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

This study has been completed.
Sponsor:
Information provided by:
Alnylam Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00658086
First received: April 9, 2008
Last updated: June 15, 2009
Last verified: June 2009
History of Changes

April 9, 2008
June 15, 2009
April 2008
April 2009   (final data collection date for primary outcome measure)
Assess safety and tolerability of aerosolized ALN-RSV01 versus placebo in lung transplant patients infected with RSV [ Time Frame: Day 30 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00658086 on ClinicalTrials.gov Archive Site
Evaluate effects of ALN-RSV01 on clinical and virologic endpoints [ Time Frame: Throughout Trial ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Phase 2 Study of ALN-RSV01 in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)
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)

To evaluate the safety,tolerability and antiviral activitity of ALN-RSV01 in RSV infected lung transplant patients
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Respiratory Syncytial Virus Infections
  • Drug: ALN-RSV01
    administered by nebulization once daily for 3 days
  • Drug: normal saline
    administered by nebulization once daily for 3 days
  • Active Comparator: 1
    ALN-RSV01
    Intervention: Drug: ALN-RSV01
  • Placebo Comparator: 2
    Normal saline
    Intervention: Drug: normal saline
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. Epub 2010 Sep 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
June 2009
April 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia
 
NCT00658086
ALN-RSV01-106
No
Jared Gollob, MD Sr. Director Clinical Research, Alnylam Pharmaceuticals
Alnylam Pharmaceuticals
Not Provided
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
Alnylam Pharmaceuticals
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP