- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01065935
Phase 2b Study of ALN-RSV01 in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)
January 31, 2018 updated by: Alnylam Pharmaceuticals
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)
To evaluate the efficacy and safety of ALN-RSV01 plus standard of care in RSV infected lung transplant patients
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
87
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New South Wales
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Darlinghurst, New South Wales, Australia, 2010
- Clinical Site
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South Australia
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Adelaide, South Australia, Australia, 5000
- Clinical Site
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Victoria
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Melbourne, Victoria, Australia, 3004
- Clinical Site
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Western Australia
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Perth, Western Australia, Australia, 6001
- Clinical Site
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Vienna, Austria, 1090
- Clinical Site
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Alberta
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Edmonton, Alberta, Canada, T6G 2E1
- Clinical Site
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Ontario
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Toronto, Ontario, Canada, M5G 2N2
- Clinical Site
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Paris, France, 75908
- Clinical Site
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Strasbourg Cedex, France, 67091
- Clinical Site
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Berlin, Germany, 10117
- Clinical Site
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Essen, Germany, 45239
- Clinical Site
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Hamburg, Germany, 20246
- Clinical Site
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Hannover, Germany, 30625
- Clinical Site
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Homburg/Saar, Germany, 66421
- Clinical Site
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Leipzig, Germany, 04103
- Clinical Site
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Arizona
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Phoenix, Arizona, United States, 85013
- Clinical Site
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California
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Los Angeles, California, United States, 90033
- Clinical Site
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Colorado
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Denver, Colorado, United States, 80202
- Clinical Site
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Florida
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Tampa, Florida, United States, 33606
- Clinical Site
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Georgia
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Atlanta, Georgia, United States, 30322
- Clinical Site
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Illinois
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Chicago, Illinois, United States, 60153
- Clinical Site
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Chicago, Illinois, United States, 60637
- Clinical Site
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Clinical Site
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Boston, Massachusetts, United States, 02115
- Clinical Site
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Michigan
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Ann Arbor, Michigan, United States, 48109
- Clinical Site
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Missouri
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Saint Louis, Missouri, United States, 63110
- Clinical Site
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New York
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New York, New York, United States, 10032
- Clinical Site
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Ohio
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Cleveland, Ohio, United States, 44195
- Clinical Site
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Clinical Site
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Pittsburgh, Pennsylvania, United States, 15213
- Clinical Site
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Tennessee
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Nashville, Tennessee, United States, 37232
- Clinical Site
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Texas
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Dallas, Texas, United States, 75390
- Clinical Site
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Houston, Texas, United States, 77030
- Clinical Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Normal saline
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Administered by nebulization once daily for 5 days
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Active Comparator: ALN-RSV01
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Administered by nebulization once daily for 5 days
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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The occurrence of new or progressive BOS grade 0p through 3 in RSV-infected lung transplant recipients
Time Frame: 180 days after randomization
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180 days after randomization
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Proportion of patients with FEV1 >80% of pre-infection baseline value
Time Frame: 90 and 180 days after randomization
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90 and 180 days after randomization
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RSV symptoms as measured by mean cumulative daily total symptom score
Time Frame: 14 days after randomization
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14 days after randomization
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Viral load as measured by viral area under the curve (AUC)
Time Frame: 6 days after randomization
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6 days after randomization
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All cause mortality
Time Frame: Throughout the study
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Throughout the study
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Martin Zamora, MD, University of Colorado, Denver
- Principal Investigator: Alan Glanville, MB BS MD Syd, FRACP, St. Vincents Hospital NSW W Australia
- Principal Investigator: Jens T Gottlieb, MD, Hannover Medical School
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
May 1, 2012
Study Registration Dates
First Submitted
February 5, 2010
First Submitted That Met QC Criteria
February 8, 2010
First Posted (Estimate)
February 10, 2010
Study Record Updates
Last Update Posted (Actual)
February 5, 2018
Last Update Submitted That Met QC Criteria
January 31, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALN-RSV01-109
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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