-RSV01 plus standard of care 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, RSV, 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
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ALN-RSV01
Arm Type
Active Comparator
Arm Title
Normal saline
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ALN-RSV01
Intervention Description
Administered by nebulization once daily for 5 days
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Intervention Description
Administered by nebulization once daily for 5 days
Primary Outcome Measure Information:
Title
The occurrence of new or progressive BOS grade 0p through 3 in RSV-infected lung transplant recipients
Time Frame
180 days after randomization
Secondary Outcome Measure Information:
Title
Proportion of patients with FEV1 >80% of pre-infection baseline value
Time Frame
90 and 180 days after randomization
Title
RSV symptoms as measured by mean cumulative daily total symptom score
Time Frame
14 days after randomization
Title
Viral load as measured by viral area under the curve (AUC)
Time Frame
6 days after randomization
Title
All cause mortality
Time Frame
Throughout the study

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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Zamora, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alan Glanville, MB BS MD Syd, FRACP
Organizational Affiliation
St. Vincents Hospital NSW W Australia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jens T Gottlieb, MD
Organizational Affiliation
Hannover Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Clinical Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Clinical Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80202
Country
United States
Facility Name
Clinical Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Clinical Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Clinical Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Clinical Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Clinical Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Clinical Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Clinical Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Clinical Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Clinical Site
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Clinical Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Clinical Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Clinical Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Clinical Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Clinical Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Clinical Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Clinical Site
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Clinical Site
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Clinical Site
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Clinical Site
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6001
Country
Australia
Facility Name
Clinical Site
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Clinical Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2E1
Country
Canada
Facility Name
Clinical Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
Clinical Site
City
Paris
ZIP/Postal Code
75908
Country
France
Facility Name
Clinical Site
City
Strasbourg Cedex
ZIP/Postal Code
67091
Country
France
Facility Name
Clinical Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Clinical Site
City
Essen
ZIP/Postal Code
45239
Country
Germany
Facility Name
Clinical Site
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Clinical Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Clinical Site
City
Homburg/Saar
ZIP/Postal Code
66421
Country
Germany
Facility Name
Clinical Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs