Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat SGA Children With Short Stature

Patrocinadores

Patrocinador principal: GeneScience Pharmaceuticals Co., Ltd.

Colaborador: Shanxi Provincial Maternity and Children's Hospital
Children's Hospital of Fudan University
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
First Hospital of Jilin University
Hunan Children's Hospital

Fuente GeneScience Pharmaceuticals Co., Ltd.
Resumen breve

The study was evaluated as the optimal dose for the treatment of SGA short stature children by Pegylated Somatropin, initially evaluated its efficiency and safety for the treatment of SGA short stature children and provided scientific, reliable basis for phase III clinical trials for dose selection.

Descripción detallada

This was a multicenter, randomized phase II study, half of participants will receive the high dose, while the other half will receive the low dose.

Estado general Unknown status
Fecha de inicio October 2014
Fecha de Terminación December 2017
Fecha de finalización primaria July 2017
Fase Phase 2
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Actual height of the patient after treatment compared with the mean height of the population and the standard deviation (SD) of the height of the population for that chronological age. 52 weeks
Resultado secundario
Medida Periodo de tiempo
Height 52 weeks
Bone maturity (bone age change / actual age change: △BA/△CA) 52 weeks
The mole ratio of IGF-1/IGFBP-3: ([IGF-1(ng/ml)/7.6]/[IGFBP-3 (ng/ml)/25.75]) 52 weeks
Inscripción 96
Condición
Intervención

Tipo de intervención: Biological

Nombre de intervención: PEG-somatropin

Elegibilidad

Criterios:

Inclusion Criteria:

- The patients are diagnosed as being clinically full term small for gestational age infant.

- Girl are 3-6 years old, boys are 3-7 years old.

- Be in preadolescence (Tanner stage 1).

- The child did not achieve catch-up growth when he/she entered the group (the definition of catch-up growth is that the height is higher the third percentile with the same age and gender) (Appendix 2 and 3).

- The height of child is shorter than -2SDS of the median of normal children with the same age and gender when he/she entered the group (the mean height and height standard deviation of normal children with the same age and gender of normal children regard the height data in the physical development investigation data of children aged 0-18 in 9 cities of China (2005) as standard [13], Appendix 4 and 5).

- Within a year before entering the group, after any growth hormone stimulation test, the peak concentration of growth hormone in serum>10 µg/L.

- Bone age≤ the actual age+1.

- The function of glucose regulation is normal: fasting blood glucose < 5.6mmol/L.

- Birth gestational age ≥ 37 weeks.

- The subjects and their guardians sign the informed consent (if the subjects is lack of ability for signing the informed consent, his legal guardian can write the subjects name instead).

Exclusion Criteria:

- People with abnormal liver or kidney function (ALT> 2 times the upper limit of normal value, Cr> the upper limit of normal value).

- Patients are positive for hepatitis B core antigen (HBc), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg).

- People with known highly allergic constitution or allergy to the drug or the excipient of the study.

- People with diabetes, severe cardiopulmonary, hematological system and malignant tumors diseases or general infection, immune deficiency and patients with mental disease.

- Other abnormal growth and development, such as Turner syndrome, Laron syndrome, growth hormone receptor deficiency.

- Potential tumor patients (family history).

- Patients who used growth hormone for treatment.

- Subjects took part in other clinical trial study within 3 months.

- Patients used other hormonal for treatment within 3 months (such as sex hormone, glucocorticoid and etc., treat for more than a month) and received the drug treatment which may interfere with the secretion of GH or GH function (oxandrolone, growth hormone releasing hormone and etc.);

- Other conditions which in the opinion of the investigator preclude enrollment into the study.

Género: All

Edad mínima: 3 Years

Edad máxima: 7 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Xiaoping Luo, Ph.D Principal Investigator Tongji Hospital of Tongji Medical College of HUST
Contacto general

Apellido: Xiaohua Feng

Teléfono: 13610794989

Email: [email protected]

Ubicación
Instalaciones: Estado: Contacto:
Tongji Hospital of Tongji Medical College of HUST | Wuhan, Hubei, China Recruiting Xiaoping Luo, Ph.D\
Hunan Children's Hospital | Changsha, Hunan, China Recruiting Yan Zhong
Affiliated Hospital of Jiangnan University | Wuxi, Jiangsu, China Recruiting Zhuangjian Xu
First Hospital of Jilin University | Changchun, Jilin, China Recruiting Hongwei Du
Children's Hospital of Fudan University | Shanghai, Shanghai, China Recruiting Feihong Luo
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai, Shanghai, China Recruiting Xueyuan Gu
Shanxi Provincial Maternity and Children's Hospital | Taiyuan, Shanxi, China Recruiting Wenhui Song
Ubicacion Paises

China

Fecha de verificación

January 2015

Fiesta responsable

Tipo: Sponsor

Tiene acceso ampliado No
Número de brazos 2
Grupo de brazo

Etiqueta: PEG-somatropin: Low dose

Tipo: Experimental

Descripción: 0.1 mg/(kg.w), once per week for 52 weeks.

Etiqueta: PEG-somatropin: High dose

Tipo: Experimental

Descripción: 0.2 mg/(kg.w), once per week for 52 weeks.

Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: Double (Participant, Investigator)

Fuente: ClinicalTrials.gov