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

Tracking Information
First Received Date ^ICMJE	November 29, 2010
Last Updated Date	April 23, 2013
Start Date ^ICMJE	November 2010
Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 15, 2010)	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.
Original Primary Outcome Measures ^ICMJE (submitted: December 1, 2010)	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 STPB infection.
Change History	Complete list of historical versions of study NCT01252199 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 15, 2010)	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 ]
Original Secondary Outcome Measures ^ICMJE (submitted: December 1, 2010)	Efficacy: Comparison of clinical event rates (Hemolytic Uremic Syndrome, Bloody Diarrhea) and associated sequelae between arms and dosage cohorts in children presenting with STPB infection. [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of Chimeric Monoclonal Antibodies to Shiga Toxins 1 and 2
Official Title ^ICMJE	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)
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.
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 ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Shiga Toxin Producing Bacterial Infection
Intervention ^ICMJE	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 Drug: Placebo Placebo administered over 1 hour + standard of care
Study Arm (s)	Experimental: cαStx1/cαStx2 Intervention: Drug: cαStx1/cαStx2 Placebo Comparator: Control Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	45
Completion Date	February 2013
Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Bloody diarrhea (by visual inspection) for no more than 36 hours prior to screening (signature of the informed consent). Detection of Shiga toxin (Stx1 and/or Stx2) in stool Exclusion Criteria: 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. Bloody-diarrhea suspected not to be caused by Shiga Toxin-Producing Bacteria (STPB) but by other organisms or preexisting diseases. Family history of proven or suspected hereditary Hemolytic Uremic Syndrome (HUS) or thrombotic thrombocytopenic purpura (TTP). History of chronic/recurrent hemolytic anemia or thrombocytopenia.
Gender	Both
Ages	6 Months to 18 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Argentina, Chile, Peru

Administrative Information
NCT Number ^ICMJE	NCT01252199
Other Study ID Numbers ^ICMJE	CTP_STX005/STX005EXT
Has Data Monitoring Committee	Yes
Responsible Party	Thallion Pharmaceuticals
Study Sponsor ^ICMJE	Thallion Pharmaceuticals
Collaborators ^ICMJE	LFB Biotechnologies, SAS
Investigators ^ICMJE	Not Provided
Information Provided By	Thallion Pharmaceuticals
Verification Date	April 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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