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Growth Hormone DeficiencyPhase 3NCT01495468

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

A Phase 3 study testing PEG-somatropin in people with Growth Hormone Deficiency, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 6 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This was a multicenter, randomized, open-label, parallel controlled phase III study, compared pegylated somatropin with Jintropin AQ (somatropin liquid injection, daily administration formulation). Read more about this study

Who is it for?
Ages 8 to 15 years
Conditions the study is for
Growth Hormone Deficiency
What is being tested?
PEG-somatropin
How many people
343 participants
Where
6 sitesChina
Study dates
Mar 2007to Mar 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • Study site

    Beijing

  • Study site

    Changchun

  • Study site

    Guangzhou

  • Study site

    Hangzhou

  • Study site

    Shanghai

  • Study site

    Wuhan

Other trials in China

About this study

Official title: Pegylated Somatropin in the Treatment of Children With Growth Hormone Deficient：A Multicenter, Randomized, Open-label, Controlled Phase Ⅲ Clinical Trial

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.

Being tested
PEG-somatropin
Keywords
pegylated somatropin, PEG-rhGH, growth hormone, Growth Hormone Deficiency, phase III study
Medical subject headings
Dwarfism, Pituitary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PEG-somatropinBiological

    Also called recombinant human growth hormone, peglyated growth hormone, PEG-GH

    drug:pegylated somatropin 0.2mg/(kg.w), once per week for 6 months drug: Jintropin AQ, 0.25mg/(kg.w), once per day for 6 months

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. yearly growth velocity

    growth velocity add as GV was the primary outcome measure

    Measured: 6 months

Secondary outcomes (4)

  1. Ht SDSca

    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

    Measured: 6 months

  2. IGF-l

    Measured: 6 months

  3. IGFBP-3

    Measured: 6 months

  4. bone maturity

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2011 (estimated)
  2. Study startMar 2007
  3. Primary completionJan 2008
  4. Study completionMar 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
343 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01495468
Sponsor's protocol ID
GenSci-004-CT
Status last verified
Dec 2011
First submitted
16 Dec 2011
Last updated
31 Jul 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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. Eur J Endocrinol. 2017 Aug;177(2):195-205. doi: 10.1530/EJE-16-0905. Epub 2017 May 31.

    PubMed 28566441

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PEG-somatropin in people with Growth Hormone Deficiency, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 6 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

yearly growth velocity (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01495468, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2017; AzTrials last refreshed its copy on 8 Nov 2026.

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