Site for WUH: A PHASE 3 OPEN-LABEL RANDOMIZED MULTICENTER 12 MONTHS EFFICACY AND SAFETY STUDY OF WEEKLY MOD-4023 COMPARED TO DAILY GENOTROPIN THERAPY IN PRE-PUBERTAL CHILDREN WITH GROWTH HORMONE DEFICIENCY
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Growth Hormone Deficiency
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Age: Between 3 Year(s) - 11 Year(s)
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Gender: Male or Female
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Other Inclusion Criteria:
- Willing and able to provide written informed consent of the parent or legal guardian of the participant and written assent from pediatric participants
- Confirmed diagnosis of GHD by 2 different GH provocation tests
- Bone age is not older than Chronological Age
- Has no prior exposure to any r-hGH therapy
- Impaired Height and Height Velocity
- Children with multiple hormonal deficiencies must be on stable replacement therapies
You may not be eligible for this study if the following are true:
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- Children with prior history of leukemia, lymphoma, sarcoma or any other form of cancer
- History of radiation therapy or chemotherapy
- Malnourished children
- Children with psychosocial dwarfism
- Children born small for gestational age
- Any CS abnormality likely to affect growth or the ability to evaluate growth
- T2 and T1 diabetic patients
- Chromosomal abnormalities
- Concomitant administration of other treatments that may have an effect on growth
- Children requiring glucocorticoid therapy
- Major medical conditions and/or presence of contraindication to r-hGH treatment
- More than 1 closed epiphyses
- Known or suspected HIV-positive patient, or patient with advanced diseases such as AIDS or tuberculosis
- Drug, substance, or alcohol abuse
- Known hypersensitivity to the components of study medication
- Other causes of short stature
- Participant and/or parent/ legal guardian likely to be non-compliant to study conduct
- Participating in another study with investigational agent
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.