Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03468829
Recruitment Status : Withdrawn (ALX-0171 development program was stopped)
First Posted : March 19, 2018
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
Ablynx

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.


Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus Lower Respiratory Tract Infection Biological: ALX-0171 Dose 1 Biological: ALX-0171 Dose 2 Biological: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Arm Intervention/treatment
Experimental: ALX-0171 Dose 1 Biological: ALX-0171 Dose 1
Oral inhalation of ALX-0171 Dose 1 once daily for a maximum of 14 days

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

Placebo Comparator: Placebo Biological: Placebo
Oral inhalation of Placebo once daily for a maximum of 14 days




Primary Outcome Measures :
  1. Time-weighted average change from baseline in log10 RSV nasal viral load [ Time Frame: From Day 1 to Day 7 ]

Secondary Outcome Measures :
  1. Safety as measured by the incidence of treatment-emergent (serious) adverse events [ Time Frame: From Screening to Day 42 ]
  2. Nasal RSV load parameter: time to undetectable shedding [ Time Frame: From Day 1 to Day 42 ]
  3. Clinical stabilization (defined as respiratory rate <25/minute and stable oxygen saturation >92% on room air for at least 12 hours) [ Time Frame: From Day 1 to Day 42 ]
  4. Number of days without oxygen or with oxygen supplementation [ Time Frame: From Day 1 to Day 42 ]
  5. Progression to lower respiratory tract (LRT) disease in subjects presenting with upper respiratory tract infection (URTI) at baseline [ Time Frame: From Day 1 to Day 42 ]
  6. Concentration of ALX-0171 in serum [ Time Frame: Day 1 to Day 14 ]
    Measurement of ALX-0171 serum concentration at different time points from baseline until Day 14.

  7. Immunogenicity as measured by the concentration of anti-ALX 0171 antibodies in serum [ Time Frame: From Day 1 to Day 42 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03468829


Locations
Layout table for location information
Australia
Investigator site
Darlinghurst, Australia
Investigator site
Westmead, Australia
Belgium
Investigator site
Leuven, Belgium
Spain
Investigator site 1
Valencia, Spain
Investigator site 2
Valencia, Spain
Sponsors and Collaborators
Ablynx
Investigators
Layout table for investigator information
Study Director: Ablynx Clinical Department Ablynx

Layout table for additonal information
Responsible Party: Ablynx
ClinicalTrials.gov Identifier: NCT03468829     History of Changes
Other Study ID Numbers: ALX0171-C204
2017-003356-23 ( EudraCT Number )
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases