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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00658086
Recruitment Status : Completed
First Posted : April 14, 2008
Last Update Posted : January 29, 2018
Information provided by:
Alnylam Pharmaceuticals

Brief Summary:
To evaluate the safety,tolerability and antiviral activitity of ALN-RSV01 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 : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : April 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
Drug: ALN-RSV01
administered by nebulization once daily for 3 days

Placebo Comparator: 2
Normal saline
Drug: normal saline
administered by nebulization once daily for 3 days

Primary Outcome Measures :
  1. Assess safety and tolerability of aerosolized ALN-RSV01 versus placebo in lung transplant patients infected with RSV [ Time Frame: Day 30 ]

Secondary Outcome Measures :
  1. Evaluate effects of ALN-RSV01 on clinical and virologic endpoints [ Time Frame: Throughout Trial ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

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 identifier (NCT number): NCT00658086

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United States, California
Clinical Site
San Diego, California, United States, 92103
Clinical Site
San Francisco, California, United States, 94143
United States, Colorado
Clinical Site
Denver, Colorado, United States, 80262
United States, Florida
Clinical Site
Gainesville, Florida, United States
United States, Georgia
Clinical Site
Atlanta, Georgia, United States
United States, Illinois
Clinical Site
Chicago, Illinois, United States
United States, Massachusetts
Clinical Site
Boston, Massachusetts, United States
United States, Minnesota
Clinical Site
Minneapolis, Minnesota, United States, 55455
United States, Ohio
Clinical Site
Cleveland, Ohio, United States, 44195
United States, Tennessee
Clinical Site
Nashville, Tennessee, United States, 37232
Australia, New South Wales
Clinical Site
Sydney, New South Wales, Australia
Australia, Queensland
Clinical Site
Brisbane, Queensland, Australia
Australia, Western Australia
Clinical Site
Perth, Western Australia, Australia
Sponsors and Collaborators
Alnylam Pharmaceuticals
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Principal Investigator: Martin Zamora, MD University of Colorado Health Science Center
Principal Investigator: Allan Glanville, MB BS MD Syd, FRACP St. Vincent's Hospital NSW Australia

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jared Gollob, MD Sr. Director Clinical Research, Alnylam Pharmaceuticals Identifier: NCT00658086     History of Changes
Other Study ID Numbers: ALN-RSV01-106
First Posted: April 14, 2008    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018
Keywords provided by Alnylam Pharmaceuticals:
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