Trial record 8 of 22 for: "atypical hemolytic-uremic syndrome" OR "Hemolytic-Uremic Syndrome"
Open Label Controlled Trial of Eculizumab in Adolescent Patients With Plasma Therapy-Sensitive aHUS
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: February 12, 2009
Last updated: November 5, 2012
Last verified: November 2012
The purpose of this study is to determine whether eculizumab is safe and effective in the treatment of adolescent patients with plasma therapy-sensitive Atypical Hemolytic-Uremic Syndrome (aHUS).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label, Multi-Center Controlled Clinical Trial Of Eculizumab in Adolescent Patients With Plasma Therapy-Sensitive Atypical Hemolytic Uremic Syndrome (AHUS)|
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources: Hemolytic Uremic Syndrome Atypical Hemolytic Uremic SyndromeU.S. FDA Resources
Further study details as provided by Alexion Pharmaceuticals:
Primary Outcome Measures:
- Assess the effect of eculizumab on thrombotic microangiopathy (TMA). [ Time Frame: Through 26 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Additional efficacy endpoints related to manifestations of TMA. [ Time Frame: Through 26 weeks ] [ Designated as safety issue: No ]
- Overall safety and tolerability of eculizumab [ Time Frame: Through 26 weeks ] [ Designated as safety issue: Yes ]
- Pharmacokinetics (PK) and pharmacodynamics (PD) of eculizumab in patients with aHUS. [ Time Frame: Through 26 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2009|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Intravenously administered 900mg once per week for 4 weeks, 1200 mg on week 5 and then 1200mg every 2 weeks thereafter.
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