A clinical trial to study the effects of two drugs, R-TPR-007 and Norditropin® Nordilet® in growth hormone deficient childre
- Conditions
- Health Condition 1: null- Growth hormone deficiency in children
- Registration Number
- CTRI/2015/06/005907
- Lead Sponsor
- Reliance Life Sciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in height at 6 months and 12 months.Timepoint: 6 months and 12 months from baseline, after start of the therapy
- Secondary Outcome Measures
Name Time Method Mean change in % weight increase at 6 months and 12 months <br/ ><br>Mean change in BMI at 6 months and 12 months <br/ ><br>Mean change in bone age at 12 months <br/ ><br>Change in IGF-1 levels. <br/ ><br>Pharmacokinetic parameters and pharmacodynamics parameter <br/ ><br>Evaluation of safety <br/ ><br>Anti rhGH antibody assessments <br/ ><br>Timepoint: 6 months and 12 months from baseline, after start of the therapy