Skip to main content
MedPathMedPath Home
Clinical Trials/NCT02946606
NCT02946606
Completed
Phase 2

A Randomized, Active-controlled, Multiple-dose, Open-label Study to Evaluate the Safety, Tolerability, and Efficacy of the Long-acting Antibody-fused Recombinant Human Growth Hormone (GX-H9) in Adult Growth Hormone Deficiency (AGHD)

Genexine, Inc.1 site in 1 country45 target enrollmentJanuary 2015
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsAdult Growth Hormone Deficiency
InterventionsGX-H9Genotropin
DrugsGX-H9Genotropin

Overview

Phase
Phase 2
Intervention
GX-H9
Conditions
Adult Growth Hormone Deficiency
Sponsor
Genexine, Inc.
Enrollment
45
Locations
1
Primary Endpoint
The change in insulin-like growth factor-1 (IGF-1) levels in relation to time and dose strength
Status
Completed
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

This is a randomized, active-controlled, open-label, sequential dose group, Phase 1b/2 study designed to assess the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of weekly and every other week doses of GX-H9 in the treatment of AGHD.

Detailed Description

The subjects who are adequately eligible to attend this clinical trial via screening will be sequentially assigned starting with Group 1. Each group will be comprised of subjects who will receive both GX-H9 and Genotropin, and subjects will be randomly assigned to either GX-H9 and Genotropin in the ratio of 4:1. The treatment will proceed as the proposed group order (Group 1, Group 2, Group 3), and safety and insulin-like growth factor (IGF-1) will be reviewed six weeks after each treatment by the safety monitoring committees before proceeding to the next group.

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
December 30, 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Each subject must meet all of the following criteria to be enrolled in this study:
  • •Is a male or female aged ≥20 and 65 years with AGHD, either adult onset GHD due to hypothalamic pituitary disease or childhood onset GHD that is either idiopathic or due to hypothalamic pituitary disease or due to genetic causes.
  • •Has documented confirmation (medical history) of GH deficiency during adulthood by 1 or more growth hormone (GH) stimulation tests, as follows:
  • •Insulin tolerance test (peak hGH≤3.0 ng/mL)
  • •Arginine + growth-hormone-releasing hormone (peak hGH≤4.0 ng/mL)
  • •Has been treated with stable hormonal replacement therapies for deficiencies of other hypothalamo pituitary axes and must have been on an optimized and stable treatment regimen for at least 3 months before screening (free thyroxine \[T4\] level within normal range at screening). Temporary adjustment of glucocorticoid replacement therapy, as appropriate, is acceptable.
  • •Has a screening IGF-1 level of at least 1 standard deviation (SD) score (IGF-1 SD score \<1) below the mean IGF-1 level standardized for age and gender according to the central laboratory reference values.
  • •Has a BMI of ≥18.0 and 35.0 kg/m2 (both male and female subjects).
  • •Has a confirmed negative test result for anti-recombinant human growth hormone (anti-rhGH) antibodies at screening.
  • •Must agree to use appropriate contraceptive methods (ie, condoms, cervical cap in conjunction with spermicide, sterilization, and intra uterine device) during the study and for 6 months after the last dose of study drug.

Exclusion Criteria

  • •A subject meeting any of the following criteria will be excluded from the study:
  • •Has evidence of growth of pituitary adenoma or other intracranial tumor within the last 12 months which has to be confirmed by computed tomography or magnetic resonance imaging scan (with contrast) within 3 months before screening. (Subjects with inactive remnant intracranial tumors are eligible).
  • •Is currently receiving antitumor therapy and has a history of malignancy other than i) cranial tumor or leukemia causing GHD, or ii) fully treated basal cell carcinoma or evidence of active malignancy.
  • •Has any clinically significant electrocardiogram (ECG) abnormality at screening.
  • •Has evidence of intracranial hypertension at screening.
  • •Has uncontrolled diabetes mellitus with diet and exercise, as determined based on glycated hemoglobin (HbA1c) levels ≥7.0% at screening.
  • •Has impaired liver function defined as elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.0 × upper limit of normal (ULN).
  • •Has impaired kidney function defined as increased serum creatinine levels greater than 1.5 × ULN.
  • •Has had active acromegaly within 18 months before screening.
  • •Has active carpal tunnel syndrome.

