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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 5
- 主要终点
- Mean change in height at 6 months and 12 months.
研究概览
简要总结
This is a 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. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
The primary outcome will assess the mean change in height at 6 months and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 3.00 Year(s) 至 11.00 Year(s)（—）
- 性别
- All
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 drug 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.
结局指标
主要结局
Mean change in height at 6 months and 12 months.
时间窗: 6 months and 12 months from baseline, after start of the therapy
次要结局
- Mean change in % weight increase at 6 months and 12 months(Mean change in BMI at 6 months and 12 months)
研究者
研究点 (5)
Loading locations...
相似试验
进行中（未招募）
3 期
A clinical trial to study the effects of two drugs, R-TPR-023 and Avastinâ„¢ in patients with Metastatic colorectal cancerCTRI/2013/05/003699Reliance Life sciences Pvt Ltd105
未知
3 期
A clinical trial to study the effects of two drugs, Fixed dose combination of tablets of Rosuvastatin 5 mg and Fenofibrate 160mg with Rosuvastatin 5mg alone in patients with dyslipidemiaDyslipidemiaCTRI/2010/091/000147M/s. Ravenbhel Healthcare Pvt. Ltd.200
招募中
3 期
A clinical trial to study the effects of Agomelatine oral tablets in patients with Major Depressive DisorderMajor Depressive DisorderCTRI/2011/08/001946Precise Chemipharma Pvt Ltd200
已完成
2 期
Testing the efficacy and safety of a blood product COVID-19 Hyper-Immuneglobulin (Human) Solution in Participants with Active COVID-19CTRI/2020/09/027903Intas Pharmaceuticals Limited60
已完成
4 期
Clinical Study of Treating Type 2 Diabetic Nephropathy With Alfacalcidol and IrbesartanType 2 Diabetic NephropathyNCT03147677The Third Xiangya Hospital of Central South University60