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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002691-17 | EudraCT Number |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eculizumab (Soliris®) | Drug | Eculizumab 300 mg, 600 mg, 900 mg or 1200 mg will be administered intravenously |
| Measure | Description | 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 | Analysis of primary endpoint will occur after all patients have reached 8 weeks of treatment. The response rate will be summarized as patients who are either a complete or partial responder. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bielefeld | 33615 | Germany | ||||
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| Bielefeld |
| 33617 |
| Germany |
| Bonn | 53127 | Germany |
| Bremen | 28177 | Germany |
| Bremerhaven | 27574 | Germany |
| Cologne | 50937 | Germany |
| Essen | 45147 | Germany |
| Flensburg | 24939 | Germany |
| Göttingen | 37075 | Germany |
| Hamburg | 20246 | Germany |
| Hamburg | 22291 | Germany |
| Hamburg | 22359 | Germany |
| Hanover | 30625 | Germany |
| Karlsruhe | 76133 | Germany |
| Lübeck | 23538 | Germany |
| Magdeburg | 39120 | Germany |
| Munich | 80804 | Germany |
| München | 81377 | Germany |
| Münster | 48149 | Germany |
| Oldenburg | 26133 | Germany |
| Ulm | 89081 | Germany |
| Wildeshausen | 27793 | Germany |
| ID | Term |
|---|---|
| C481642 | eculizumab |
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