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

Immunoglobulins Clinical Trial

— BUS-IG  

Official title:

Bon USage Des ImmunoGlobulines Humaines Normales (IgHN) : Faisabilité de l'intégration Des critères de la hiérarchisation Lors Des Dispensations d'IgHN - BUS-IG

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06027450
• Other study ID #: APHP230354
• Status: Not yet recruiting
• Start date: September 1, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: August 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Laure Deville, Dr
• Phone: +33142494292
• Email: laure.deville[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Immunoglobulins

Intervention

Other:
• NHIg prescription
Analysis of NHIg prescription

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with clinical and biological information in the medical record	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.	At inclusion
Secondary	Adequacy rate between NHIg indications noted in patients files and ANSM prioritization criteria	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.	At inclusion
Secondary	Number of patients prescribed treatment out of hierarchy	Description of the criteria out of hierarchy, justifying the prescription of NHIg in these 3 authorized indications	At inclusion