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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05353192
Other study ID # GenSci001-01
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date September 23, 2022
Est. completion date February 2025

Study information

Verified date February 2023
Source GeneScience Pharmaceuticals Co., Ltd.
Contact Yanru Wu
Phone +86 15843110489
Email wuyanru@gensci-china.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Children with Achondroplasia


Recruitment information / eligibility

Status Recruiting
Enrollment 38
Est. completion date February 2025
Est. primary completion date February 2025
Accepts healthy volunteers No
Gender All
Age group 2 Years to 10 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Recombinant human growth hormone
Recombinant human growth hormone (15IU/5mg/3ml/bottle),0.05 mg/kg/d by subcutaneous injection for 52 weeks

Locations

Country Name City State
China Children's Hospital of Fudan University Shanghai Shanghai

Sponsors (11)

Lead Sponsor Collaborator
GeneScience Pharmaceuticals Co., Ltd. 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, West China Second University Hospital, Sichuan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Change From Baseline in Metabolism-related Proteins Change From Baseline in Serum Proteomics at week 13, week 26, week 52 week 13, week 26, week 52
Primary Change From Baseline in Annualized Height Velocity (AHV) at Week 52 The change in AHV after 52 weeks treatment week 52
Secondary Change From Baseline in AHV Change in AHV at week, week 13, week 26, week 39 week 4, week 13, week 26, week 39
Secondary Change From Baseline in Height Standard Deviation Score (Ht SDS) Change From Baseline in Ht SDS at week 4, week 13, week 26, week 39, week 52 week 4, week 13, week 26, week 39, week 52
Secondary Change From Baseline in BMI Standard Deviation Score (BMI SDS) Change From Baseline in BMI SDS at week 4, week 13, week 26, week 39, week 52 week 4, week 13, week 26, week 39, week 52
Secondary Change From Baseline in Sitting Height/Leg Length ratio Standard Deviation Score (SH/LL SDS) Change From Baseline in SH/LL SDS at week 4, week 13, week 26, week 39, week 52 week 4, week 13, week 26, week 39, week 52
Secondary Change From Baseline in IGF-1 Standard Deviation Score (IGF -1 SDS) Change From Baseline in IGF-1 SDS at week 4, week 13, week 26, week 39, week 52 week 4, week 13, week 26, week 39, week 52
Secondary Change From Baseline in IGF-1/IGFBP-3 ratio Change From Baseline in IGF-1/IGFBP-3 ratio at week 4, week 13, week 26, week 39, week 52 week 4, week 13, week 26, week 39, week 52
Secondary Change From Baseline in Bone Age/Chronological Age ratio (BA/CA) Change From Baseline in BA/CA at week 52 week 52
See also
  Status Clinical Trial Phase
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Completed NCT05659719 - A Study to Learn About Recifercept in Patients With Achondroplasia
Active, not recruiting NCT04554940 - A Clinical Trial to Evaluate Safety of Vosoritide in At-risk Infants With Achondroplasia Phase 2
Completed NCT01435629 - A Survey Collecting Data on Adult Height in Patients With Achondroplasia Treated With Somatropin N/A
Enrolling by invitation NCT06164951 - A Study to Evaluate the Efficacy and Safety of Infigratinib in Children and Adolescents With Achondroplasia Phase 3
Completed NCT01516229 - Special Survey for Long Term Application N/A
Completed NCT03872531 - Lifetime Impact Study for Achondroplasia
Active, not recruiting NCT05598320 - A Clinical Trial to Evaluate Efficacy and Safety of TransCon CNP Compared With Placebo in Children With Achondroplasia Phase 2/Phase 3
Terminated NCT05813314 - Bioequivalence Study to Compare Two Injection Devices for BMN 111 in Healthy Participants Phase 1
Recruiting NCT04265651 - Study of Infigratinib in Children With Achondroplasia Phase 2
Recruiting NCT05603936 - Adaption and Testing of the Quality of Life in Short Stature Youth (QoLISSY) Questionnaire for Parents With Children From 0-4
Completed NCT03780153 - The Norwegian Adult Achondroplasia Study
Active, not recruiting NCT04085523 - A Dose Escalation Trial Evaluating Safety, Efficacy, and Pharmacokinetics of TransCon CNP Administered Once Weekly in Prepubertal Children With Achondroplasia Phase 2
Enrolling by invitation NCT05929807 - A Clinical Trial to Investigate Long-term Safety, Tolerability, and Efficacy of Weekly Subcutaneous Doses With TransCon CNP in Children and Adolescents With Achondroplasia Phase 2/Phase 3
Not yet recruiting NCT06433557 - A Phase 2 Clinical Trial to Evaluate Efficacy, Safety, and Tolerability of Navepegritide in Combination With Lonapegsomatropin in Children With Achondroplasia Phase 2
Completed NCT03875534 - A Multi-center, Longitudinal, Observational Study of Children With Achondroplasia
Terminated NCT03794609 - Observational Study Investigating Clinical & Anthropometric Characteristics of Children With Achondroplasia.
Completed NCT03583697 - A Clinical Trial to Evaluate the Safety and Efficacy of BMN 111 in Infants and Young Children With Achondroplasia Phase 2
Active, not recruiting NCT03989947 - An Extension Study to Evaluate Safety and Efficacy of BMN 111 in Children With Achondroplasia Phase 2
Active, not recruiting NCT05246033 - A Dose Escalation Trial Evaluating Safety, Efficacy, and Pharmacokinetics of Multiple Subcutaneous Doses of TransCon CNP Administered Once Weekly in Children With Achondroplasia Phase 2