Study of Chimeric Monoclonal Antibodies to Shiga Toxins 1 and 2

Shiga Toxin Producing Bacterial Infection Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01252199
• Other study ID #: CTP_STX005/STX005EXT
• Status: Completed
• Phase: Phase 2
• First received: November 29, 2010
• Last updated: April 23, 2013
• Start date: November 2010
• Est. completion date: February 2013

Study information

• Verified date: April 2013
• Source: Thallion Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaChile: Instituto de Salud Pública de ChilePeru: Instituto Nacional de SaludUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 18 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Infections
• Shiga Toxin Producing Bacterial Infection

Intervention

Drug:
• caStx1/caStx2
caStx1/caStx2 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
Placebo administered over 1 hour + standard of care

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Thallion Pharmaceuticals	LFB Biotechnologies, SAS

Countries where clinical trial is conducted

Argentina,  Chile,  Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability: Evaluation of number and type of adverse events and serious adverse events between arms and dosage cohorts	Evaluation of the safety and tolerability of two different intravenous dose levels of a combined caStx1/caStx2 preparation in separate groups of children presenting with Shiga Toxin-Producing Bacterial (STPB) infection.	Up to 1 year	Yes
Secondary	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.		Up to 1 year	No