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

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:

MedlinePlus related topics: Lung Transplantation Respiratory Syncytial Virus Infections

U.S. FDA Resources

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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:


Virus Diseases Respiratory Syncytial Virus Infections Pneumovirus Infections	Paramyxoviridae Infections Mononegavirales Infections RNA Virus Infections

ClinicalTrials.gov processed this record on September 23, 2016