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Trial · Interventional

CompletedPhase 3Registry data

Phase III Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children

NCTNCT01495468 (opens ClinicalTrials.gov in a new tab)Other idGenSci-004-CT
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
343 participants (actual)
Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

China

Start
Mar 2007
Primary completion
Jan 2008
Completion
Mar 2008
First posted
20 Dec 2011 (estimated)
Last update posted
31 Jul 2017
Conditions
Growth Hormone Deficiency

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200720082009
  1. Ph 3

    Phase III Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children

    NCT01495468

    Mar 2007 to Mar 2008

Registry summary

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

This was a multicenter, randomized, open-label, parallel controlled phase III study, compared pegylated somatropin with Jintropin AQ (somatropin liquid injection, daily administration formulation). All the subjects were randomized into two groups, test group (PEG somatorpin) and control group (Jintropin AQ), 200 children were enrolled in test group and 100 children were enrolled in control group. Considering the case loss during the clinical study, 20% of the patients were added in each of the group, that is 240 children were in test group and 120 children were in control group, totally 360 children were enrolled in the phase III clinical study. Whole treatment were lasted for 6 months, 4 times of follow-up were carried out at the point of baseline, 1 month, 3 month and 6 month after treatment. The evaluation of the primary time point was 3 month and 6 month after treatment, if the treatment was less than 6 months, the evaluation would be made when the treatment is finished.

Interventions

  • PEG-somatropinBiological

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. yearly growth velocity

    Time frame · 6 months

    Registry description

    growth velocity add as GV was the primary outcome measure

Secondary outcomes(4)

  1. Ht SDSca

    Time frame · 6 months

    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

  2. IGF-l

    Time frame · 6 months

  3. IGFBP-3

    Time frame · 6 months

  4. bone maturity

    Time frame · 6 months

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.

Completed trials do not always post results.

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2017

4 results

Long-acting PEGylated recombinant human growth hormone (Jintrolong) for children with growth hormone deficiency: phase II and phase III multicenter, randomized studies.

Luo et al. 2017European journal of endocrinologycited by 89

PMID 28566441PMC5488390DOI 10.1530/eje-16-0905PUB-28566441

CC BY4 results
Download PDFSee results (4)

Eligibility

Who could join, as posted.

Sex
All
Age
from 8 Years up to 15 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 1\. Subjects have a height less than two standard deviations (SD) below the median height for individuals of he same age or height,the growth velocity (CV≤4.0 cm/yr),GH peak concentration \<7.0ng/ml in two difference provocative tests, Bone age (BA) ≤9 years in girls and ≤10 years in boys, at least 2 year 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: * 1\. patients positive for hepatitis B e-antibody (HBeAb), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg) * 2.Known hypersensitivity to Somatropin or any other components of the study product. * 3\. severe cardiopulmonary or hematological diseases, a current or past history of malignant tumors, immunodeficiency diseases, or mental diseases * 4\. with other growth disorders, such as Turner syndrome, constitutional delay of growth and puberty, and Laron syndrome * 5\. Subjects took part in other clinical trial study during 3 months. * 6\. Other conditions which in the opinion of the investigator preclude enrollment into the study.

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