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Completed
NCT05353192
A Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Children With Achondroplasia
Conditions: Achondroplasia
Sex: All
Ages: 2 Years – 10 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 39
Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Location: Children's Hospital of Fudan University Shanghai Shanghai Municipality
Summary
To Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Children with Achondroplasia
Eligibility Criteria
Inclusion Criteria:
* 2-10 years old;
* In Tanner I stage;
* ACH, documented and confirmed by genetic testing;
* Short stature;
* Ambulatory and able to stand or walk without assistance;
* Parent(s) or guardian(s) consent；
* Had never been treated with growth hormone
Exclusion criteria:
* Short stature condition other than ACH;
* Evidence of growth plate closure (proximal tibia, distal femur);
* Had a fracture of the long bones within 6 months prior to screening;
* Planned or expected bone-related surgery;
* Chronic diseases condition that affect bone metabolism and weight;
* Severe intracranial hypertension
Source: ClinicalTrials.gov (NCT05353192). StuddyBuddy aggregates publicly available trial information.
