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

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ClinicalTrials.gov Identifier: NCT01065935
Recruitment Status : Completed
First Posted : February 10, 2010
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Alnylam Pharmaceuticals

Brief Summary:
To evaluate the efficacy and safety of ALN-RSV01 plus standard of care in RSV infected lung transplant patients

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus Infections Drug: ALN-RSV01 Drug: Normal Saline Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : February 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ALN-RSV01 Drug: ALN-RSV01
Administered by nebulization once daily for 5 days

Placebo Comparator: Normal saline Drug: Normal Saline
Administered by nebulization once daily for 5 days




Primary Outcome Measures :
  1. 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 Measures :
  1. Proportion of patients with FEV1 >80% of pre-infection baseline value [ Time Frame: 90 and 180 days after randomization ]
  2. RSV symptoms as measured by mean cumulative daily total symptom score [ Time Frame: 14 days after randomization ]
  3. Viral load as measured by viral area under the curve (AUC) [ Time Frame: 6 days after randomization ]
  4. All cause mortality [ Time Frame: Throughout the study ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01065935


Locations
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United States, Arizona
Clinical Site
Phoenix, Arizona, United States, 85013
United States, California
Clinical Site
Los Angeles, California, United States, 90033
United States, Colorado
Clinical Site
Denver, Colorado, United States, 80202
United States, Florida
Clinical Site
Tampa, Florida, United States, 33606
United States, Georgia
Clinical Site
Atlanta, Georgia, United States, 30322
United States, Illinois
Clinical Site
Chicago, Illinois, United States, 60153
Clinical Site
Chicago, Illinois, United States, 60637
United States, Massachusetts
Clinical Site
Boston, Massachusetts, United States, 02114
Clinical Site
Boston, Massachusetts, United States, 02115
United States, Michigan
Clinical Site
Ann Arbor, Michigan, United States, 48109
United States, Missouri
Clinical Site
Saint Louis, Missouri, United States, 63110
United States, New York
Clinical Site
New York, New York, United States, 10032
United States, Ohio
Clinical Site
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Clinical Site
Philadelphia, Pennsylvania, United States, 19104
Clinical Site
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Clinical Site
Nashville, Tennessee, United States, 37232
United States, Texas
Clinical Site
Dallas, Texas, United States, 75390
Clinical Site
Houston, Texas, United States, 77030
Australia, New South Wales
Clinical Site
Darlinghurst, New South Wales, Australia, 2010
Australia, South Australia
Clinical Site
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Clinical Site
Melbourne, Victoria, Australia, 3004
Australia, Western Australia
Clinical Site
Perth, Western Australia, Australia, 6001
Austria
Clinical Site
Vienna, Austria, 1090
Canada, Alberta
Clinical Site
Edmonton, Alberta, Canada, T6G 2E1
Canada, Ontario
Clinical Site
Toronto, Ontario, Canada, M5G 2N2
France
Clinical Site
Paris, France, 75908
Clinical Site
Strasbourg Cedex, France, 67091
Germany
Clinical Site
Berlin, Germany, 10117
Clinical Site
Essen, Germany, 45239
Clinical Site
Hamburg, Germany, 20246
Clinical Site
Hannover, Germany, 30625
Clinical Site
Homburg/Saar, Germany, 66421
Clinical Site
Leipzig, Germany, 04103
Sponsors and Collaborators
Alnylam Pharmaceuticals
Investigators
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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
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Responsible Party: Alnylam Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01065935    
Other Study ID Numbers: ALN-RSV01-109
First Posted: February 10, 2010    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: January 2018
Keywords provided by Alnylam Pharmaceuticals:
ALN-RSV01
RSV
Respiratory Syncytial Virus
Additional relevant MeSH terms:
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Respiratory Syncytial Virus Infections
Virus Diseases
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections