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
  Purpose

To evaluate the efficacy and safety of ALN-RSV01 plus standard of care in RSV infected lung transplant patients


Condition Intervention Phase
Respiratory Syncytial Virus Infections
Drug: ALN-RSV01
Drug: Normal Saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Alnylam Pharmaceuticals:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 87
Study Start Date: February 2010
Study Completion Date: May 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Alnylam Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01065935     History of Changes
Other Study ID Numbers: ALN-RSV01-109
Study First Received: February 5, 2010
Last Updated: May 30, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices
Australia: Department of Health and Ageing Therapeutic Goods Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Austria: Agency for Health and Food Safety

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

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

ClinicalTrials.gov processed this record on April 17, 2014