CTRI/2015/06/005907进行中（未招募）3 期
Prospective, multi-centric, randomized, open-label, two-arm, parallel group, active control, comparative clinical study to evaluate efficacy, safety, pharmacokinetics and pharmacodynamics of R-TPR-007/ Norditropin® Nordilet® in growth hormone deficient children
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
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
入选标准
- •Clinically suspected GH-naïve pre-pubertal children
- •Idiopathic growth hormone deficiency
- •Patients with ratio of bone age/chronological age of <0.9 with open epiphysis.
- •Patients who are euthyroid.
- •Parents willing to give informed consent and subject willing to give assent for the study.
- •Able to comprehend and willing to come for follow up visits as per protocol
- •requirement
排除标准
- •Patients with a history of resistance to growth hormone therapy
- •Patients with any major systemic illness, and/or had known hypersensitivity to study
- •Patients with active neoplasia or intracranial tumor at screening.
- •Growth retardation attributable to causes other than GHD
- •History of Intrauterine growth retardation.
- •Patients with history of administration of other growth-altering medications.
- •Patients with abnormal laboratory parameters
- •Patients who test positive for HIV, HBsAg, or HCV.
- •History of clinically significant diseases.
- •Patient participation in another clinical trial 30 days prior to administration of IP.
- •Any other condition which investigator feels would pose a significant hazard to the
- •patient, if IP is administered.
研究者
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