Efficacy and Safety of ALX-0171 in Adult Hematopoietic Stem Cell Transplant (HSCT) Recipients Who Present With Respiratory Syncytial Virus (RSV) Infection

Respiratory Syncytial Virus Lower Respiratory Tract Infection Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03468829
• Other study ID #: ALX0171-C204
• Secondary ID: 2017-003356-23
• Status: Withdrawn
• Phase: Phase 2
• Start date: February 2019
• Est. completion date: May 2020

Study information

• Verified date: March 2019
• Source: Ablynx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Respiratory Syncytial Virus Lower Respiratory Tract Infection
• Respiratory Tract Infections

Intervention

Biological:
• ALX-0171 Dose 1
Oral inhalation of ALX-0171 Dose 1 once daily for a maximum of 14 days
• ALX-0171 Dose 2
Oral inhalation of ALX-0171 Dose 2 once daily for a maximum of 14 days
• Placebo
Oral inhalation of Placebo once daily for a maximum of 14 days

Locations

Country	Name	City	State
Australia	Investigator site	Darlinghurst
Australia	Investigator site	Westmead
Belgium	Investigator site	Leuven
Spain	Investigator site 1	Valencia
Spain	Investigator site 2	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Ablynx

Countries where clinical trial is conducted

Australia,  Belgium,  Spain, 

Outcome

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