Arms & Interventions

Group 1: GX-H9 + Genotropin

GX-H9 (weekly dose), Genotropin (daily)

Intervention: GX-H9

Group 1: GX-H9 + Genotropin

GX-H9 (weekly dose), Genotropin (daily)

Intervention: Genotropin

Group 2: GX-H9 + Genotropin

GX-H9 (weekly dose), Genotropin (daily)

Intervention: GX-H9

Group 2: GX-H9 + Genotropin

GX-H9 (weekly dose), Genotropin (daily)

Intervention: Genotropin

Group 3: GX-H9 + Genotropin

GX-H9 (weekly dose), Genotropin (daily)

Intervention: GX-H9

Group 3: GX-H9 + Genotropin

GX-H9 (weekly dose), Genotropin (daily)

Intervention: Genotropin

Outcomes

Primary Outcomes

The change in insulin-like growth factor-1 (IGF-1) levels in relation to time and dose strength

Time Frame: 12 weeks

Secondary Outcomes

  • Pharmacokinetic (PK) profile of GX-H9 in the treatment of AGHD: Area under the curve, AUC0-t(12 weeks)
  • PK profile of GX-H9 in the treatment of AGHD: Area under the curve, AUC0-inf(12 weeks)
  • PK profile of GX-H9 in the treatment of AGHD: Area under the curve, AUC0-tau(12 weeks)
  • PK profile of GX-H9 in the treatment of AGHD: Maximum serum concentration, Cmax(12 weeks)
  • PK profile of GX-H9 in the treatment of AGHD: The time taken to reach the maximum concentration, Tmax(12 weeks)
  • PK profile of GX-H9 in the treatment of AGHD: Half-life, t1/2(12 weeks)
  • Pharmacodynamic (PD) profile of GX-H9 in the treatment of AGHD: Maximum serum concentration of IGF-1, Cmax(12 weeks)
  • PD profile of GX-H9 in the treatment of AGHD: Area under curve of IGF-1, AUC0-t(12 weeks)
  • PD profile of GX-H9 in the treatment of AGHD: Maximum serum concentration of IGFBP-3, Cmax(12 weeks)
  • PD profile of GX-H9 in the treatment of AGHD: Area under curve of IGFBP-3, AUC0-t(12 weeks)
  • Data in Physical examination, Vital signs, Electrocardiography, Clinical Laboratory Test Results Related to Investigational Product(12 weeks)
  • Immunogenicity Test After subcutaneous injection of GX-H9(12 weeks)
  • The changes of glucose metabolism indices(12 weeks)
  • Data in hormonal status of thyroid, estradiol(female), testosterone(male), and cortisol levels(12 weeks)
  • The lipid parameters as actual values and percent change from baseline (CFB)at week 12: total cholesterol(change from baseline at 12weeks)
  • The lipid parameters as actual values and percent change from baseline (CFB) at week 12: High-density lipoprotein cholesterol(change from baseline at 12weeks)
  • The lipid parameters as actual values and percent change from baseline (CFB) at week 12: low-density lipoprotein cholesterol(change from baseline at 12weeks)
  • The lipid parameters as actual values and percent change from baseline (CFB) at week 12: Triglycerides(change from baseline at 12weeks)
  • The lipid parameters as actual values and percent change from baseline (CFB) at week 12: lipoprotein[a](change from baseline at 12weeks)
  • The waist circumference as actual values and CFB at week 12(change from baseline at 12weeks)
  • The hip circumference as actual values and CFB at week 12(change from baseline at 12weeks)
  • The waist-to-hip ratio as actual values and CFB at week 12(change from baseline at 12weeks)
  • The BMI as actual values and CFB at week 12(change from baseline at 12weeks)

Study Sites (1)

Loading locations...

Similar Trials

Completed
Phase 1
Trial to Evaluate the Safety, Tolerability, and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adult VolunteersShinglesHerpes ZosterVaccine-Preventable Diseases
NCT05245838Dynavax Technologies Corporation150
Completed
Phase 2
Pharmacokinetics,Pharmacodynamics,Efficacy and Safety of HRG2010 in Parkinson's Disease Patients With Motor FluctuationsParkinson's Disease
NCT06614153Jiangsu HengRui Medicine Co., Ltd.61
Completed
Phase 1
Comparative Study of 3 Dose Regimens of BioChaperone to Becaplermin Gel for the Treatment of Diabetic Foot UlcerDiabetic Foot Ulcers
NCT01098357Virchow Group192
Completed
Phase 1
Comparison of the Safety, Efficacy and Pharmacokinetics of DehydraTECH -CBD and DehydraTECH-GLP1 Agonists Alone or in Combination, in Overweight or Obese, Pre- and Type 2 Diabetic ParticipantsType2diabetes
NCT06648031Lexaria Bioscience Corp.148
Terminated
Phase 2
Study of Local Administration of DepoTXA for Reduced Postsurgical Bleeding in Subjects Undergoing TKATotal Knee Arthroplasty
NCT02922582Pacira Pharmaceuticals, Inc16