Turner SyndromeNCT06722079
A Real-world Study of Long-acting Growth Hormone Injection for Turner Syndrome
An observational study of Turner Syndrome, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study is divided into two parts: Part A: A multicenter, retrospective, observational study to evaluate the effectiveness of PEG-rhGH in the treatment of Turner syndrome with domestic real-world data on rhGH as external controls. Read more about this study
- Who is it for?
- Ages 0 to 18 years, women only
- Conditions the study is for
- Turner Syndrome
- How many people
- 743 participants
- Where
- 1 siteChina
- Study dates
- 8 Nov 2022to 5 Jun 2023
- Phase
- Observational
- 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 0 to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: The indication in this study is Turner syndrome, which only occurred in females.
Who may be able to join
- Patients diagnosed with Turner syndrome by a clinician;
- The first treatment was short-acting rhGH, and the first administration date was not earlier than July 1, 2008;
- Follow-up data are available at the center before the first dosing and after at least one dosing.
Who cannot join
- ● None.
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji hospital affiliated to tongji medicalcollege of huazhong university of science＆technology
Wuhan, Hubei, 430000
About this study
Official title: A Comparative Study of the Therapeutic Effect of PEGylated Recombinant Human Growth Hormone(PEG-rhGH) Injection on Turner Syndrome in a Clinical Trial and Short-acting Recombinant Human Growth Hormone in a Real World Study
This study is divided into two parts:
Part A: A multicenter, retrospective, observational study to evaluate the effectiveness of PEG-rhGH in the treatment of Turner syndrome with domestic real-world data on rhGH as external controls. The collection and arrangement of real world data is the content of the real world study (RWS); Part B: Meta analysis (MA) was conducted based on the previous literatures on rhGH in the treatment of Turner syndrome, and MA results were used as external controls to evaluate the effectiveness of PEG-rhGH.
Real-world data on rhGH treatment of Turner syndrome in China were obtained from the HIS system and/or paper medical records of participating domestic centers and/or photocopied/printed medical records of other hospitals. Data on the efficacy of PEG-rhGH injection in the treatment of Turner syndrome were obtained from the 0.2mg /kg/ week group in the Phase II clinical trial of PEG-rhGH injection in the treatment of Turner syndrome (multicenter, randomized, blank control, superior efficacy) conducted by Changchun GeneScience Pharmaceutical Co., Ltd (Protocol number: GenSci032-02, version date: April 27, 2015). The MA study data of rhGH in the treatment of Turner syndrome in foreign countries came from the relevant literature retrieved from the approved drug database of FDA, PubMed and Web of Science database.
- Conditions
- Turner Syndrome
- Medical subject headings
- Turner Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PEG-rhGH injection | The group of Turner syndrome patients treated with a dose of 0.2 mg/kg/ week in GenSci032-02 clinical trial. | |
| rhGH injection | Part A control group: a group of Turner syndrome patients treated with rhGH who met the inclusion criteria of the RWS study population from participating research centers in China. Part B control group: studies of rhGH treatment for Turner syndrome performed abroad that met all MA inclusion criteria and did not meet any MA exclusion criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in height standard deviation scores (HT SDS) after 1 year (52 weeks) of treatment compared to before (i.e., baseline) (ΔHT SDS).
Change in height standard deviation scores (HT SDS) after 1 year (52 weeks) of treatment compared to before (i.e., baseline) (ΔHT SDS).
Measured: Week 52
Secondary outcomes (1)
The annualized height velocity (AHV, cm/ year) after 1 year (52 weeks) of treatment.
The annualized height velocity (AHV, cm/ year) after 1 year (52 weeks) of treatment.
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start8 Nov 2022
- Primary completion5 Jun 2023
- Study completion5 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Turner SyndromeStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 743 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tongji Hospital
- Responsible party
- Sponsor
- Investigators
- xiaoping Luo, Doctor, Study chair, Tongji hospital affiliated to tongji medicalcollege of huazhong university of science＆technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722079
- Sponsor's protocol ID
- Gensci032-401
- Status last verified
- Dec 2024
- First submitted
- 3 Dec 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of the Therapeutic Effect of PEGylated Recombinant Human Growth Hormone(PEG-rhGH) Injection on Turner Syndrome in a Clinical Trial and Short-acting Recombinant Human Growth Hormone in a Real World Study
- ClinicalTrials.gov ID
- NCT06722079
- Acronym / sponsor ID
- Gensci032-401
- Conditions
- Turner Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 743 participants (actual)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Tongji Hospital
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 5 Jun 2023 (actual)
- Study completion
- 5 Jun 2023 (actual)
- First posted
- 9 Dec 2024 (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.
This study is divided into two parts:
Part A: A multicenter, retrospective, observational study to evaluate the effectiveness of PEG-rhGH in the treatment of Turner syndrome with domestic real-world data on rhGH as external controls. The collection and arrangement of real world data is the content of the real world study (RWS); Part B: Meta analysis (MA) was conducted based on the previous literatures on rhGH in the treatment of Turner syndrome, and MA results were used as external controls to evaluate the effectiveness of PEG-rhGH.
Real-world data on rhGH treatment of Turner syndrome in China were obtained from the HIS system and/or paper medical records of participating domestic centers and/or photocopied/printed medical records of other hospitals. Data on the efficacy of PEG-rhGH injection in the treatment of Turner syndrome were obtained from the 0.2mg /kg/ week group in the Phase II clinical trial of PEG-rhGH injection in the treatment of Turner syndrome (multicenter, randomized, blank control, superior efficacy) conducted by Changchun GeneScience Pharmaceutical Co., Ltd (Protocol number: GenSci032-02, version date: April 27, 2015). The MA study data of rhGH in the treatment of Turner syndrome in foreign countries came from the relevant literature retrieved from the approved drug database of FDA, PubMed and Web of Science database.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG-rhGH injection | – | –The group of Turner syndrome patients treated with a dose of 0.2 mg/kg/ week in GenSci032-02 clinical trial. |
| rhGH injection | – | –Part A control group: a group of Turner syndrome patients treated with rhGH who met the inclusion criteria of the RWS study population from participating research centers in China. Part B control group: studies of rhGH treatment for Turner syndrome performed abroad that met all MA inclusion criteria and did not meet any MA exclusion criteria. |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The indication in this study is Turner syndrome, which only occurred in females.
Key inclusion criteria (3 listed)
- Patients diagnosed with Turner syndrome by a clinician;
- The first treatment was short-acting rhGH, and the first administration date was not earlier than July 1, 2008;
- Follow-up data are available at the center before the first dosing and after at least one dosing.
Key exclusion criteria (1 listed)
- ● None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in height standard deviation scores (HT SDS) after 1 year (52 weeks) of treatment compared to before (i.e., baseline) (ΔHT SDS).
Time frame: Week 52
Change in height standard deviation scores (HT SDS) after 1 year (52 weeks) of treatment compared to before (i.e., baseline) (ΔHT SDS).
1 secondary outcome
The annualized height velocity (AHV, cm/ year) after 1 year (52 weeks) of treatment.
Time frame: Week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
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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.
xiaoping Luo, Doctor study chair
Tongji hospital affiliated to tongji medicalcollege of huazhong university of science＆technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Turner Syndrome, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 9 Dec 2024. 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 China. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in height standard deviation scores (HT SDS) after 1 year (52 weeks) of treatment compared to before (i.e., baseline) (ΔHT SDS). (time frame: Week 52). 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 9 Dec 2024.