Health TrialsbyHealthPanel

GB06 Phase III Trial for Pediatric Growth Hormone Deficiency

ConditionsGrowth Hormone Deficiency (GHD)Growth Hormone Deficiency in ChildrenGrowth Hormone Deficiency, Pediatric
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age3-11
SponsorKexing Biopharm Co., Ltd.

About this trial

This study aims to evaluate the efficacy and safety of GB06 (a biosimilar of Norditropin®FlexProTM from Novo Nordisk) for the treatment of growth disorders caused by growth hormone deficiency (GHD) in children.

It aims to determine whether the annual height velocity (an index of height growth rate) in children diagnosed with GHD after 52 weeks of GB06 intervention is comparable to that of Norditropin®FlexProTM. To achieve this, the participants will administer GB06 or Norditropin®FlexProTM at 0.035mg/kg/day for 52 consecutive weeks.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The legal guardian of the participant understands and signs the written informed consent form (ICF); Participants over 8 years old are also required to sign the ICF, and if they are under 8 years old but can express consent, their opinions should be clearly documented.

Age ≥ 3 years old and ≤ 11 years old (boys) or ≤ 10 years old (girls);

Height below two standard deviations (SD) of the average height of children of the same age and gender;

Annual height velocity (AHV) <5cm/year, based on height within 6 months to 18 months before screening;

Disqualifiers

Known allergy to ingredients of the study drug;

Previous treatment with recombinant human growth hormone (rhGH) or IGF-1 or combination with other treatments that may affect growth;

Administration of any investigational drug within 3 months before screening or participation in another clinical trial before randomization;

Small for gestational age;

Trial design

Design model

Parallel

Treatments tested in this trial

  • GB06

    Drug

    GB06 0.035mg/kg/day by subcutaneous injection for 52 weeks

  • Norditropin®FlexProTM

    Drug

    Norditropin®FlexProTM 0.035mg/kg/day by subcutaneous injection for 52 weeks

Treatment groups

192 Participants
are divided into 2 treatment groups
Group A: GB06Experimental treatment 1 intervention
Group B: Norditropin®FlexProTMActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Annual height velocity (AHV) at week 52.

Time frame
From enrollment to the end of treatment at 52 weeks

Secondary outcomes

1

AHV at weeks 5, 13, 26, and 39 and their changes from baseline

Time frame
From enrollment to treatment at 39 weeks
2

AHV standard deviation score (SDS) at weeks 5, 13, 26, 39, and 52, and their change from baseline

Time frame
From enrollment to the end of treatment at 52 weeks
3

Change in height SDS for chronological age (Ht SDS CA) at weeks 5, 13, 26, 39, and 52, and comparison with baseline

Time frame
From enrollment to the end of treatment at 52 weeks
4

Bone age at week 52

Bone age at week 52 will be compared with that from baseline

Time frame
From enrollment to the end of treatment at 52 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kexing Biopharm Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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