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

January 26, 2018 updated by: Alnylam Pharmaceuticals

A Multi-Center, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety and Antiviral Activity of Aerosolized ALN-RSV01 Plus Standard of Care in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)

To evaluate the safety,tolerability and antiviral activitity of ALN-RSV01 in RSV infected lung transplant patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

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
      • Sydney, New South Wales, Australia
        • Clinical Site
    • Queensland
      • Brisbane, Queensland, Australia
        • Clinical Site
    • Western Australia
      • Perth, Western Australia, Australia
        • Clinical Site
  • United States
    • California
      • San Diego, California, United States, 92103
        • Clinical Site
      • San Francisco, California, United States, 94143
        • Clinical Site
    • Colorado
      • Denver, Colorado, United States, 80262
        • Clinical Site
    • Florida
      • Gainesville, Florida, United States
        • Clinical Site
    • Georgia
      • Atlanta, Georgia, United States
        • Clinical Site
    • Illinois
      • Chicago, Illinois, United States
        • Clinical Site
    • Massachusetts
      • Boston, Massachusetts, United States
        • Clinical Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Clinical Site
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Clinical Site
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • 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

18 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 1 month

Exclusion Criteria:

  • Antimicrobial therapy for known viral, bacterial, or fungal respiratory co-infection at the time of diagnosis
  • Bronchiolitis obliterans syndrome (BOS) Grade 3 or any state 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) or thymoglobulin within 3 months of screening: concurrent use of >= 0.3 mg/kg/day prednisone or equivalent as maintenance therapy
  • active treament 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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
ALN-RSV01
Drug: ALN-RSV01
administered by nebulization once daily for 3 days
PLACEBO_COMPARATOR: 2
Normal saline
Drug: normal saline
administered by nebulization once daily for 3 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assess safety and tolerability of aerosolized ALN-RSV01 versus placebo in lung transplant patients infected with RSV
Time Frame: Day 30
Day 30

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate effects of ALN-RSV01 on clinical and virologic endpoints
Time Frame: Throughout Trial
Throughout Trial

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 Health Science Center
  • Principal Investigator: Allan Glanville, MB BS MD Syd, FRACP, St. Vincent's Hospital NSW Australia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2008

Primary Completion (ACTUAL)

April 1, 2009

Study Completion (ACTUAL)

June 1, 2009

Study Registration Dates

First Submitted

April 9, 2008

First Submitted That Met QC Criteria

April 11, 2008

First Posted (ESTIMATE)

April 14, 2008

Study Record Updates

Last Update Posted (ACTUAL)

January 29, 2018

Last Update Submitted That Met QC Criteria

January 26, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALN-RSV01-106

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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