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

Not yet recruiting

• Conditions: Immunoglobulins
• Interventions: Other: NHIg prescription

• Registration Number: NCT06027450
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-21
• Study First Submitted QC: 2023-08-30
• Last Update Submitted: 2023-08-30
• Study Start: 2023-09-01
• Study First Posted: 2023-09-07
• Last Update Posted: 2023-09-07
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 250

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

Read More

Exclusion Criteria

• Patient Objection
• Patients treated with NHIg- for another indication

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients treated with NHIg	NHIg prescription	Patients treated for one of the following indications : * Thrombopenic Idiopathic Purpura (TIP) * Chronic Demyelinating Inflammatory Polyradiculoneuritis (CDIP) * Secondary immune deficiency (SID)

Primary Outcome Measures

Name	Time	Method
Number of patients with clinical and biological information in the medical record	At inclusion	* For TIP: Khellaf score present dating from less than a week; * For CDIP: mention of at least one plasmapheresis since diagnosis and before NHIg prescription; * For SID: mention of recent repeated infections (at least 2 infections that lead to hospitalization in the year before starting treatment) and rate of IgG dating from less than 3 months.

Secondary Outcome Measures

Name	Time	Method
Adequacy rate between NHIg indications noted in patients files and ANSM prioritization criteria	At inclusion	* For TIP: Ig prescription if Khellaf score \>8 dating from less than a week.; * For CDIP: Ig prescription if plasmapheresis was executed in first intention; * For SID: prescription of Ig if recent repeated infections (at least 2 infections that lead to hospitalization in the year before starting treatment) and rate of IgG dating from less than 3 months.
Number of patients prescribed treatment out of hierarchy	At inclusion	Description of the criteria out of hierarchy, justifying the prescription of NHIg in these 3 authorized indications