NCT03123497

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
183

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

April 12, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 21, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
Last Updated

March 12, 2020

Status Verified

March 1, 2020

Enrollment Period

3.5 years

First QC Date

April 12, 2017

Last Update Submit

March 11, 2020

Conditions

Keywords

Idiopathic Thrombocytopenic Purpura

Outcome Measures

Primary Outcomes (1)

  • quality of life score according to type of treatment

    quality of life score according to type of treatment

    at inclusion visit

Secondary Outcomes (4)

  • number of hospitalisation and consults per year

    at inclusion visit

  • description of general quality of life

    at inclusion visit

  • description of general quality of life

    at inclusion visit

  • description of awareness of parent and patient about Idiopathic thrombocytopenic purpura

    at inclusion visit

Study Arms (1)

Idiopathic Thrombocytopenic Purpura

completion of questionnaire

Other: completion of questionnaire

Interventions

completion of questionnaire for patient and parent

Idiopathic Thrombocytopenic Purpura

Eligibility Criteria

Age1 Year - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children with idiopathic thombocytopenic purpura, aged between 1 and 17 year

You may qualify if:

  • children with Idiopathic thrombocytopenic purpura
  • aged between 1 and 17 year
  • Idiopathic thrombocytopenic purpura persistent at 12 months
  • obtention of informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU d'Angers

Angers, 49933, France

RECRUITING

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, ThrombocytopenicPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombotic MicroangiopathiesThrombocytopeniaBlood Platelet DisordersCytopeniaHemorrhagic DisordersAutoimmune DiseasesImmune System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Study Officials

  • Isabelle Pellier, Pr

    chu

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2017

First Posted

April 21, 2017

Study Start

April 12, 2017

Primary Completion

October 1, 2020

Study Completion

October 30, 2020

Last Updated

March 12, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations