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Phase 2b 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: NCT01065935
Recruitment Status : Completed
First Posted : February 10, 2010
Last Update Posted : February 2, 2018
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 ]

Information from the National Library of Medicine

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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 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 identifier (NCT number): NCT01065935

  Show 33 Study Locations
Sponsors and Collaborators
Alnylam Pharmaceuticals
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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 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:
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