GHDPhase 3ESCALATENCT06024967
A Study to Investigate the Safety and Efficacy of Once-weekly PEG-somatropin (GenSci004) in Children With Growth Hormone Deficiency
A Phase 3 study testing PEG-somatropin in people with GHD, run by Changchun GeneScience Pharmaceutical Co., Ltd..
Trial 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 more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- GHD
- What is being tested?
- PEG-somatropin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 1 Sep 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Safety and Efficacy of Once-weekly PEG-somatropin (GenSci004) in Children With Growth Hormone Deficiency: An Open-label, Single-arm, Multicenter Phase 3 Study
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.
- Conditions
- GHD
- Being tested
- PEG-somatropin
- Keywords
- GHD, growth hormone deficiency
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-somatropinDrug
PEG-somatropin
| Study group | Role | What they receive |
|---|---|---|
| GenSci004 | Experimental | Not described Receives: Drug: PEG-somatropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events of once-weekly GenSci004 in children with GHD
Incidents of adverse events
Measured: 108 weeks
Secondary outcomes (1)
Annualized Height Velocity (AHV)
Measured in centimeter per year (cm/year)
Measured: 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GHDStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lawrence Silverman, MD, Study chair, Morristown Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024967
- Sponsor's protocol ID
- GenSci004-302
- Acronym
- ESCALATE
- Status last verified
- Sep 2023
- First submitted
- 9 Aug 2023
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Once-weekly PEG-somatropin (GenSci004) in Children With Growth Hormone Deficiency: An Open-label, Single-arm, Multicenter Phase 3 Study
- ClinicalTrials.gov ID
- NCT06024967
- Acronym / sponsor ID
- ESCALATE / GenSci004-302
- Conditions
- GHD
- Keywords
- GHD, growth hormone deficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 6 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GenSci004 | Experimental | Drug: PEG-somatropin |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEG-somatropinPEG-somatropin | Drug | GenSci004 |
Primary outcome
Adverse Events of once-weekly GenSci004 in children with GHD
Time frame: 108 weeks
Incidents of adverse events
1 secondary outcome
Annualized Height Velocity (AHV)
Time frame: 104 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Individual participant dataSharing planned: Yes
Related trials for GHD
RecruitingPhase 3
Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children
Growth Disorders, Growth Failure
RecruitingPhase 3
Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency
Growth Hormone Deficiency (GHD)
RecruitingPhase 3
Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
Adult Growth Hormone Deficiency, Mild Traumatic Brain Injury
Enrolling by invitationObservational study
Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in Patients With Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA)
Growth Hormone Deficiency in Children, Born Small for Gestational Age
Active, not recruitingObservational study
Ngenla Subcutaneous Injection Special Investigation
Growth Hormone Deficiency Without Epiphyseal Closure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence Silverman, MD study chair
Morristown Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PEG-somatropin in people with GHD, run by Changchun GeneScience Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Duan Peng (+86-431-85195060, info@gensci-china.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events of once-weekly GenSci004 in children with GHD (time frame: 108 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.