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Study of Chimeric Monoclonal Antibodies to Shiga Toxins 1 and 2

This study has been completed.
Sponsor:
Collaborator:
LFB Biotechnologies, SAS
Information provided by (Responsible Party):
Thallion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01252199
First received: November 29, 2010
Last updated: April 23, 2013
Last verified: April 2013
History of Changes
  Purpose

This study is designed to evaluate the safety and efficacy of cαStx1 and cαStx2 administered concomitantly in children presenting early signs of Shiga Toxin-Producing Bacterial (STPB) Infection.


Condition Intervention Phase
Shiga Toxin Producing Bacterial Infection
 Drug: cαStx1/cαStx2
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II Study of Chimeric Monoclonal Antibodies to Shiga Toxins 1 (cαStx1) and 2 (cαStx2) Administered Concomitantly to Children With Shiga Toxin-Producing Bacterial (STPB) Infection and Bloody Diarrhea (SHIGATEC Trial)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Thallion Pharmaceuticals:

Primary Outcome Measures:
  • Safety and Tolerability: Evaluation of number and type of adverse events and serious adverse events between arms and dosage cohorts [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]
    Evaluation of the safety and tolerability of two different intravenous dose levels of a combined cαStx1/cαStx2 preparation in separate groups of children presenting with Shiga Toxin-Producing Bacterial (STPB) infection.


Secondary Outcome Measures:
  • Efficacy: Comparison of clinical event rates (Hemolytic Uremic Syndrome, Bloody Diarrhea) and associated sequelae between arms and dosage cohorts in children presenting with Shiga Toxin-Producing Bacterial (STPB) infection. [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: November 2010
Study Completion Date: February 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cαStx1/cαStx2 Drug: cαStx1/cαStx2
cαStx1/cαStx2 administered concomitantly at a dose of 1 mg/kg (low dose cohort) or 3 mg/kg (high dose cohort)per antibody over 1 hour + standard of care
Placebo Comparator: Control Drug: Placebo
Placebo administered over 1 hour + standard of care

Detailed Description:

Currently, there is no etiological treatment of STPB-induced HUS. Ideally, such treatment would be started in the early phase of the infection and would protect against both types of toxins and all of their variants. The chimeric anti-Shiga toxins 1 (cαStx1) and 2 (cαStx2) antibodies are intended to be administered as a single infusion and provide simultaneous protection against the two Shiga toxins (Stx1 and Stx2) by decreasing the incidence and severity of Shiga toxin-mediated clinical events including bloody diarrhea/hemorrhagic colitis and Hemolytic Uremic Syndrome (HUS) and associated sequelae.

  Eligibility

Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Bloody diarrhea (by visual inspection) for no more than 36 hours prior to screening (signature of the informed consent).
  2. Detection of Shiga toxin (Stx1 and/or Stx2) in stool

Exclusion Criteria:

  1. Laboratory findings compatible with development of at least two out of three following criteria that define Hemolytic Uremic Syndrome (HUS):

    Hemolytic Anemia: hematocrit < 30% with evidence of hemolysis (as indicated by Lactate Dehydrogenase (LDH) above the upper limit of normal for age or the finding of schistocytes on peripheral smear); Thrombocytopenia: platelet count <150 x 103/uL; Nephropathy: serum creatinine > Upper Limit Normal (ULN) adjusted for age and gender.

  2. Bloody-diarrhea suspected not to be caused by Shiga Toxin-Producing Bacteria (STPB) but by other organisms or preexisting diseases.
  3. Family history of proven or suspected hereditary Hemolytic Uremic Syndrome (HUS) or thrombotic thrombocytopenic purpura (TTP).
  4. History of chronic/recurrent hemolytic anemia or thrombocytopenia.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01252199

Locations
Argentina
Bahia Blanca, Argentina
Buenos Aires, Argentina
Cordoba, Argentina
La Plata, Argentina
Mendoza, Argentina
Parana, Argentina
Tucuman, Argentina
Chile
Concepcion, Chile
Santiago, Chile
Valparaiso, Chile
Peru
Lima, Peru
Sponsors and Collaborators
Thallion Pharmaceuticals
LFB Biotechnologies, SAS
  More Information

No publications provided

Responsible Party: Thallion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01252199     History of Changes
Other Study ID Numbers: CTP_STX005/STX005EXT
Study First Received: November 29, 2010
Last Updated: April 23, 2013
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Chile: Instituto de Salud Publica de Chile
Peru: Instituto Nacional de Salud
United States: Food and Drug Administration

Keywords provided by Thallion Pharmaceuticals:
Shigamabs
Monoclonal
Antibodies
Shiga
Toxin
 E.coli
HUS
Bloody
Diarrhea

Additional relevant MeSH terms:
Bacterial Infections
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Shiga Toxins
Immunologic Factors
 Physiological Effects of Drugs
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013