Safety and Efficacy Study of Eculizumab in Shiga-Toxin Producing Escherichia Coli Hemolytic-Uremic Syndrome (STEC-HUS)

An Open-Label, Multi-Center Trial of Eculizumab in Patients With Shiga-Toxin Producing Escherichia Coli Hemolytic-Uremic Syndrome (STEC-HUS)

Sponsors

Lead Sponsor: Alexion Pharmaceuticals

Source Alexion Pharmaceuticals
Brief Summary

This protocol is designed to collect safety and efficacy data on patients that have been or will be treated with eculizumab for STEC-HUS, in the context of the 2011 STEC-HUS epidemic in Germany.

Overall Status Completed
Start Date July 2011
Completion Date June 2012
Primary Completion Date January 2012
Phase Phase 2/Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Improvement in Systemic TMA & Vital Organ Involvement at 8 weeks of treatment defined as either complete or partial responder based on hematologic normalization/improvement & clinically important improvement in Vital Organs: Brain, Kidney, and Thrombosis 8 weeks
Enrollment 198
Condition
Intervention

Intervention Type: Drug

Intervention Name: Eculizumab (Soliris®)

Description: Eculizumab 300 mg, 600 mg, 900 mg or 1200 mg will be administered intravenously

Eligibility

Criteria:

Inclusion Criteria:

1. Patient must be willing and able to give written informed consent/Assent.

2. Adults, adolescents, or pediatric (≥2 months and ≥5kg) patients

3. Patient has been diagnosed with Escherichia Coli Hemolytic-Uremic Syndrome (STEC-HUS)

Exclusion Criteria:

1. Known complement regulatory mutation or family history of complement regulatory mutation

2. Unresolved systemic meningococcal disease

3. 3. Hypersensitivity to eculizumab, to murine proteins or to one of the excipients

Gender: All

Minimum Age: 2 Months

Maximum Age: N/A

Healthy Volunteers: No

Location
Facility:
| Bielefeld, 33615, Germany
| Bielefeld, 33617, Germany
| Bonn, 53127, Germany
| Bremen, 28177, Germany
| Bremerhaven, 27574, Germany
| Essen, 45147, Germany
| Flensburg, 24939, Germany
| Göttingen, 37075, Germany
| Hamburg, 20246, Germany
| Hamburg, 22291, Germany
| Hamburg, 22359, Germany
| Hannover, 30625, Germany
| Karlsruhe, 76133, Germany
| Köln, 50937, Germany
| Lubeck, 23538, Germany
| Magdeburg, 39120, Germany
| Munchen, 81377, Germany
| Munich, 80804, Germany
| Munster, 48149, Germany
| Oldenburg, 26133, Germany
| Ulm, 89081, Germany
| Wildeshausen, 27793, Germany
Location Countries

Germany

Verification Date

April 2013

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Acronym STEC-HUS
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov