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

August 30, 2023 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Analysis of NHIg prescription

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with clinical and biological information in the medical record
Time Frame: 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.
At inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adequacy rate between NHIg indications noted in patients files and ANSM prioritization criteria
Time Frame: 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.
At inclusion
Number of patients prescribed treatment out of hierarchy
Time Frame: At inclusion
Description of the criteria out of hierarchy, justifying the prescription of NHIg in these 3 authorized indications
At inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

August 21, 2023

First Submitted That Met QC Criteria

August 30, 2023

First Posted (Actual)

September 7, 2023

Study Record Updates

Last Update Posted (Actual)

September 7, 2023

Last Update Submitted That Met QC Criteria

August 30, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • APHP230354

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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