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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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/ct2/show/NCT00658086
Trial related presentations / publications
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/ct2/show/NCT00658086