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Trial · Interventional

CompletedPhase 2Registry data

Efficiency and Safety Study of Pegylated Somatropin to Treat Growth Hormone Deficiency Children

Short name PD

NCTNCT01342146 (opens ClinicalTrials.gov in a new tab)Other idGenSci-004 CT
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
101 participants (actual)
Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
Design
Randomized · Open label (no masking)
Countries
Not stated
Start
May 2006
Primary completion
Jan 2007
Completion
Feb 2007
First posted
27 Apr 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
200620072008
  1. Ph 2

    PD

    NCT01342146

    May 2006 to Feb 2007

Registry summary

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

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.

Interventions

  • pegylated SomatropinDrug
  • pegylated SomatropinDrug
  • Jintropin AQDrug

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Growth velocity

    Time frame · 25 weeks

Secondary outcomes(3)

  1. height standard deviation score for chronological age (Ht SDSCA)

    Time frame · 25 weeks

  2. IGF-1

    Time frame · 25 weeks

  3. IGFBP3

    Time frame · 25 weeks

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
Not stated
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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