EUCTR2006-002278-24-IT进行中（未招募）不适用
A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. - BPLG-005-RO
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
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
- •1)Patients (male and female) who have completed the Visit 8 of preceding main study (BPLG-005) and are willing to continue their participation in an extension study.
- •2)If female, women of child-bearing potential who are using a reliable method of contraception and be willing to use it throughout the study. A negative urine pregnancy test at Visit 0 is required for females of child-bearing potential.
- •3)Written informed consent of the patient.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •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
- •1)Evidence of active malignancy or growth of a previously stable tumor.
- •2)Benign intracranial hypertension.
- •3)Clinically significant respiratory, cardiac, hepatic, renal, neuromuscular disease.
- •4)Non-compliance with medications, un-cooperativeness or drug abuse during the BPLG-005 study.
- •5)Patients who are not able to comply with the study protocol for any reason.
研究者
相似试验
进行中（未招募）
不适用
A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.Growth hormone deficiency in adultsMedDRA version: 8.1Level: LLTClassification code 10056438Term: Growth hormone deficiencyEUCTR2006-002278-24-SEBioPartners GmbH150
进行中（未招募）
不适用
A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.Growth hormone deficiency in adultsMedDRA version: 8.1Level: LLTClassification code 10056438Term: Growth hormone deficiencyEUCTR2006-002278-24-CZBioPartners GmbH150
进行中（未招募）
不适用
A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.EUCTR2006-002278-24-ATG Life Sciences Ltd.150
进行中（未招募）
1 期
A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.Growth hormone deficiency in adultsMedDRA version: 8.1 Level: LLT Classification code 10056438 Term: Growth hormone deficiencyEUCTR2006-002278-24-GBBioPartners GmbH150
进行中（未招募）
不适用
A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.Growth hormone deficiency in adultsMedDRA version: 8.1Level: LLTClassification code 10056438Term: Growth hormone deficiencyEUCTR2006-002278-24-FRBioPartners GmbH150