GHDPhase 3ELEVATENCT06007417
A Study to Investigate Efficacy and Safety of Weekly PEG-somatropin (GenSci004) in Treatment Naive Children With Growth Hormone Deficiency
A Phase 3 study testing GenSci004 and Genotropin in people with GHD, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of weekly GenSci004 compared with daily Genotropin in treatment-naive children with growth failure due to GHD. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- GHD
- What is being tested?
- GenSci004 and Genotropin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2023to 1 Aug 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Prepubertal children with GHD in Tanner Stage 1
- Baseline HT at least -2.0 SD below the mean HT for CA and sex (HT SDS ≤ 2.0).
- Body mass index (BMI) within ±2.0 SD of the mean BMI for BA and sex.
- Growth hormone stimulation tests: ≤10 ng/mL
- Baseline IGF 1 level of at least 1.0 SD below the mean IGF 1 level standardized for age and sex (IGF 1 SDS ≤-1.0)
- Normal 46 XX karyotype for girls.
- Children with multiple hormonal deficiencies must be on stable replacement therapy for other hypothalamo-pituitary axes for at least 3 months
- Written, signed informed consent of the parent(s) or legal guardian(s) of the participant and written assent of the participant
Who cannot join
- BA≥CA
- Prior exposure to rhGH, long-acting growth hormones, or IGF 1 therapy.
- Major medical conditions or presence of contraindication to human growth hormone (hGH) treatment
- Participation in any other trial of an investigational agent within 3 months prior to Screening.
- Any reason per investigator's discretion
Trial locations and contacts
1 site in 1 country.
United States1 site
Cook Childrens
Fort Worth, Texas, 76104
Maria Gomez
Paul Thornton, MD
About this study
Official title: The Efficacy and Safety of Once-weekly PEG-somatropin (GenSci004) in Treatment-naive Children With Growth Hormone Deficiency: A Randomized, Open-label, Parallel-group, Active-Controlled, Non-inferiority Phase 3 Study (ELEVATE)
The purpose of this study is to evaluate the efficacy and safety of weekly GenSci004 compared with daily Genotropin in treatment-naive children with growth failure due to GHD.
Read the detailed description
The purpose of this Phase 3 study is to evaluate the efficacy, safety, and tolerability of weekly GenSci004 compared to daily Genotropin over 52 weeks in prepubertal treatment-naïve children with growth failure due to GHD.
- Conditions
- GHD
- Being tested
- GenSci004, Genotropin
- 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.
GenSci004Drug
GenSci004 is a pegylated rhGH (PEG rhGH) (i.e., PEG-somatropin)
GenotropinDrug
Genotropin
| Study group | Role | What they receive |
|---|---|---|
| GenSci004 | Experimental | Not described Receives: Drug: GenSci004 |
| Genotropin | Active comparator | Not described Receives: Drug: Genotropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized Height Velocity (AHV) for GenSci004 and Genotropin groups
Measured in centimeter per year (cm/year)
Measured: 52 weeks
Secondary outcomes (1)
Annualized Height Velocity (AHV) for GenSci004 and Genotropin groups
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 posted23 Aug 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Aug 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bradley Miller, Study chair, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06007417
- Sponsor's protocol ID
- GenSci004-301
- Acronym
- ELEVATE
- 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
- No
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 Efficacy and Safety of Once-weekly PEG-somatropin (GenSci004) in Treatment-naive Children With Growth Hormone Deficiency: A Randomized, Open-label, Parallel-group, Active-Controlled, Non-inferiority Phase 3 Study (ELEVATE)
- ClinicalTrials.gov ID
- NCT06007417
- Acronym / sponsor ID
- ELEVATE / GenSci004-301
- Conditions
- GHD
- Keywords
- GHD, growth hormone deficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 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 Aug 2025 (estimated)
- First posted
- 23 Aug 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 study is to evaluate the efficacy and safety of weekly GenSci004 compared with daily Genotropin in treatment-naive children with growth failure due to GHD.
Detailed description
The purpose of this Phase 3 study is to evaluate the efficacy, safety, and tolerability of weekly GenSci004 compared to daily Genotropin over 52 weeks in prepubertal treatment-naïve children with growth failure due to GHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GenSci004 | Experimental | Drug: GenSci004 |
| Genotropin | Active comparator | Drug: Genotropin |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Prepubertal children with GHD in Tanner Stage 1
- Baseline HT at least -2.0 SD below the mean HT for CA and sex (HT SDS ≤ 2.0).
- Body mass index (BMI) within ±2.0 SD of the mean BMI for BA and sex.
- Growth hormone stimulation tests: ≤10 ng/mL
- Baseline IGF 1 level of at least 1.0 SD below the mean IGF 1 level standardized for age and sex (IGF 1 SDS ≤-1.0)
Key exclusion criteria (5 listed)
- BA≥CA
- Prior exposure to rhGH, long-acting growth hormones, or IGF 1 therapy.
- Major medical conditions or presence of contraindication to human growth hormone (hGH) treatment
- Participation in any other trial of an investigational agent within 3 months prior to Screening.
- Any reason per investigator's discretion
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 |
|---|---|---|
| GenSci004GenSci004 is a pegylated rhGH (PEG rhGH) (i.e., PEG-somatropin) | Drug | GenSci004 |
| GenotropinGenotropin | Drug | Genotropin |
Primary outcome
Annualized Height Velocity (AHV) for GenSci004 and Genotropin groups
Time frame: 52 weeks
Measured in centimeter per year (cm/year)
1 secondary outcome
Annualized Height Velocity (AHV) for GenSci004 and Genotropin groups
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: No
Related trials for GHD
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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.
Bradley Miller study chair
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GenSci004 and Genotropin in people with GHD, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in United States.
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 8 inclusion and 5 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.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Peng Duan (+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?
Annualized Height Velocity (AHV) for GenSci004 and Genotropin groups (time frame: 52 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.