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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alnylam Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01065935
First received: February 5, 2010
Last updated: May 30, 2012
Last verified: May 2012
History of Changes

February 5, 2010
May 30, 2012
February 2010
April 2012   (final data collection date for primary outcome measure)
The occurrence of new or progressive BOS grade 0p through 3 in RSV-infected lung transplant recipients [ Time Frame: 180 days after randomization ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01065935 on ClinicalTrials.gov Archive Site
  • Proportion of patients with FEV1 >80% of pre-infection baseline value [ Time Frame: 90 and 180 days after randomization ] [ Designated as safety issue: No ]
  • RSV symptoms as measured by mean cumulative daily total symptom score [ Time Frame: 14 days after randomization ] [ Designated as safety issue: No ]
  • Viral load as measured by viral area under the curve (AUC) [ Time Frame: 6 days after randomization ] [ Designated as safety issue: No ]
  • All cause mortality [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Phase 2b Study of ALN-RSV01 in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)
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
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 5 days
  • Drug: Normal Saline
    Administered by nebulization once daily for 5 days
  • Active Comparator: ALN-RSV01
    Intervention: Drug: ALN-RSV01
  • Placebo Comparator: Normal saline
    Intervention: Drug: Normal Saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
87
May 2012
April 2012   (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 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Canada,   France,   Germany
 
NCT01065935
ALN-RSV01-109
Yes
Alnylam Pharmaceuticals
Alnylam Pharmaceuticals
Not Provided
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
Alnylam Pharmaceuticals
May 2012

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