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Screening method for diagnosing growth hormone deficiency in pediatric patients by using maxirelin

A growth hormone deficiency, growth hormone technology, applied in scientific instruments, biological testing, biomaterial analysis, etc., can solve the problems of time-consuming, resource-consuming, and high burden related to pediatric endocrinologists

Pending Publication Date: 2022-03-29
AETERNA ZENTARIS GMBH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition to this safety topic, it should be noted that conducting two trials is time- and resource-intensive and the associated burden on children and their parents and on the pediatric endocrinologist is high

Method used

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  • Screening method for diagnosing growth hormone deficiency in pediatric patients by using maxirelin
  • Screening method for diagnosing growth hormone deficiency in pediatric patients by using maxirelin
  • Screening method for diagnosing growth hormone deficiency in pediatric patients by using maxirelin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0149] Example 1: Composition for diagnosing CGHD

[0150] Compositions containing Miururin include the following ingredients listed in Table 1.

[0151] Table 1: Table of dose of per unit

[0152] combination Unit quantity Percentage Maethilin (content = 100%) 63.6mg 3.5％ Lactose monohydrate, spray dry 1691.8mg 93.1％ Integerne, type A 36.3mg 2.0％ Colloid silica 1.8mg 0.1％ Stealacanol 18.2mg 1.0％ Sugar sodium, dihydrate 5.5mg 0.3％ total 1817.2mg 100.0％

[0153] A muxirin unit dose consists of 1817.2 mg of a composition for preparing an oral suspension in water. Typically, the prepared suspension contains 0.5 mg of Mi River / ML suspension.

[0154] Substrate-regulated alternate regions were applied to pediatric subjects to give a dose of 1.0 mg / kg. It should be noted that in an adult, a weight-regulated alternating mix suspension is applied, and the weight of the dose of 0.5 mg / kg adult subject is obtained.

[0155] The...

Embodiment 2

[0159] Example 2 : Use of saccharin masked a bad taste in a composition containing the moxilin

[0160] In multi-center, random, two-way, cross-study, 100 subjects with confirmed adult growth hormone deficiency (AGHD) were accepted as GHRH + L-Arg as GHST to determine Mi Ruilin. Diagnostic effect on AGHD.

[0161] This study was carried out in two parts. In the first portion, the composition of the Mahaurrendolin described in Example 1 was used, and the dose was 0.5 mg / kg, but there was no use of saccharide, and 12 (21%) of 52 subjects were reported. Mild to moderate bad taste.

[0162] During the study stop, it was found that saccharin was a suitable mask, although the bitterness was still not completely masked. In the second part of the study, a composition (containing saccharin) described in Example 1 was used, and only 1 (2%) of (2%) in 48 test subjects was reported to the slight intensity.

Embodiment 3

[0163] Example 3: Pharmacokinetics, pharmacodynamics, pharmacodynamics, pharmacodynamics, and exploratory test characteristics as diagnostic trials

[0164]The AEZS-130-P01 is an open mark, group comparison, dose increasing test, to study a single oral oral administration of 0.25 mg / kg, 0.5 mg / kg and 1 mg / kg, mg / kg and 1 mg / kg of Mahauri in a pediatric patient with suspected GHD Safety, Tolerance, Pharmacokinetics (PK) and Pharmacodynamics (PD).

[0165] The target is defined as follows:

[0166] main target:

[0167] · After the introduction of a single oral dose of Methi River, the safety and tolerance of Maeth Ririnlarid after incrementing a single oral dose in a suspected GHD patient patient.

[0168] Secondary goals:

[0169] · In order to study PK, a PK, aptamer, a patient with suspected GHD,

[0170] · In order to study the PD, the PD, which is measuring the measuring hormone (GH) in patients with suspected GHD,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,...

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Abstract

The present invention relates to a screening method for diagnosing growth hormone deficiency in pediatric patients by using maxirelin. The present invention further provides the substance maxirelin for use in the diagnosis of growth hormone deficiency in pediatric patients. The method includes providing at least one blood sample collected from a subject within a range of about 15 to about 100 minutes after administration of maxirelin in an amount effective to induce secretion of growth hormone, measuring a growth hormone level for each blood sample, comparing the measured growth hormone levels to a single threshold, and determining whether the measured growth hormone levels are different from the single threshold. And diagnosing whether the subject has growth hormone deficiency based on a comparison of the growth hormone level in the at least one blood sample to the single threshold. The method of the invention is a stand-alone test, does not require repetition, and does not require additional growth hormone stimulation tests for reliable diagnosis of pediatric patients.

Description

[0001] Inventory background [0002] Growth hormone (GH) is the main body-wide metabolite hormone, which regulates proteins, lipids and carbohydrates, and is necessary for physical and mental growth, developmental and maintenance. GH was produced under the pituitary gland leaf under the growth hormone release hormone (GHRH) stimulation of the hyphenolatene gland. GH is secreted from the pituitary bodies in the 24-hour period. [0003] According to the source of GH deficiency, growth hormone deficiency (GHD) can be roughly divided into four categories: 1) pituitary or "classic" GHD, 2) hypotacoidacteroid GHD, 3) functionality GHD and 4) GHD. GHD may become obvious in the clinic in children or adults. In USA, it is estimated that the incidence of children GHD is between 4,000 and 10,000. In USA, more than 50,000 adults have GHD, which reports, 6,000 new cases each year, including GHD children who transformed into GHD adults (WWW.HGFOUND.org). [0004] GHD is a childhood disease, which...

Claims

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Application Information

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IPC IPC(8): G01N33/74
CPCG01N33/74G01N2333/61G01N33/5091
Inventor N·艾莫M·特伊菲尔B·奥伊
Owner AETERNA ZENTARIS GMBH
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