EUCTR2015-001681-25-Outside-EU/EEA进行中（未招募）不适用
An Open, Multicenter, Randomized, Controlled Trial to Evaluate the Correlation Between Spontaneous Catch-up Growth, Clinical Response to Saizen (Recombinant Human Growth Hormone, r-hGH) and Gene Expression Profiling in Children Small for Gestational Age (SGA)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Merck KGaA
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- SGA at birth (defined as a length at birth equal or below the tenth percentile according to the Italian reference table of Bertini and Fabris)
- •- Age of 24 Months
- •- Caucasic
- •- Born at term (i.e. after the 37th completed week of gestation)
- •- Height equal or below (Group A) or up (Group B) the third percentile at the age of 24 months according to the Tanner reference table
- •- Sufficient GH secretion (more than 10 nanogram (ng)/milliliter (ml)) at least to one of the tests commonly used at that age (glucagon, Levo-dopa, arginine, clonidine, Growth Hormone Releasing Hormone (GHRH), GH integrated secretion)
- •- Normal level of Thyroid-stimulating hormone (THS), Free Triiodothyronine (FT3), Free Thyroxine (FT4), Insulin-like growth factor 1(IGF-1), insulin and haemoglobin A1c (HbA1c)
- •- Normal level of Immunoglobulin A (IgA)
- •- Children parents willing to comply with the protocol for the whole duration of the study
- •- A written Informed Consent before the baseline visit must be obtained from the parent(s) / legal guardian(s)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 25
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Congenital malformations (including Silver-Russel syndrome)
- •- Known abnormal karyotype, especially in girls
- •- Severe psychomotor retardation
- •- Previous or ongoing treatment with anabolic steroids or r-hGH
- •- Treatments interfering with the immune system (including bacterial lysate)
- •- Severe chronic illnesses
- •- Autoimmune diseases
研究者
相似试验
招募中
不适用
Trial to Compare the Efficacy of elástic bandage 3M Coban™ 2 Lite against the Unna Boot in Patients with Leg UlcersRBR-3y78y4Escola de Enfermagem da Universidade Federal de MInas Gerais
招募中
4 期
A multicenter, randomized, open, controlled trial for the efficacy and safety of Shen-Qi Fu-Zheng injection in the treatment of novel coronavirus pneumonia (COVID-19)ovel Coronavirus Pneumonia (COVID-19)ITMCTR2000003004nion Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
尚未招募
1 期
A Multicenter, Randomized and Controlled Trial for Chang-An-Jun-Tai Granule in the Treatment of Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D).Irritable bowel syndromeITMCTR1900002644The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
进行中（未招募）
1 期
Multicenter, open, pragmatic, randomized trial comparing the efficacy of 3 different lifestyle interventions after addition of sitagliptin to patients with type 2 diabetes mellitus who have inadequate glycemic control on metformin therapy - ADdition of Januvia Improves Glycemic control in patients inadequately controlled by MetformiPatients with T2DM already treated with metformin.MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusEUCTR2007-000755-33-FRaboratoires Merck Sharp & Dohme - Chibret2,500
进行中（未招募）
不适用
on-randomised, open, multi-center trial evaluating feasibility and safety of TachoSil application on a colorectal anastomosis. - Evaluation of TachoSil application on a colorectal anastomosis.EUCTR2007-007254-62-DEycomed Danmark ApS30