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Growth Hormone DeficiencyPhase 2PDNCT01342146

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

A Phase 2 study testing pegylated Somatropin and Jintropin AQ in people with Growth Hormone Deficiency, run by Changchun GeneScience Pharmaceutical Co., Ltd..

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

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Growth Hormone Deficiency
What is being tested?
pegylated Somatropin and Jintropin AQ
Type of treatment
Injection or infusion
How many people
101 participants
Where
No sites listed yet
Study dates
May 2006to Feb 2007
Phase
Phase 2
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
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  • 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

About this study

Official title: Efficiency and Safety of Pegylated Somatropin(PEG-somatropin) in the Treatment of Children With Growth Hormone Deficiency: a Multicenter, Randomized, Open-label, Controlled Phase 2 Study

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.

Being tested
pegylated Somatropin, Jintropin AQ
Keywords
pegylated Somatropin, PEG-GH, Growth hormone, PEG-rhGH, Growth hormone deficiency (GHD), Phase 2 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.

  • pegylated SomatropinDrug

    Also called PEG-rhGH,PEG-growth hormone,PEG-Somatropin

    0.1 mg/kg/wk once a week for 25 weeks

  • pegylated SomatropinDrug

    Also called PEG-rhGH,PEG-growth hormone,PEG-Somatropin

    0.2 mg/kg/wk once a week for 25 weeks

  • Jintropin AQDrug

    Also called Somatropin injectable solution,rhGH injection

    0.25 mg/kg/wk, once a day for 25 weeks

What is being measured

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

  1. Growth velocity

    Measured: 25 weeks

Secondary outcomes (3)

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

    Measured: 25 weeks

  2. IGF-1

    Measured: 25 weeks

  3. IGFBP3

    Measured: 25 weeks

Timeline

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

  1. First posted27 Apr 2011 (estimated)
  2. Study startMay 2006
  3. Primary completionJan 2007
  4. Study completionFeb 2007

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01342146
Sponsor's protocol ID
GenSci-004 CT
Acronym
PD
Status last verified
May 2011
First submitted
21 Apr 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 2 study testing pegylated Somatropin and Jintropin AQ in people with Growth Hormone Deficiency, run by Changchun GeneScience Pharmaceutical Co., Ltd..

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 10 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.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Growth velocity (time frame: 25 weeks). 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 NCT01342146, 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.

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