NCT06024967

Brief Summary

The purpose of this Phase 3 study is to evaluate the safety and efficacy of once-weekly GenSci004 over 108 weeks in children with GHD aged from 6 months to 17 years old, inclusive.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

September 6, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

September 11, 2023

Status Verified

September 1, 2023

Enrollment Period

1.4 years

First QC Date

August 9, 2023

Last Update Submit

September 7, 2023

Conditions

GHD

Keywords

GHDgrowth hormone deficiency

Outcome Measures

Primary Outcomes (1)

  • Adverse Events of once-weekly GenSci004 in children with GHD

    Incidents of adverse events

    108 weeks

Secondary Outcomes (1)

  • Annualized Height Velocity (AHV)

    104 weeks

Study Arms (1)

GenSci004

EXPERIMENTAL
Drug: PEG-somatropin

Interventions

PEG-somatropinDRUG

PEG-somatropin

GenSci004

Eligibility Criteria

Age6 Months - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Investigator-determined diagnosis of GHD prior to the historical initiation of daily rhGH trerapy
  • Participant must be 6 months to 17 years old
  • Tanner stage \<5 at Visit 1
  • Open epiphyses
  • Normal fundoscopy at Screening
  • Written, signed, informed consent of the participant's parent(s)/LAR(s) and written assent of the participant

You may not qualify if:

  • History or presence of malignant disease
  • Children with diabetes mellitus
  • Major medical conditions and/or presence of contraindications to GH treatment
  • Pregnancy
  • Participation in any other study of an investigational agent within three months prior to Visit 1
  • Prior exposure to investigational drug or any other long-acting growth hormone
  • Any other reason per investigator's discretion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dwarfism, Pituitary

Condition Hierarchy (Ancestors)

DwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesBone Diseases, EndocrineHypopituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Study Officials

  • Lawrence Silverman, MD

    Morristown Medical Center

    STUDY CHAIR

Central Study Contacts

Duan Peng

CONTACT

+86-431-85195060info@gensci-china.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2023

First Posted

September 6, 2023

Study Start

December 1, 2023

Primary Completion

May 1, 2025

Study Completion

September 1, 2025

Last Updated

September 11, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share