Good Use of Normal Human ImmunoGlobulins (NHIg): Feasibility of Integrating the Criteria of Hierarchy During of NHIg Dispensations

NCT ID: NCT06027450

Last Updated: 2023-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-01

Study Completion Date

2023-12-01

Brief Summary

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Supply of Normal Human Immunoglobulins (NHIg) has been in steady tension for almost 15 years in the world. The scarcity of raw material, manufacturing time by industries, and increase consumptions are some of the causes. These phenomena has been accentuated for two years in the context of pandemic.

Faced these difficulties, the french National Medication Security Agency (ANSM) , in collaboration with health professionals and patients associations concerned, established a hierarchy of indications of NHIg to prioritize NHIg for patients without therapeutic alternative (2013 and 2019). Its use is sometimes complex, particularly in the indications where the use of NHIg must combine clinico-biological criteria and/or previous treatment lines.

Detailed Description

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Conditions

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Immunoglobulins

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients treated with NHIg

Patients treated for one of the following indications :

* Thrombopenic Idiopathic Purpura (TIP)
* Chronic Demyelinating Inflammatory Polyradiculoneuritis (CDIP)
* Secondary immune deficiency (SID)

NHIg prescription

Intervention Type OTHER

Analysis of NHIg prescription

Interventions

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NHIg prescription

Analysis of NHIg prescription

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients treated with NHIg for one of the following 3 indications between 01/10/2021 and 31/12/2021: TIP, CDIP and SID.
* Patients 18 years of age and older

Exclusion Criteria

* Patient Objection
* Patients treated with NHIg- for another indication
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Laure Deville, Dr

Role: CONTACT

+33142494292

Jérôme Lambert, Dr

Role: CONTACT

+33142499742

Other Identifiers

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APHP230354

Identifier Type: -

Identifier Source: org_study_id

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