Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will take place at multiple sites and is divided into three phases:an initial 4-week getting-to-know-you phase,a 26-week main phase where participants receive medication,and a 4-week follow-up phase.Participants will be divided into three groups:two will receive different doses of PEG-rhGH Injection,and the third will receive hGH Injection.The goal is to determine which medication works best.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG-rhGH dose 1 weekly | Experimental | Jintrolong® dose 1, subcutaneous injection, once every week for 26 weeks. |
|
| PEG-rhGH dose 2 weekly | Experimental | Jintrolong® dose 2, subcutaneous injection, once every week for 26 weeks |
|
| Daily hGH (active control) | Active Comparator | Jintropin® dose 3, subcutaneous injection, once daily for 26 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG-rhGH Injection | Drug | Jintrolong® Dose 1, subcutaneous injection, once weekly for 26 weeks for 24 subjects.. Jintrolong® Dose 2, subcutaneous injection, once weekly for 26 weeks for 24 subjects.. |
| Measure | Description | Time Frame |
|---|---|---|
| Annual height velocity at Week 26 of treatment | 26 Weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiao Ping Luo | Contact | +8613387522645 | xpluo888@sina.com | |
| Ling Hou | Contact | +8613437131846 | houlingtj@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430030 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| hGH Injection | Drug | Jintropin® dose 3, subcutaneous injection, once daily for 26 weeks (active comparator) for 24 subjects. |
|
|
| ID | Term |
|---|---|
| C562190 | polyethylene glycol-recombinant human growth hormone |
Not provided
Not provided
Not provided