ImmunoglobulinsBUS-IGNCT06027450
Good Use of Normal Human ImmunoGlobulins (NHIg): Feasibility of Integrating the Criteria of Hierarchy During of NHIg Dispensations
An observational study of Immunoglobulins, run by Assistance Publique - Hôpitaux de Paris.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Immunoglobulins
- What is being tested?
- NHIg prescription
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Patient Objection
- Patients treated with NHIg- for another indication
Trial locations and contacts
No sites are listed yet.
About this study
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
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
- Being tested
- NHIg prescription
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NHIg prescriptionOther
Analysis of NHIg prescription
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: NHIg prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At inclusion
Secondary outcomes (2)
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.
Measured: At inclusion
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
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunoglobulinsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027450
- Sponsor's protocol ID
- APHP230354
- Acronym
- BUS-IG
- Status last verified
- Aug 2023
- First submitted
- 21 Aug 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06027450
- Acronym / sponsor ID
- BUS-IG / APHP230354
- Conditions
- Immunoglobulins
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 7 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with NHIg | – | Other: NHIg prescriptionPatients treated for one of the following indications : * Thrombopenic Idiopathic Purpura (TIP) * Chronic Demyelinating Inflammatory Polyradiculoneuritis (CDIP) * Secondary immune deficiency (SID) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Patient Objection
- Patients treated with NHIg- for another indication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NHIg prescriptionAnalysis of NHIg prescription | Other | Patients treated with NHIg |
Primary outcome
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.
2 secondary outcomes
Adequacy rate between NHIg indications noted in patients files and ANSM prioritization criteria
Time frame: At inclusion
Number of patients prescribed treatment out of hierarchy
Time frame: At inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Immunoglobulins, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laure Deville, Dr (+33142494292, laure.deville@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with clinical and biological information in the medical record (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.