Efficacy of INM004 in Children With STEC-HUS
ConditionHemolytic-Uremic Syndrome
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age9-17
SponsorInmunova S.A.
About this trial
The objectives of this study are to evaluate the efficacy, safety, and pharmacokinetics of INM004 in pediatric patients with Hemolytic Uremic Syndrome associated to infection by Shiga toxin-producing Escherichia coli (STEC-HUS).
Eligibility criteria
Qualifiers
Age ≥ 9 months and < 18 years at the time of randomization.
Detection of generic Stx, Stx1, Stx2, or Stx1/Stx2 in stools by enzyme immunoassay (EIA); or
Detection of stx, stx1, stx2, or stx1/stx2 genes in stools by Polymerase Chain Reaction (PCR); or
Detection of specific anti-polysaccharide (IgM) antibodies in serum; or
Disqualifiers
Start of dialysis within 48 hours prior to admission to the participating institution.
More than 24 hours from diagnosis of STEC-HUS at the participating institution up to randomization.
History of chronic/recurrent hemolytic anemia, thrombocytopenia, or CKD.
Personal and/or family history of atypical HUS.
Trial design
Treatments tested in this trial
- INM004
- Placebo
Treatment groups
220 Participants
are divided into 2 treatment groupsSponsors and collaborators
Inmunova S.A.
Lead sponsor
Exeltis
Collaborator
Chemo Research
Collaborator
Linical
Collaborator
KLIXAR
Collaborator
Source ClinicalTrials.gov