Actively Recruiting

All Genders
NCT01257269

Genotype and Phenotype Correlation in Hereditary Thrombotic Thrombocytopenic Purpura (Upshaw-Schulman Syndrome)

Led by Insel Gruppe AG, University Hospital Bern · Updated on 2023-10-11

450

Participants Needed

7

Research Sites

1252 weeks

Total Duration

On this page

Sponsors

I

Insel Gruppe AG, University Hospital Bern

Lead Sponsor

S

Swiss National Science Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

Hereditary thrombotic thrombocytopenic purpura (Upshaw-Schulman syndrome) is a rare disorder characterized by thrombocytopenia as a result of platelet consumption, microangiopathic hemolytic anemia, occlusion of the microvasculature with von Willebrand factor-platelet-thrombic and ischemic end organ damage. The underlying patho-mechanism is a severe congenital ADAMTS13 (a disintegrin and metalloproteinase with thrombospondin type 1 motif, 13) deficiency which is the result of compound heterozygous or homozygous ADAMTS13 gene mutations. Although considered a monogenic disorder the clinical presentation in Upshaw-Schulman syndrome patients varies considerably without an apparent genotype-phenotype correlation. In 2006 we have initiated a registry for patients with Upshaw-Schulman syndrome and their family members to identify possible triggers of acute bouts of TTP, to document individual clinical courses and treatment requirements as well as possible side effects of long standing plasma substitution, e.g. alloantibody formation or viral infections.

CONDITIONS

Official Title

Genotype and Phenotype Correlation in Hereditary Thrombotic Thrombocytopenic Purpura (Upshaw-Schulman Syndrome)

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Severe ADAMTS13 deficiency (≤ 10% activity) with no ADAMTS13 inhibitor on two or more occasions at least one month apart
  • Being a family member of a confirmed or suspected patient
  • Molecular analysis showing one or more mutations in the ADAMTS13 gene and/or positive infusion trial with recovery of ADAMTS13 activity after fresh frozen plasma infusion
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 7 locations

1

University of Oklahoma Health Sciences Center, Department of Medicine, PO Box 26901

Oklahoma City, Oklahoma, United States, 73126-0901

Actively Recruiting

2

Medical University of Vienna, Department of Medicine 1, Div. Hematology and Hemostasis Waehringer Guertel 18-20

Vienna, Austria, A-1090

Actively Recruiting

3

Institute of Hematology and Blood Transfusion, Coagulation Laboratory, U nemocnice 1

Prague, Czechia, CZ-12820

Actively Recruiting

4

University Medical Center Hamburg-Eppendorf, Department of Pediatric Hematology and Oncology, Martinistr 52

Hamburg, Germany, D-20246

Not Yet Recruiting

5

Nara Medical University, Department of Blood Transfusion Medicine, Shijyo-cho 840

Kashihara, Nara, Japan, 634-8522

Actively Recruiting

6

Trondheim University St Olavs Hospital, Department of Hematology, PO Box 3250 Sluppen

Trondheim, Norway, NO-7006

Actively Recruiting

7

University Clinic of Hematology and Central Hematology Laboratory, Bern University Hospital and the University of Bern, Inselspital

Bern, Switzerland, 3010

Actively Recruiting

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Research Team

J

Johanna A Kremer Hovinga, MD

CONTACT

M

Marissa Schraner, Ph.D.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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