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A prospective, multicenter clinical study evaluating the efficacy and safety of PEGylated recombinant human growth hormone combined with triptorelin in the treatment of adolescent growth hormone deficiency

A prospective, multicenter clinical study evaluating the efficacy and safety of PEGylated recombinant human growth hormone combined with triptorelin in the treatment of adolescent growth hormone deficiency

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064385
Enrollment
Unknown
Registered
2022-10-05
Start date
2022-10-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Adolescent growth hormone deficiency

Interventions

Intervention group:PEGylated recombinant human growth hormone, administered once a week, in combination with triptorelin, once every 28 days
Control group:PEGylated recombinant human growth hormone, administered once a week

Sponsors

Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Conditions for the diagnosis of growth hormone deficiency: (1) Height 4 mL. 3. The bone age of girls is less than or equal to 12 years old, and the bone age of boys is less than or equal to 14 years old. 4. No recombinant human growth hormone therapy within 3 months.

Exclusion criteria

Exclusion criteria: 1. IGF-1 level > 3SD; 2. Chromosomal abnormality or any significant concomitant disease that may interfere with growth or research; 3. Patients with contraindications to recombinant human growth hormone or GnRHa therapy; 4. Concomitant deficiency of at least one other pituitary hormone.

Design outcomes

Primary

MeasureTime frame
Predict adult height;

Secondary

MeasureTime frame
Height velocity;Height standard deviation scores;Bone age;IGF-1 standard deviation scores;

Countries

China

Contacts

Public ContactLiyang Liang

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

liangliy@mail.sysu.edu.cn+86 13688891219

Outcome results

None listed

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