Status:
TERMINATED
Phase 2/3 Study to Evaluate PK, Safety & Efficacy of INM004 in STEC Positive Pediatric Patients for Prevention of HUS
Lead Sponsor:
Inmunova S.A.
Collaborating Sponsors:
Exeltis
Conditions:
Bloody Diarrhea
STEC, Unspecified
Eligibility:
All Genders
1-10 years
Phase:
PHASE2
PHASE3
Brief Summary
The investigational medicinal product (IMP), INM004, proposes to neutralize the toxin in the bloodstream to prevent the interaction of the Stx with the specific receptor, by means of a polyclonal anti...
Detailed Description
Hemolytic uremic syndrome (HUS) is a form of thrombotic microangiopathy, characterized by microangiopathic hemolytic anemia, thrombocytopenia, and acute renal impairment of varying severity, which may...
Eligibility Criteria
Inclusion
- Age of ≥ 1 to \< 10 y.
- Signed informed consent from the parent(s)/legal guardian with assent from the subject as appropriate by age and regulatory guidance.
- Bloody diarrhea based upon history or presentation (by visual inspection).
- Detection of Stx2 in stool based on enzyme immunoassay (EIA) and/or stx2 based on PCR before randomization.
- NOTE: The basis for accepting a positive test for stx2 by EIA is based on taking as valid the results yielded from an EIA whose sensitivity and specificity are greater than 98.7% and 100%, respectively (according to the description in the insert) as per recommendation given by the NRL. The Sponsor will select the investigational sites that have in their laboratory such EIA test used in the STEC diagnostic routine algorithm. (Appendix 6).
- For children between 1 to 5 years old: weight for length/height between percentiles 3 (\< 2 z score) and 97 (\> 2 z score) corresponding to age (according to the reference tables "WHO Child Growth Standards".
- For children ≥ 5 years: Body mass index (BMI) between percentiles 3 (\<2 z score) and 97 (\> 2 z score) corresponding to age (according to the reference tables "WHO Child Standards, Appendix 4)
Exclusion
- Any laboratory findings compatible with the development of HUS:
- Microangiopathic hemolytic anemia defined as LDH above the ULN for age with the finding of schistocytes on peripheral smear and a negative Coomb's test, and/or
- Thrombocytopenia: platelet count \< 150 × 103/μL, and/or
- Renal failure: serum creatinine \> ULN adjusted for age and gender criteria despite correction of hypovolemia, and/or hematuria, and/or proteinuria (Table 7.1)11 NOTE: Laboratory results must be obtained within 24 h before the 1st study drug administration; there must be no clinical signs and symptoms of HUS at the time laboratory assessments are obtained. If there is any change in clinical presentation in the 24 h before the 1st study drug administration, laboratory assessments are to be repeated and results reviewed before study drug administration.
- NOTE: Laboratory and physical examination results must indicate normal hydration before the 1st study drug administration.
- A history of chronic/recurrent hemolytic anemia, thrombocytopenia, or chronic renal failure.
- A family history of aHUS.
- Anuria or oliguria after hypovolemia is corrected.
- Evidence of clinically significant chronic active disease not medically controlled.
- History of anaphylaxis, prior administration of equine serum (eg, antitetanus serum or anti-ophidic serum, or anti-arachnid toxin serum), or allergic reaction to contact with, or exposure to, horses.
- Family relation or work relation with a member of the personnel of the research group.
- \-
Key Trial Info
Start Date :
July 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 19 2022
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04132375
Start Date
July 17 2019
End Date
July 19 2022
Last Update
July 19 2023
Active Locations (7)
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1
Hospital Penna
Bahía Blanca, Buenos Aires, Argentina, 8000
2
Hospital Sor Maria Ludovica
La Plata, Buenos Aires, Argentina
3
Hospital Lucio Molas
Santa Rosa, La Pampa Province, Argentina
4
Hospital Castro Rendon
Neuquén, Neuquén Province, Argentina