Clinical trial NCT03468829: Efficacy and Safety of ALX-0171 in Adult Hematopoietic Stem Cell Transplant (HSCT) Recipients Who Present With Respiratory Syncytial Virus (RSV) Infection
Official 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Respiratory Syncytial Virus Lower Respiratory Tract Infection
Lead sponsor: Ablynx, a Sanofi company
Sponsor class: INDUSTRY
First posted: 2018-03-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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

Primary outcomes:
measure: Time-weighted average change from baseline in log10 RSV nasal viral load
timeFrame: From Day 1 to Day 7
Secondary outcomes:
measure: Safety as measured by the incidence of treatment-emergent (serious) adverse events
timeFrame: From Screening to Day 42
measure: Nasal RSV load parameter: time to undetectable shedding
timeFrame: From Day 1 to Day 42
measure: Clinical stabilization (defined as respiratory rate <25/minute and stable oxygen saturation >92% on room air for at least 12 hours)
timeFrame: From Day 1 to Day 42
measure: Number of days without oxygen or with oxygen supplementation
timeFrame: From Day 1 to Day 42
measure: Progression to lower respiratory tract (LRT) disease in subjects presenting with upper respiratory tract infection (URTI) at baseline
timeFrame: From Day 1 to Day 42
measure: Concentration of ALX-0171 in serum
timeFrame: Day 1 to Day 14
measure: Immunogenicity as measured by the concentration of anti-ALX 0171 antibodies in serum
timeFrame: From Day 1 to Day 42
Other outcomes:
Locations:
city: Darlinghurst
country: Australia
facility: Investigator site
city: Westmead
country: Australia
facility: Investigator site
city: Leuven
country: Belgium
facility: Investigator site
city: Valencia
country: Spain
facility: Investigator site 1
city: Valencia
country: Spain
facility: Investigator site 2
Study officials:
affiliation: Ablynx, a Sanofi company
name: Ablynx Clinical Department
role: STUDY_DIRECTOR
References: