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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00593229
Other study ID # DK71221
Secondary ID DK R21-71221
Status Terminated
Phase N/A
First received January 2, 2008
Last updated June 18, 2013
Start date January 2007

Study information

Verified date June 2013
Source Northwell Health
Contact n/a
Is FDA regulated No
Health authority United States: Federal GovernmentUnited States: Institutional Review Board
Study type Observational

Clinical Trial Summary

This registry will collect clinical data and store biosamples (seru, plasma, urine, and DNA) annually from pediatric patients with thrombotic mcroangiopathy


Description:

Children age, 6 months - 18 years, are eligible if they have one of the following categories of thrombotic microangiopathy (TMA):(1) severe D+HUS; (2) non-familial atypical HUS; (3) familial atypical HUS; or (4) TTP

Patients are seen intially and annually thereafter

Biosamples are collected for storage annually.


Recruitment information / eligibility

Status Terminated
Enrollment 6
Est. completion date
Est. primary completion date October 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Months to 18 Years
Eligibility Inclusion Criteria:

- Severe HUS, familial or non-familial atypical HUS, TTP

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Schneider Chldren's Hospital New Hyde Park New York

Sponsors (9)

Lead Sponsor Collaborator
Northwell Health Children's Hospital of Philadelphia, Icahn School of Medicine at Mount Sinai, Mario Negri Institute for Pharmacological Research, Montreal Children's Hospital of the MUHC, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Stollery Children's Hospital, University of Utah, University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Determine epidemiology and outcomes of the various forms of TMA Ongoing No
Primary Determine genetic causes of TMA Ongoing No
Secondary Initiate clinical trials in TMA In the future Yes
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