CClinicalTrials.gg
Sign In
Not yet recruitingNCT06024967ESCALATEUpdated Sep 11, 2023

A Study to Investigate the Safety and Efficacy of Once-weekly PEG-somatropin (GenSci004) in Children With Growth Hormone Deficiency

A Phase 3 interventional study of PEG-somatropin in GHD, sponsored by Changchun GeneScience Pharmaceutical Co., Ltd.. Not yet recruiting. Open to participants aged 6 Months to 17 Years. Per ClinicalTrials.gov, last updated 2023-09-11.

Sponsored by Changchun GeneScience Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 3
Study type
Interventional
Enrollment
180
Allocation
Not applicable
Ages
6 Months to 17 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • GHD

Keywords

  • GHD
  • growth hormone deficiency
03

In context

Lead sponsor

Changchun GeneScience Pharmaceutical Co., Ltd. is the lead sponsor of 108 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. History or presence of malignant disease
  2. Children with diabetes mellitus
  3. Major medical conditions and/or presence of contraindications to GH treatment
  4. Pregnancy
  5. Participation in any other study of an investigational agent within three months prior to Visit 1
  6. Prior exposure to investigational drug or any other long-acting growth hormone
  7. Any other reason per investigator's discretion
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    GenSci004

    Drug: PEG-somatropin

Interventions

  • DrugPEG-somatropin

    PEG-somatropin

06

What researchers measure

Primary outcomes

  1. Adverse Events of once-weekly GenSci004 in children with GHD

    Incidents of adverse events

    Time frame: 108 weeks

Secondary outcomes

  1. Annualized Height Velocity (AHV)

    Measured in centimeter per year (cm/year)

    Time frame: 104 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06024967
Lead sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Sep 6, 2023
Start date
Dec 1, 2023 (estimated)
Primary completion
May 1, 2025 (estimated)
Completion
Sep 1, 2025 (estimated)
Last update
Sep 11, 2023

Study contacts

Duan Peng
Contact
info@gensci-china.com
+86-431-85195060
Lawrence Silverman, MD
study chair · Morristown Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Start the discussion