Overview

A Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Children With Achondroplasia

Status:
Not yet recruiting
Trial end date:
2025-02-01
Target enrollment:
0
Participant gender:
All
Summary
To Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Children with Achondroplasia
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GeneScience Pharmaceuticals Co., Ltd.
Collaborators:
Chengdu Women's and Children's Central Hospital
Children's Hospital of Fudan University
Children's Hospital of Nanjing Medical University
Children's Hospital of The Capital Institute of Pediatrics
Jiangxi Province Children's Hospital
Shandong Provincial Hospital
Shanghai Children's Hospital
Shengjing Hospital
Tongji Hospital
Treatments:
Hormones
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)
consentï¼›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