Health Condition 1: E230- Hypopituitarism
Conditions
Interventions
Intervention1: SomatoRelTM: SomatoRelTM (Recombinant human growth hormone manufactured by Reliance Life Sciences Pvt. Ltd)
will be administered subcutaneously for one year.
Control Intervention1: Not
Sponsors
Reliance Life Sciences Pvt Ltd RLS
Eligibility
Inclusion criteria
Inclusion criteria: 1. Pre-pubertal males less than 11 years of age and females less than 12 years of age. 2. Patients with diagnosis of growth failure due to idiopathic growth hormone deficiency confirmed during the screening by a standard GH stimulation test 3. Parents/guardian willing to give informed consent and patient willing to give assent (verbal or written) for the study as defined below: - For children - For children â?¥7 and <12 years, verbal assent must be obtained in the presence of the parents/guardian and should be recorded by the parents/guardian.
Exclusion criteria
Exclusion criteria: 1. Patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure. 2. Patients with active malignancy or intracranial tumor. 3. Patients with closed epiphyses. 4. Patients with Prader-Willi syndrome. 5. Patients with a known hypersensitivity to SomatoRelTM or any of its excipients. 6. Growth retardation attributable to causes other than GHD (e.g. inborn errors of metabolism, primary bone disease, chromosomal disorders, etc.) 7. History of clinically significant diseases, e.g. progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, pulmonary, cardiac, neurologic or cerebral disease that renders the patient incapable of participating in the study. 8. Patient participation in another clinical trial 30 days prior to SomatoRelTM administration. 9. Any other condition which investigator feels would pose a significant hazard to the patient, if SomatoRelTM is administered.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective: To evaluate safety of SomatoRelTM Primary Endpoint: Incidence of treatment emergent adverse events occurring during the studyTimepoint: At each monthly visit till Month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objective(s): To evaluate efficacy of SomatoRelTM Secondary Endpoint(s): ï?· Change in height from baseline to 6 months and 12 months ï?· Change in weight from baseline to 6 months and 12 months ï?· Change in BMI from baseline to 6 months and 12 months ï?· Change in bone age (assessed by X-ray of non-dominant hand & wrist) from baseline to 12 months ï?· Immunogenicity assessment will be carried out at baseline, 3, 6, 9 & 12 months or withdrawal visit.Timepoint: Baseline, 3, 6, 9 & 12 months or withdrawal visit. | — |
Countries
India
Contacts
Public ContactGanesh Bagul
Reliance Life Sciences Pvt. Ltd. (RLS)
Outcome results
None listed