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Evaluation of ALX-0171 in Japanese Children Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract 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: NCT03418571
Recruitment Status : Terminated (The Sponsor decided to discontinue ALX-0171 development (due to insufficient evidence of efficacy). As a result, the ALX0171-C203 study was early terminated.)
First Posted : February 1, 2018
Results First Posted : July 15, 2019
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Ablynx

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Sequential Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Respiratory Syncytial Virus Lower Respiratory Tract Infection
Interventions Biological: ALX-0171 1.5 mg/kg
Other: Placebo
Enrollment 15
Recruitment Details

Sixteen subjects were screened for Cohort 1. Of these, 15 subjects were randomized. There was 1 screen failure due to consent withdrawal.

For Cohort 2, 1 subject was screened but considered a screen failure (consent withdrawal).

Consent was obtained from the first subject on 1 March 2018; last subject completed the final visit on 19 October 2018

Pre-assignment Details All randomized subjects received at least 1 administration of study drug and were included in the Safety Population.
Arm/Group Title ALX-0171 1.5 mg/kg Placebo
Hide Arm/Group Description Single inhalation of ALX-0171 1.5 mg/kg once daily for 3 consecutive days. Single inhalation of placebo once daily for 3 consecutive days.
Period Title: Overall Study
Started 12 3
Completed 11 3
Not Completed 1 0
Reason Not Completed
Consent withdrawn by legal guardian             1             0
Arm/Group Title ALX-0171 1.5 mg/kg Placebo Total
Hide Arm/Group Description Single inhalation of ALX-0171 1.5 mg/kg once daily for 3 consecutive days. Single inhalation of placebo once daily for 3 consecutive days. Total of all reporting groups
Overall Number of Baseline Participants 12 3 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 12 participants 3 participants 15 participants
7.4  (4.65) 3.5  (3.04) 6.6  (4.58)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 3 participants 15 participants
Female
5
  41.7%
2
  66.7%
7
  46.7%
Male
7
  58.3%
1
  33.3%
8
  53.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 3 participants 15 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
12
 100.0%
3
 100.0%
15
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Safety and Tolerability of Inhaled ALX-0171 1.5 mg/kg as Measured by the Number of Subjects With at Least 1 Serious or Non-Serious Treatment-emergent Adverse Event (TEAE).
Hide Description Number of subjects reported with at least 1 serious or non-serious TEAEs in the ALX-0171 1.5 mg/kg treatment group and placebo treatment group.
Time Frame From the subject's first study drug administration until completion of the subject's last visit, an average of 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title ALX-0171 1.5 mg/kg Placebo
Hide Arm/Group Description:
Single inhalation of ALX-0171 1.5 mg/kg once daily for 3 consecutive days.
Single inhalation of placebo once daily for 3 consecutive days.
Overall Number of Participants Analyzed 12 3
Measure Type: Number
Unit of Measure: participants
At least one serious TEAE 1 0
At least one non-serious TEAE 8 1
2.Primary Outcome
Title Safety and Tolerability of Inhaled ALX-0171 1.5 mg/kg as Measured by the Number of Serious and Non-serious TEAEs.
Hide Description Number of serious and non-serious TEAEs reported in the ALX-0171 1.5 mg/kg treatment group and placebo treatment group.
Time Frame From the subject's first study drug administration until completion of the subject's last visit, an average of 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title ALX-0171 1.5 mg/kg Placebo
Hide Arm/Group Description:
Single inhalation of ALX-0171 1.5 mg/kg once daily for 3 consecutive days.
Single inhalation of placebo once daily for 3 consecutive days.
Overall Number of Participants Analyzed 12 3
Measure Type: Number
Unit of Measure: TEAE
Serious TEAE 2 0
Non-Serious TEAE 18 1
Time Frame From the subject's first study drug administration until the subject's study completion/discontinuation date, an average of 4 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ALX-0171 1.5 mg/kg Placebo
Hide Arm/Group Description Single inhalation of ALX-0171 1.5 mg/kg once daily for 3 consecutive days. Single inhalation of placebo once daily for 3 consecutive days.
All-Cause Mortality
ALX-0171 1.5 mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)      0/3 (0.00%)    
Hide Serious Adverse Events
ALX-0171 1.5 mg/kg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/12 (8.33%)      0/3 (0.00%)    
Infections and infestations     
Pneumonia hemophilus  1  1/12 (8.33%)  1 0/3 (0.00%)  0
Pneumonia bacterial  1  1/12 (8.33%)  1 0/3 (0.00%)  0
1
Term from vocabulary, MedDRA (21.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ALX-0171 1.5 mg/kg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/12 (66.67%)      1/3 (33.33%)    
Blood and lymphatic system disorders     
Iron deficiency anemia  1  1/12 (8.33%)  1 0/3 (0.00%)  0
Ear and labyrinth disorders     
Middle ear effusion  1  1/12 (8.33%)  1 0/3 (0.00%)  0
Gastrointestinal disorders     
Diarrhoea  1  1/12 (8.33%)  1 0/3 (0.00%)  0
Gastric ulcer  1  1/12 (8.33%)  1 0/3 (0.00%)  0
General disorders     
Edema  1  1/12 (8.33%)  1 0/3 (0.00%)  0
Hepatobiliary disorders     
Hepatic function abnormal  1  0/12 (0.00%)  0 1/3 (33.33%)  1
Infections and infestations     
Upper respiratory tract infection  1  2/12 (16.67%)  2 0/3 (0.00%)  0
Otitis media  1  1/12 (8.33%)  1 0/3 (0.00%)  0
Otitis media acute  1  1/12 (8.33%)  1 0/3 (0.00%)  0
Pneumonia bacterial  1  1/12 (8.33%)  1 0/3 (0.00%)  0
Nervous system disorders     
Myoclonus  1  1/12 (8.33%)  1 0/3 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Upper respiratory tract inflammation  1  1/12 (8.33%)  1 0/3 (0.00%)  0
Skin and subcutaneous tissue disorders     
Miliaria  1  3/12 (25.00%)  3 0/3 (0.00%)  0
Dermatitis contact  1  1/12 (8.33%)  1 0/3 (0.00%)  0
Dermatitis diaper  1  1/12 (8.33%)  1 0/3 (0.00%)  0
Erythema  1  1/12 (8.33%)  1 0/3 (0.00%)  0
1
Term from vocabulary, MedDRA (21.1)
Indicates events were collected by systematic assessment
Based on the results of the Phase IIb study ALX0171-C201 (RESPIRE), the Sponsor decided to discontinue ALX-0171 development in infants and to early terminate the ALX0171-C203 study. Therefore, no data are available for the higher dose groups.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Publication of any results from this study will be according to the principles of the Declaration of Helsinki, in particular point 30, and will require prior review and written agreement of the Sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Monitor
Organization: Ablynx NV
Phone: +32 9 262 00 00
EMail: clinicaltrials@ablynx.com
Layout table for additonal information
Responsible Party: Ablynx
ClinicalTrials.gov Identifier: NCT03418571    
Other Study ID Numbers: ALX0171-C203
First Submitted: January 26, 2018
First Posted: February 1, 2018
Results First Submitted: May 2, 2019
Results First Posted: July 15, 2019
Last Update Posted: July 30, 2019