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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03468829




Registration number
NCT03468829
Ethics application status
Date submitted
7/03/2018
Date registered
19/03/2018
Date last updated
11/03/2019

Titles & IDs
Public title
Efficacy and Safety of ALX-0171 in Adult Hematopoietic Stem Cell Transplant (HSCT) Recipients Who Present With Respiratory Syncytial Virus (RSV) Infection
Scientific title
A Randomized, Double-blind, Multicenter Study to Evaluate the Efficacy and Safety of ALX 0171 Versus Placebo, in Addition to Standard of Care, in Adults Who Have Undergone Hematopoietic Stem Cell Transplantation and Present With a Respiratory Syncytial Virus Respiratory Tract Infection
Secondary ID [1] 0 0
2017-003356-23
Secondary ID [2] 0 0
ALX0171-C204
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - ALX-0171 Dose 1
Treatment: Other - ALX-0171 Dose 2
Treatment: Other - Placebo

Experimental: ALX-0171 Dose 1 -

Experimental: ALX-0171 Dose 2 -

Placebo comparator: Placebo -


Treatment: Other: ALX-0171 Dose 1
Oral inhalation of ALX-0171 Dose 1 once daily for a maximum of 14 days

Treatment: Other: ALX-0171 Dose 2
Oral inhalation of ALX-0171 Dose 2 once daily for a maximum of 14 days

Treatment: Other: Placebo
Oral inhalation of Placebo once daily for a maximum of 14 days
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time-weighted average change from baseline in log10 RSV nasal viral load
Timepoint [1] 0 0
From Day 1 to Day 7
Secondary outcome [1] 0 0
Safety as measured by the incidence of treatment-emergent (serious) adverse events
Timepoint [1] 0 0
From Screening to Day 42
Secondary outcome [2] 0 0
Nasal RSV load parameter: time to undetectable shedding
Timepoint [2] 0 0
From Day 1 to Day 42
Secondary outcome [3] 0 0
Clinical stabilization (defined as respiratory rate <25/minute and stable oxygen saturation >92% on room air for at least 12 hours)
Timepoint [3] 0 0
From Day 1 to Day 42
Secondary outcome [4] 0 0
Number of days without oxygen or with oxygen supplementation
Timepoint [4] 0 0
From Day 1 to Day 42
Secondary outcome [5] 0 0
Progression to lower respiratory tract (LRT) disease in subjects presenting with upper respiratory tract infection (URTI) at baseline
Timepoint [5] 0 0
From Day 1 to Day 42
Secondary outcome [6] 0 0
Concentration of ALX-0171 in serum
Timepoint [6] 0 0
Day 1 to Day 14
Secondary outcome [7] 0 0
Immunogenicity as measured by the concentration of anti-ALX 0171 antibodies in serum
Timepoint [7] 0 0
From Day 1 to Day 42

Eligibility
Key inclusion criteria
1. Subject has received an HSCT using any conditioning regimen and for any underlying etiology (i.e., subject has received an autologous or allogeneic HSCT)
2. Subject is clinically diagnosed with RSV infection with new onset or acute worsening
3. Symptoms likely related to RSV infection have appeared within 5 days of screening and their severity requires initial or maintained hospitalization.
4. Documented RSV infection in the upper respiratory tract (URT)
5. Subject has:

* Diagnosis of RSV lower respiratory tract (LRT) disease or
* Diagnosis of RSV URT disease with high risk of progression to lower respiratory tract infection (LRTI)

Others as defined in the protocol
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subject has clinically significant bacteremia or fungemia within 7 days of screening
2. Subject has clinically significant bacterial, fungal or viral pneumonia
3. Subject presents evidence of shock requiring intensive care unit (ICU) monitoring and/or vasopressor treatment
4. Subject requires or is expected to require invasive mechanical ventilation or intensive non-invasive respiratory support. Standard oxygen supplementation up to 6 L/minute is permitted provided it can be interrupted for the duration of study drug administration.

Others as defined in the protocol

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
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/02/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2020
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigator site - Darlinghurst
Recruitment hospital [2] 0 0
Investigator site - Westmead
Recruitment postcode(s) [1] 0 0
- Darlinghurst
Recruitment postcode(s) [2] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Leuven
Country [2] 0 0
Spain
State/province [2] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ablynx, a Sanofi company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of the study is to evaluate the antiviral effect and safety of inhaled ALX-0171 in adults diagnosed with respiratory syncytial virus (RSV) respiratory tract infection after hematopoietic stem cell transplantation (HSCT).

The secondary objective is to assess the clinical activity, pharmacokinetics (PK), virology, and immunogenicity of inhaled ALX 0171 in adults diagnosed with RSV respiratory tract infection after HSCT.
Trial website
https://clinicaltrials.gov/study/NCT03468829
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ablynx Clinical Department
Address 0 0
Ablynx, a Sanofi company
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/NCT03468829