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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorInsel Gruppe AG, University Hospital Bern

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Severe ADAMTS13 deficiency ( ≤ 10% activity) and no ADAMTS 13 inhibitor on two or more occasions at least one month apart

Being a family member of a confirmed or suspected patient

Molecular analysis of ADAMTS13 gene with one or more mutations and/or positive infusion trial (full recovered ADAMTS13 activity after infused fresh frozen plasma (FFP) with a plasma half-life of 2-4 days)

Disqualifiers

None

Trial population

Patients with either confirmed or with suspected hereditary TTP and their family members are eligible for enrollment

Trial design

Design model

Case-only

Time perspective

Other

Treatments tested in this trial

  • Observation

    Other intervention

    No interventions planned: treatment of patients at the discretion of the treating/responsible physician

Treatment groups

450 Participants
are divided into 2 treatment groups
Group A: 11 intervention
Group B: 21 intervention

Trial outcomes

Primary outcomes

1

Clinical presentation and disease course in hereditary TTP

Time frame
every year until death

Secondary outcomes

1

Identification of disease-modifying factors, including genotype-phenotype correlation

Time frame
every year until death
2

Treatment requirements in hereditary TTP patients

Time frame
every year until death
3

Documentation of potential adversary effects of (long-term) plasma treatment

Time frame
every year until death
4

Mortality of hereditary TTP

Time frame
every year until death

Other outcomes

Sponsors and contacts

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Insel Gruppe AG, University Hospital Bern

Lead sponsor

Swiss National Science Foundation

Collaborator

Mach Gaensslen Foundation

Collaborator

Baxalta Innovations GmbH, Wien, Austria

Collaborator