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NCT03123497 Clinical Trial

Assessment of Quality of Life of Children With Chronic Idiopathic Thrombocytopenic Purpura (Kid's ITP Tools)

Idiopathic Thrombocytopenic Purpura Clinical Trial

— KIT  

Official title:
Assessment of Quality of Life of Children With Chronic Idiopathic Thrombocytopenic Purpura

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03123497
Other study ID # 49RC17_0011
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 12, 2017
Est. completion date October 30, 2020

Study information
Verified date March 2020
Source University Hospital, Angers
Contact marianne roumy
Phone 0241356385
Email marianne.roumy@chu-angers.fr
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Assessment of quality of life of patient with chronic idiopathic thrombocytopenic purpura according to the type of treatment

Recruitment information / eligibility
Status Recruiting
Enrollment 183
Est. completion date October 30, 2020
Est. primary completion date October 2020
Accepts healthy volunteers No
Gender All
Age group 1 Year to 17 Years
Eligibility Inclusion Criteria:

- children with Idiopathic thrombocytopenic purpura

- aged between 1 and 17 year

- Idiopathic thrombocytopenic purpura persistent at 12 months

- obtention of informed consent

Exclusion Criteria:

- Persistant/acute Idiopathic thrombocytopenic purpura

- concomittant chronic disease, stabilized or not

- Concomittant disease with life expectancy < 1 year

- Person who have not belong to a social security scheme

- Secondary Idiopathic thrombocytopenic purpura

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• completion of questionnaire
completion of questionnaire for patient and parent

Locations
Country Name City State
France CHU d'Angers Angers

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary quality of life score according to type of treatment quality of life score according to type of treatment at inclusion visit
Secondary number of hospitalisation and consults per year number of hospitalisation and consults per year at inclusion visit
Secondary description of general quality of life use ped'sQL general at inclusion visit
Secondary description of general quality of life use ped'sQL fatigue at inclusion visit
Secondary description of awareness of parent and patient about Idiopathic thrombocytopenic purpura use Kid's ITO Tools questionnaire at inclusion visit
See also
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Completed NCT00475423 - A Study of MabThera (Rituximab) in Patients With Idiopathic Thrombocytopenic Purpura. Phase 2
Completed NCT00454857 - Retrospective & Prospective Observational Study of Patients With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) N/A
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Terminated NCT01433978 - A Phase 3, Multicenter, Randomized, Double-blind,Active-controlled, Parallel-group Trial With an Open-labelExtension Phase to Evaluate the Efficacy and Safety of OralE5501 Versus Eltrombopag, in Adults With Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) Phase 3
Withdrawn NCT01443351 - Long-term Safety Study of Treatment With the Thrombopoietin Agonists Eltrombopag and Romiplostim in Patients With Immune Thrombocytopenia (ITP)
Completed NCT01520909 - Study of a New Medication for Childhood Chronic Immune Thrombocytopenia (ITP), a Blood Disorder of Low Platelet Counts That Can Lead to Bruising Easily, Bleeding Gums, and/or Bleeding Inside the Body. Phase 3