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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 2, 2018
Sponsor:
Information provided by (Responsible Party):
Alnylam Pharmaceuticals

Study Description
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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

Study Design
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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

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U.S. FDA Resources

Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Contacts and Locations
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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


  Show 33 Study Locations
Sponsors and Collaborators
Alnylam Pharmaceuticals
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
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Alnylam Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01065935     History of Changes
Other Study ID Numbers: ALN-RSV01-109
First Posted: February 10, 2010    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: January 2018

Keywords provided by Alnylam Pharmaceuticals:
ALN-RSV01
RSV
Respiratory Syncytial Virus

Additional relevant MeSH terms:
Virus Diseases
Respiratory Syncytial Virus Infections
Pneumovirus Infections
 Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections