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Study of Chimeric Monoclonal Antibodies to Shiga Toxins 1 and 2

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ClinicalTrials.gov Identifier: NCT01252199
Recruitment Status : Completed
First Posted : December 2, 2010
Last Update Posted : April 25, 2013
Sponsor:
Collaborator:
LFB Biotechnologies, SAS
Information provided by (Responsible Party):
Thallion Pharmaceuticals

Brief Summary:
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 or disease Intervention/treatment Phase
Shiga Toxin Producing Bacterial Infection Drug: cαStx1/cαStx2 Drug: Placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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)
Study Start Date : November 2010
Primary Completion Date : December 2012
Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]
    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 :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

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): 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

Responsible Party: Thallion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01252199     History of Changes
Other Study ID Numbers: CTP_STX005/STX005EXT
First Posted: December 2, 2010    Key Record Dates
Last Update Posted: April 25, 2013
Last Verified: April 2013

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

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