PER-061-04已完成未知
PHASE II / III, OPEN AND MULTICENTRIC CLINICAL TRIAL TO EVALUATE THE SAFETY AND EFFECTIVENESS OF FACTOR I SIMILAR GROWTH TO INSULIN / PROTEIN 3 OF UNION TO FACTOR I OF GROWTH SIMILAR TO INSULIN (RHIGF-I / RHIGFBP-3 ) ADMINISTERED FOR 12 MONTHS TO CHILDREN AND ADOLESCENTS WITH SYNDROME OF INSENSIBILITY TO GROWTH HORMONE (GHIS) LIKE LARON SYNDROME
试验速览
- 阶段
- 未知
- 状态
- 已完成
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •Diagnosis of a GHIS, such as Laron syndrome, la. If it is necessary to confirm the diagnosis (the main investigators can request it), a test of generation of IGF-I will be completed and the insufficiency of the GH will be demonstrated to invoke the IGF-L
- •2-18 years old,
- •Size less than or equal to-3DE for age,
- •Baseline level of IGF-I less than or equal to -2DE for age,
- •Maximum level of> 29.2 mu / L (> 13.3 pg / L) of growth hormone using a GH challenge test,
- •Prepubertal, defined as the mammary stage of Tanner 1 or testicular volume <4 mL,
- •Baseline level of IGFBP-3 less than or equal to -IDE for the normative age,
- •Evaluation of the documented speed of the previous period of 12 months, and
- •With capacity and willingness to give informed consent or assent.
排除标准
- •Children at puberty, with a bone age of> 12 years for girls and> 14 years for boys,
- •Diagnosis of malignancy,
- •Diabetes mellitus diagnosis,
- •Treatment with rhIGF-I interrupted in the 3 years prior to patient selection for this study,
- •Treatment with growth hormone interrupted less than 6 months before the patient´s recruitment,
- •Treatment with an experimental drug within 30 days prior to selection,
- •Neuropathy, nephropathy, retinopathy or other clinically significant microvascular or macrovascular disease,
- •AST or ALT greater than or equal to 2 times the normal reference interval,
- •serum creatinine above 150 mmol / L (1.70 mg / dl),
- •Previous treatment with GnRH analogues or chronic systemic use of corticosteroids, and
- •Any other condition or treatment that, in the opinion of the investigator, may pose a risk to the patient or interfere with the patient´s ability to comply with this protocol.
研究者
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