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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06027450
Other study ID # APHP230354
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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