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Efficacy and Safety of JINTROLONG for Transitional Growth Hormone Deficiency

Efficacy and Safety of JINTROLONG for Transitional Growth Hormone Deficiency (TGHD)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048579
Enrollment
Unknown
Registered
2021-07-11
Start date
2021-08-01
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transitional Growth Hormone Deficiency

Interventions

Experimental group:polyethylene glycol recombinant human growth hormone injection

Sponsors

The Children's Hospital of Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 26 Years

Inclusion criteria

Inclusion criteria: 1. Childhood-onset growth hormone deficiency patients, such as patients with benign brain tumors after surgery, are recommended for >= 1 year after surgery; 2. Bone age: female >= 14.5 years old, male >= 16.5 years old; 3. Actual age: female =1 year; 5. Serum GH peak value in insulin resistance test (ITT) <5ng/ml; 6. When other hormones (such as glucocorticoids, thyroid hormones) are deficient, they should have received other hormone replacement therapy, and the investigator judged that the condition was stable before enrollment; 7. The subject is willing and able to cooperate in completing scheduled visits, treatment plans and laboratory tests,and sign a written informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with abnormal renal function (Cr> the upper limit of normal value); 2. Patients with abnormal liver function caused by hepatotropic virus or other inherited metabolic liver diseases (except for abnormal liver function caused by fatty liver) 3. Those with chronic diseases that affect bone metabolism and body composition for a long time (including but not limited to renal rickets, hypophosphatemic rickets, abnormal parathyroid function or Cushing syndrome, etc.); 4. Diabetic patients; 5. BMI>=28kg/m2; 6. Female patients who are pregnant or breastfeeding, or have a positive baseline pregnancy test; 7. Known to be highly allergic or allergic to the test drugs in this study; 8. Those who have participated in clinical trials of other drugs within 3 months; 9. Other conditions deemed inappropriate by the investigator to be included in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Body composition;

Secondary

MeasureTime frame
Bone mineral density;Waist Circumference;Hip circumference;Body mass index;

Countries

China

Contacts

Public ContactFu Junfen

Children's Hospital of Zhejiang University School of Medicine

fjf68@zju.edu.cn+86 571 8887 3013

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026