EUCTR2006-002278-24-CZ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.
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) yes
- •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) Evidence of growth of pituitary adenoma or other intracranial tumor within the last 12 months, or patients without MRI or CT data to confirm the tumor stability within the last 12 months. (footnote: An additional MRI or CT scan will be conducted to confirm the tumor stability if a patient meets other inclusion and exclusion criteria, but DOES NOT have MRI or CT date within last 12 months to confirm th etumor stbility.)
- •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
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