Health Condition 1: null- Growth hormone deficiency in children
Conditions
Interventions
Intervention1: R-TPR-007: Dose 0.033mg/Kg/day (0.23mg/kg/week), 7 times a week at night Duration 12 months, Route of administration subcutaneous
Control Intervention1: Norditropin® Nordilet®: Dose:
Sponsors
Reliance Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Clinically suspected GH-naïve pre-pubertal children Idiopathic growth hormone deficiency Patients with ratio of bone age/chronological age of 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in height at 6 months and 12 months.Timepoint: 6 months and 12 months from baseline, after start of the therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in % weight increase at 6 months and 12 months Mean change in BMI at 6 months and 12 months Mean change in bone age at 12 months Change in IGF-1 levels. Pharmacokinetic parameters and pharmacodynamics parameter Evaluation of safety Anti rhGH antibody assessments Timepoint: 6 months and 12 months from baseline, after start of the therapy | — |
Countries
India
Contacts
Public ContactDr Jay Madkaikar
Reliance Lifesciences
Outcome results
None listed