Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00658086




Registration number
NCT00658086
Ethics application status
Date submitted
9/04/2008
Date registered
14/04/2008
Date last updated
29/01/2018

Titles & IDs
Public title
Phase 2 Study of ALN-RSV01 in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)
Scientific title
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)
Secondary ID [1] 0 0
ALN-RSV01-106
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infections 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ALN-RSV01
Treatment: Drugs - normal saline

Active comparator: 1 - ALN-RSV01

Placebo comparator: 2 - Normal saline


Treatment: Drugs: ALN-RSV01
administered by nebulization once daily for 3 days

Treatment: Drugs: normal saline
administered by nebulization once daily for 3 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Assess safety and tolerability of aerosolized ALN-RSV01 versus placebo in lung transplant patients infected with RSV
Timepoint [1] 0 0
Day 30
Secondary outcome [1] 0 0
Evaluate effects of ALN-RSV01 on clinical and virologic endpoints
Timepoint [1] 0 0
Throughout Trial

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2009
Sample size
Target
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
Clinical Site - Sydney
Recruitment hospital [2] 0 0
Clinical Site - Brisbane
Recruitment hospital [3] 0 0
Clinical Site - Perth
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Alnylam Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To evaluate the safety,tolerability and antiviral activitity of ALN-RSV01 in RSV infected lung transplant patients
Trial website
https://clinicaltrials.gov/study/NCT00658086
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Martin Zamora, MD
Address 0 0
University of Colorado Health Science Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00658086