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

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

Conditions: Immunoglobulins

Treatments: Other: NHIg prescription

Study type: Observational

Funder types: Other

Identifiers

NCT06027450

APHP230354

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

250 participants in 1 patient group

Patients treated with NHIg

Description:

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

Treatment:

Other: NHIg prescription