Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2025-12-30 @ 3:44 AM
Study NCT ID:
NCT05532566
Status:
RECRUITING
Last Update Posted:
2025-05-01
First Post:
2022-09-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quercus Ilex and Quercus Robur Allergen Extracts Standardisation
Sponsor:
Inmunotek S.L.
Organization:
Study Overview
Official Title:
Quercus Ilex and Quercus Robur Allergen Extracts. Determination of the in Vivo Allergenic Potency in Histamine Equivalent Units (HEP).
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to determine the biological activity of Quercus illex and Quercus robur allergen extracts in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).
Detailed Description:
The trial will consist of a single visit, in which the following procedures will be carried out:
* Demographic data.
* Clinical history.
* Inclusion/exclusion criteria.
* General examination.
* Performance of prick-tests (3 concentrations of Quercus ilex allergenic extract, 3 concentrations of Quercus robur allergenic extract, positive control and negative control).
* Obtaining a blood sample from the patient to create a pool of sera for the "in vitro" standardization of the allergenic extract. This pool of sera is necessary for the characterization of the Company's standard. Each serum sample will be stored in a tube that will be labeled with the subject number and frozen. These serum samples will remain in the freezer until the study is completed. When the study is completed, they will be transported to the laboratory, where all sera will be pooled. This "pool" of sera will be used to perform the complementary in vitro standardization tests. These include ELISA for measurement of inhibition against specific IgE, etc. These serum samples are not destroyed. They are pooled together to form a pool that will be used, as described in the previous paragraph, in all the in vitro tests necessary to standardize and characterize this extract and produce its corresponding HIRP (In-house reference preparation), as indicated by the Royal Spanish Pharmacopoeia and the European Pharmacopoeia. This pool of sera is not destroyed, it is used in the in vitro analyses necessary for the standardization of new batches of this allergenic extract. Once the pool has been formed, the tubes containing the original serum samples are destroyed.
* Evaluation of adverse events.
* Demographic data.
* Clinical history.
* Inclusion/exclusion criteria.
* General examination.
* Performance of prick-tests (3 concentrations of Quercus ilex allergenic extract, 3 concentrations of Quercus robur allergenic extract, positive control and negative control).
* Obtaining a blood sample from the patient to create a pool of sera for the "in vitro" standardization of the allergenic extract. This pool of sera is necessary for the characterization of the Company's standard. Each serum sample will be stored in a tube that will be labeled with the subject number and frozen. These serum samples will remain in the freezer until the study is completed. When the study is completed, they will be transported to the laboratory, where all sera will be pooled. This "pool" of sera will be used to perform the complementary in vitro standardization tests. These include ELISA for measurement of inhibition against specific IgE, etc. These serum samples are not destroyed. They are pooled together to form a pool that will be used, as described in the previous paragraph, in all the in vitro tests necessary to standardize and characterize this extract and produce its corresponding HIRP (In-house reference preparation), as indicated by the Royal Spanish Pharmacopoeia and the European Pharmacopoeia. This pool of sera is not destroyed, it is used in the in vitro analyses necessary for the standardization of new batches of this allergenic extract. Once the pool has been formed, the tubes containing the original serum samples are destroyed.
* Evaluation of adverse events.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2020-005388-30 | EUDRACT_NUMBER | None | View |