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

NCT06027450 | Unknown

• 1 other identifier: APHP230354
• Study Type: observational
• Target: 250
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Immunoglobulins

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Adequacy rate between NHIg indications noted in patients files and ANSM prioritization criteria

  At inclusion

• Number of patients prescribed treatment out of hierarchy

  At inclusion

Study Arms (1)

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)

Other: NHIg prescription

Interventions

NHIg prescription OTHER

Analysis of NHIg prescription

Patients treated with NHIg

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Central Study Contacts

Laure Deville, Dr

CONTACT

+33142494292; laure.deville@aphp.fr

Jérôme Lambert, Dr

CONTACT

+33142499742; jerome.lambert@u-paris.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: September 7, 2023
• Study Start: September 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 7, 2023

Record last verified: 2023-08