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Trial · Interventional

CompletedPhase 4Registry data

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

NCTNCT05353192 (opens ClinicalTrials.gov in a new tab)Other idGenSci001-01
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
39 participants (actual)
Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

China

Start
20 Aug 2022
Primary completion
25 Aug 2025
Completion
12 Dec 2025
First posted
29 Apr 2022
Last update posted
6 Aug 2026
Conditions
Achondroplasia

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20222023202420252026
  1. Ph 4

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

    NCT05353192

    20 Aug 2022 to 12 Dec 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • Recombinant human growth hormoneDrug

Arms1

  • Experimental

    Recombinant human growth hormone

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change From Baseline in Annualized Height Velocity (AHV) at Week 52

    Time frame · week 52

    Registry description

    The change in AHV after 52 weeks treatment

Secondary outcomes(7)

  1. Change From Baseline in AHV

    Time frame · week 4, week 13, week 26, week 39

    Registry description

    Change in AHV at week, week 13, week 26, week 39

  2. Change From Baseline in Height Standard Deviation Score (Ht SDS)

    Time frame · week 4, week 13, week 26, week 39, week 52

    Registry description

    Change From Baseline in Ht SDS at week 4, week 13, week 26, week 39, week 52

  3. Change From Baseline in BMI Standard Deviation Score (BMI SDS)

    Time frame · week 4, week 13, week 26, week 39, week 52

    Registry description

    Change From Baseline in BMI SDS at week 4, week 13, week 26, week 39, week 52

  4. Change From Baseline in Sitting Height/Leg Length ratio Standard Deviation Score (SH/LL SDS)

    Time frame · week 4, week 13, week 26, week 39, week 52

    Registry description

    Change From Baseline in SH/LL SDS at week 4, week 13, week 26, week 39, week 52

  5. Change From Baseline in IGF-1 Standard Deviation Score (IGF -1 SDS)

    Time frame · week 4, week 13, week 26, week 39, week 52

    Registry description

    Change From Baseline in IGF-1 SDS at week 4, week 13, week 26, week 39, week 52

  6. Change From Baseline in IGF-1/IGFBP-3 ratio

    Time frame · week 4, week 13, week 26, week 39, week 52

    Registry description

    Change From Baseline in IGF-1/IGFBP-3 ratio at week 4, week 13, week 26, week 39, week 52

  7. Change From Baseline in Bone Age/Chronological Age ratio (BA/CA)

    Time frame · week 52

    Registry description

    Change From Baseline in BA/CA at week 52

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 2 Years up to 10 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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