A Study to Investigate the Safety and Efficacy of Once-we... | NCT06024967

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

NCT06024967

Sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Status

Unknown status

Last Update Posted

Sep 11, 2023Actual

Enrollment

180Estimated

Phase

Phase 3

Conditions

Interventions

PEG-somatropin

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2023Estimated

Primary Completion Date

May 1, 2025Estimated

Completion Date

Sep 1, 2025Estimated

First Submitted Date

Aug 9, 2023

First Submission Date that Met QC Criteria

Aug 29, 2023

First Posted Date

Sep 6, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 7, 2023

Last Update Posted Date

Sep 11, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GenSci004	Experimental		Drug: PEG-somatropin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PEG-somatropin	Drug	PEG-somatropin	GenSci004

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse Events of once-weekly GenSci004 in children with GHD	Incidents of adverse events	108 weeks

Secondary Outcomes

Measure	Description	Time Frame
Annualized Height Velocity (AHV)	Measured in centimeter per year (cm/year)	104 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Duan Peng	Contact	+86-431-85195060		info@gensci-china.com

Overall Officials

Name	Affiliation	Role
Lawrence Silverman, MD	Morristown Medical Center	Study Chair

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004393	Dwarfism, Pituitary

Ancestor Terms

ID	Term
D004392	Dwarfism
D001848	Bone Diseases, Developmental
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided