NCT00658086

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2008

Shorter than P25 for phase_2

Geographic Reach
2 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 14, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

January 29, 2018

Status Verified

January 1, 2018

Enrollment Period

1 year

First QC Date

April 9, 2008

Last Update Submit

January 26, 2018

Conditions

Respiratory Syncytial Virus Infections

Keywords

ALN-RSV01Respiratory Syncytial Virus

Outcome Measures

Primary Outcomes (1)

  • Assess safety and tolerability of aerosolized ALN-RSV01 versus placebo in lung transplant patients infected with RSV

    Day 30

Secondary Outcomes (1)

  • Evaluate effects of ALN-RSV01 on clinical and virologic endpoints

    Throughout Trial

Study Arms (2)

1

ACTIVE COMPARATOR

ALN-RSV01

Drug: ALN-RSV01

2

PLACEBO COMPARATOR

Normal saline

Drug: normal saline

Interventions

ALN-RSV01DRUG

administered by nebulization once daily for 3 days

1
normal salineDRUG

administered by nebulization once daily for 3 days

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Clinical Site

San Diego, California, 92103, United States

Location

Clinical Site

San Francisco, California, 94143, United States

Location

Clinical Site

Denver, Colorado, 80262, United States

Location

Clinical Site

Gainesville, Florida, United States

Location

Clinical Site

Atlanta, Georgia, United States

Location

Clinical Site

Chicago, Illinois, United States

Location

Clinical Site

Boston, Massachusetts, United States

Location

Clinical Site

Minneapolis, Minnesota, 55455, United States

Location

Clinical Site

Cleveland, Ohio, 44195, United States

Location

Clinical Site

Nashville, Tennessee, 37232, United States

Location

Clinical Site

Sydney, New South Wales, Australia

Location

Clinical Site

Brisbane, Queensland, Australia

Location

Clinical Site

Perth, Western Australia, Australia

Location

Related Publications (1)

  • Zamora MR, Budev M, Rolfe M, Gottlieb J, Humar A, Devincenzo J, Vaishnaw A, Cehelsky J, Albert G, Nochur S, Gollob JA, Glanville AR. RNA interference therapy in lung transplant patients infected with respiratory syncytial virus. Am J Respir Crit Care Med. 2011 Feb 15;183(4):531-8. doi: 10.1164/rccm.201003-0422OC. Epub 2010 Sep 17.

    PMID: 20851929DERIVED

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Pneumovirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Martin Zamora, MD

    University of Colorado Health Science Center

    PRINCIPAL INVESTIGATOR

  • Allan Glanville, MB BS MD Syd, FRACP

    St. Vincent's Hospital NSW Australia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 9, 2008

First Posted

April 14, 2008

Study Start

April 1, 2008

Primary Completion

April 1, 2009

Study Completion

June 1, 2009

Last Updated

January 29, 2018

Record last verified: 2018-01

Locations

US(10)AU(3)