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

January 31, 2018 updated by: Alnylam Pharmaceuticals

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Clinical Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Clinical Site
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Clinical Site
    • Western Australia
      • Perth, Western Australia, Australia, 6001
        • Clinical Site
  • Austria
      • Vienna, Austria, 1090
        • Clinical Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2E1
        • Clinical Site
    • Ontario
      • Toronto, Ontario, Canada, M5G 2N2
        • Clinical Site
  • France
      • Paris, France, 75908
        • Clinical Site
      • Strasbourg Cedex, France, 67091
        • Clinical Site
  • Germany
      • Berlin, Germany, 10117
        • Clinical Site
      • Essen, Germany, 45239
        • Clinical Site
      • Hamburg, Germany, 20246
        • Clinical Site
      • Hannover, Germany, 30625
        • Clinical Site
      • Homburg/Saar, Germany, 66421
        • Clinical Site
      • Leipzig, Germany, 04103
        • Clinical Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Clinical Site
    • California
      • Los Angeles, California, United States, 90033
        • Clinical Site
    • Colorado
      • Denver, Colorado, United States, 80202
        • Clinical Site
    • Florida
      • Tampa, Florida, United States, 33606
        • Clinical Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Clinical Site
    • Illinois
      • Chicago, Illinois, United States, 60153
        • Clinical Site
      • Chicago, Illinois, United States, 60637
        • Clinical Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Clinical Site
      • Boston, Massachusetts, United States, 02115
        • Clinical Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Clinical Site
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Clinical Site
    • New York
      • New York, New York, United States, 10032
        • Clinical Site
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Clinical Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Clinical Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • Clinical Site
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Clinical Site
    • Texas
      • Dallas, Texas, United States, 75390
        • Clinical Site
      • Houston, Texas, United States, 77030
        • Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Normal saline
Drug: Normal Saline
Administered by nebulization once daily for 5 days
Active Comparator: ALN-RSV01
Drug: ALN-RSV01
Administered by nebulization once daily for 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The occurrence of new or progressive BOS grade 0p through 3 in RSV-infected lung transplant recipients
Time Frame: 180 days after randomization
180 days after randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with FEV1 >80% of pre-infection baseline value
Time Frame: 90 and 180 days after randomization
90 and 180 days after randomization
RSV symptoms as measured by mean cumulative daily total symptom score
Time Frame: 14 days after randomization
14 days after randomization
Viral load as measured by viral area under the curve (AUC)
Time Frame: 6 days after randomization
6 days after randomization
All cause mortality
Time Frame: Throughout the study
Throughout the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

February 5, 2010

First Submitted That Met QC Criteria

February 8, 2010

First Posted (Estimate)

February 10, 2010

Study Record Updates

Last Update Posted (Actual)

February 5, 2018

Last Update Submitted That Met QC Criteria

January 31, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALN-RSV01-109

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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