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A Multicentre Study in Otherwise Healthy Infants and Toddlers Hospitalised For and Diagnosed With RSV Lower Respiratory Tract Infection to Evaluate the Safety, Tolerability, and Clinical Activity of ALX-0171

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ClinicalTrials.gov Identifier: NCT02309320
Recruitment Status : Completed
First Posted : December 5, 2014
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Ablynx

Brief Summary:

The primary objective of the study is to investigate the safety and tolerability of ALX-0171.

The secondary objectives are to evaluate the clinical effect of ALX-0171 and to explore the pharmacodynamics (PD) and the systemic pharmacokinetics (PK) of ALX-0171.


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I/IIa Multicentre Study in Otherwise Healthy Infants and Toddlers Hospitalised For and Diagnosed With Respiratory Syncytial Virus Lower Respiratory Tract Infection, Consisting of an Open-label Lead-in Part Followed by a Double-blind, Placebo-controlled Part, to Evaluate the Safety, Tolerability and Clinical Activity of ALX-0171, Administered Via Inhalation, in Addition to Standard of Care.
Actual Study Start Date : December 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Arm Intervention/treatment
Experimental: ALX-0171
Inhalation of ALX-0171 during 3 consecutive days
Biological: ALX-0171
Placebo Comparator: Placebo
Inhalation of Placebo during 3 consecutive days
Other: Placebo



Primary Outcome Measures :
  1. Safety and Tolerability as measured by the incidence of treatment emergent adverse events, clinical laboratory parameters and physical examination [ Time Frame: 1 day before first dose to 14 days after first dose ]

Secondary Outcome Measures :
  1. Clinical activity as measured by the evaluation of the clinical response of the subjects [ Time Frame: 1 day before first dose to 14 days after first dose ]
  2. Exploratory Pharmacokinetics as measured by the concentration of ALX-0171 in serum [ Time Frame: Day 3 ]
  3. Exploratory Pharmacodynamics as measured by the concentration of viral load in respiratory secretions and exploratory biomarkers in serum [ Time Frame: 1 day before first dose to 14 days after first dose ]
  4. Immunogenicity as measured by the concentration of anti-drug antibodies in serum [ Time Frame: 1 day before first dose to 14 days after first dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 23 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is otherwise healthy, but hospitalised for and clinically diagnosed with RSV LRTI (Lower Respiratory Tract Infection)
  2. Subject has appearance of upper or lower respiratory tract infection symptoms that are likely related to RSV
  3. Subject has a positive RSV diagnostic test
  4. Others as defined in the protocol

Exclusion Criteria:

  1. Subject has history of wheezing
  2. Subject is known to have significant comorbidities
  3. Subject is known to be immunocompromised
  4. Subject is suspected of having a clinically relevant infection other than RSV
  5. 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): NCT02309320


  Show 59 Study Locations
Sponsors and Collaborators
Ablynx
Investigators
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Study Director: Ablynx Clinical Department Ablynx

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Responsible Party: Ablynx
ClinicalTrials.gov Identifier: NCT02309320     History of Changes
Other Study ID Numbers: ALX0171-C104
2014-002841-23 ( EudraCT Number )
First Posted: December 5, 2014    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Virus Diseases
Respiratory Tract Infections
Respiratory Syncytial Virus Infections
Respiratory Tract Diseases
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections