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Trial · Interventional

Status unknownPhase 4Registry data

Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children (Clinical Trial I)

NCTNCT02380235 (opens ClinicalTrials.gov in a new tab)Other idGenSci 004 CT-2
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Overview

Status
Status unknown
Phase
Phase 4
Enrollment
600 participants (estimated)
Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

China

Start
Dec 2014
Primary completion
Jun 2017 (estimated)
Completion
Jul 2017 (estimated)
First posted
5 Mar 2015 (estimated)
Last update posted
16 Jun 2017
Conditions
Growth Hormone Deficiency

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20142015201620172018
  1. Ph 4

    Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children (Clinical Trial I)

    NCT02380235

    Dec 2014 to est. Jul 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study evaluates the safety and efficiency of Pegylated Somatropin (PEG Somatropin) Injection in the treatment of endogenous growth hormone deficiency (GHD) in the broad of population of children.

Interventions

  • PEG-somatropinBiological
  • PEG-somatropinBiological

Arms2

  • Experimental

    PEG-somatropin

    0.12mg/kg/w

  • Experimental

    PEG-Somatropin

    0.20mg/kg/w

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Ht SDSca

    Time frame · Baseline, 4,12,26 weeks after initiating treatment

    Registry description

    Ht SDSca was calculated by dividing the difference between the actual height of a patient and the mean height of the population for that chronological age by the standard deviation (SD) of the height of the population for that chronological age

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 3 Years up to 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Before starting treatment, according to the medical history, clinical symptoms and signs, GH stimulation test and imaging examination, patients are diagnosed as GHD. * According to the height statistical data of Chinese children's physique development in nine cities in 2005,height is lower than the third percentile of growth curve of normal children with the same age and gender. * Height velocity (HV) ≤5.0 cm/yr. * GH stimulation test with two different mechanisms affirms that GH peak concentration of patients' plasma\<10.0ng/ml. * Bone age (BA) ≤9 years in girls and ≤10 years in boys, at least 1 year less than his/her chronological age (CA). * Be in preadolescence (Tanner stage 1) and have a CA ≧ 3 years. * Receive no prior GH treatment within 6 months. * Sign informed consent. 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 positive for hepatitis B core antigen (HBc), hepatitis B surface antigen (HBsAg) or hepatitis Be antigen (HBeAg). * People with known highly allergic constitution or allergy to the drug of the study. * People with severe cardiopulmonary, hematological and malignant tumors diseases or general infection and immune deficiency. * Diabetic. * Potential tumor patients (family history). * Abnormal growth and development, such as Turner syndrome, constitutional delay of growth and puberty,Laron syndrome, growth hormone receptor deficiency, girls of growth retardation without excluding abnormal chromosome. * Subjects took part in other clinical trial study within 3 months. * Other conditions which in the opinion of the investigator preclude enrollment into the study.

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