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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01342146
Other study ID # GenSci-004 CT
Secondary ID
Status Completed
Phase Phase 2
First received April 21, 2011
Last updated July 27, 2017
Start date May 2006
Est. completion date February 2007

Study information

Verified date May 2011
Source GeneScience Pharmaceuticals Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the multicenter, randomized, open-label, controlled phase II study is to determine whether pegylated recombinant human growth hormone is effective in the treatment of children with growth hormone deficiency.


Recruitment information / eligibility

Status Completed
Enrollment 101
Est. completion date February 2007
Est. primary completion date January 2007
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- have a height less than two standard deviations (SD) below the median height for individuals of the same age or height, a growth velocity (GV) =4 cm/yr, a GH peak concentration <7 ng/ml in two different provocative tests, a bone age (BA; =9 years in girls and =10 years in boys) at least 2 years less than his/her chronological age (CA);

- be in preadolescence (Tanner stage 1) and have a CA >3 years;

- have a height value recorded 3 months before the start of GH treatment to calculate pre-treatment GV;

- receive no prior GH treatment.

- sign informed consent

Exclusion Criteria:

- patients with severe cardiopulmonary

- patients with hematological diseases

- a current or past history of malignant tumors

- immunodeficiency diseases

- mental diseases

- patients positive for hepatitis B e-antibody (HBeAb)

- hepatitis B surface antigen (HBsAg)

- hepatitis B e antigen (HBeAg)

- patients with other growth disorders, such as Turner syndrome

- constitutional delay of growth and puberty, and Laron syndrome

Study Design


Intervention

Drug:
pegylated Somatropin
0.1 mg/kg/wk once a week for 25 weeks
pegylated Somatropin
0.2 mg/kg/wk once a week for 25 weeks
Jintropin AQ
0.25 mg/kg/wk, once a day for 25 weeks

Locations

Country Name City State
n/a

Sponsors (5)

Lead Sponsor Collaborator
GeneScience Pharmaceuticals Co., Ltd. Capital Medical University, Children's Hospital of Fudan University, First Affiliated Hospital, Sun Yat-Sen University, Huazhong University of Science and Technology

References & Publications (1)

Luo X, Hou L, Liang L, Dong G, Shen S, Zhao Z, Gong CX, Li Y, Du ML, Su Z, Du H, Yan C. Long-acting PEGylated recombinant human growth hormone (Jintrolong) for children with growth hormone deficiency: phase II and phase III multicenter, randomized studies — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Growth velocity 25 weeks
Secondary height standard deviation score for chronological age (Ht SDSCA) 25 weeks
Secondary IGF-1 25 weeks
Secondary IGFBP3 25 weeks
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