A Non-inferiority Phase 2 Study to Evaluate the Safety and Efficacy of PEG-rhGH in the Treatment of AGHD

A Non-inferiority Phase 2 Study to Evaluate the Safety and Efficacy of PEG-rhGH in the Treatment of Adult Growth Hormone Deficiency (AGHD)

This study aims to explore the optimal dose of PEG-rhGH injection in the treatment of AGHD, preliminarily evaluate its safety and efficacy, to provide scientific and reliable evidence for the medication dosage in Phase 2 clinical study.

Study Overview

• Status: Unknown
• Conditions: Adult Growth Hormone Deficiency
• Intervention / Treatment: Drug: Somatropin Injection

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xiaohua Feng, MD; Phone Number: 0431-85170552; Email: fengxiaohua@gensci-china.com

Study Locations

• China
  • Beijing, China, 100730
    • Recruiting
    • Peking Union Medical College Hospital
    • Contact: Hui Pan, Doctor
  • Chongqing, China
    • Not yet recruiting
    • The First Affiliated Hospital of Chongqing Medical University
    • Contact: Wei Ren, Doctor
  • Chongqing, China
    • Not yet recruiting
    • Chongqing Three Gorges Central Hospital
    • Contact: Yong Luo, Doctor
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • Not yet recruiting
      • The Second Hospital of Hebei Medical University
      • Contact: Songjun Zhang, Doctor
    • Shijiazhuang, Hebei, China, 050057
      • Not yet recruiting
      • Heibei General Hospital
  • Jiangsu
    • Suzhou, Jiangsu, China
      • Not yet recruiting
      • The Affiliated Hospital of Soochow University
  • Shandong
    • Jinan, Shandong, China
      • Not yet recruiting
      • Qilu Hospital of Shandong University
      • Contact: Ling Jiang, Doctor
  • Sichuan
    • Chengdu, Sichuan, China
      • Not yet recruiting
      • West China Hospital, Sichuan University
      • Contact: Zhenmei An, Doctor
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Not yet recruiting
      • The Second Affiliated Hospital of Zhejiang University School of Medicine
      • Contact: Wei Gu, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Before the treatment, the subject should be diagnosed as AGHD based on medical history, clinical symptoms, vital signs, insulin tolerance test and imagological examinations.

  • The subject is diagnosed as GHD during childhood and remains as GHD in adulthood, and the linear growth has completed: bone age (BA) ≥18 years old; or the AGHD patient who experiences paroxysm after 18 years old: such as patients who have experienced pituitary surgeries (2 years after pituitary adenoma surgery, 5 years after craniopharyngioma surgery and 12 months after other pituitary surgeries), traumatic brain injury (TBI), Sheehan syndrome, and etc..
  • The plasma GH concentration peak is <5ng/ml in insulin tolerance test (ITT) (it's unnecessary to conduct ITT in the following conditions: anterior pituitary dysfunction, pituitary hormone deficiency (more than 3 hormones) and serum IGF-1 level below lower limit of normal value: i.e. -2 SD).
• Age: 18-60 years old.
• Patients with no history of GH treatment for more than one year.
• Body mass index (BMI): 18.5 kg/m2≤BMI≤30kg/m2.
• When there is other hormones deficiency (such as glucocorticoids, thyroid hormones and sex steroids), the subject should have received other hormone replacement therapies and the therapeutic dose shall be stable within 3 months before the enrolment.
• The subject agrees to cooperate and complete the concerted trial procedures such as follow-ups, treatment plan and laboratory examinations, and sign the written informed consent.

Exclusion Criteria:

• Patients with serious heart diseases, including NYHA III or above, serious arrhythmia, unstable angina pectoris or myocardial infarction within the latest 6 months.
• Patients with a history of ischemic cerebrovascular disease, febrile convulsion and epilepsy seizures.
• Patients with carpal tunnel syndrome.
• Patients with poor hypertension control (systolic pressure>140mmHg or diastolic pressure >90mmHg under treatment).
• Patients with previous or present history of malignant tumor: two or more direct relatives within three generations have previous or present history of tumor.
• Patients undergoing anti-depressive therapy, immunosuppressive therapy, chemotherapy and radiotherapy (or with a history of radiotherapy).
• Patients who have ever taken antiobesity drug within the latest 3 months.
• Patients with serious infection.
• Patients with consciousness disorders and mental diseases.
• Subjects with impaired glucose regulation (IGR) (impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) ) or diabetes; patients with a family history of diabetes (direct relatives).
• Subjects with abnormal liver and kidney functions (ALT > 2 times of upper limit of normal value; eGFR calculated by MDRD formula <60).
• Subjects positive for anti-HBc, HBsAg or HBeAg in Hepatitis B virus tests.
• Subjects with highly allergic constitution or allergy to proteins or investigational productorits excipient in this study.
• Subjects who took part in other clinical trials within 3 months.
• Patients with other mental or physical deficiencies that influence the evaluation of investigational product.
• Pregnant or lactating women; females planning to get pregnant within one year.
• Subjects whose tumor markers exceed the upper limit of normal range and the re-examination result is still high.
• Other conditions which is unsuitable for the study in the opinion of the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PEG-rhGH-1; Pegylated recombinant human growth hormone injection, 12IU/2.0mg/1.0ml/bottle. The first stage, 1-2mg/2-4mg, subcutaneous injection,weekly, 26 weeks.	Drug: Somatropin Injection; Recombinant human growth hormone injection, 15IU/5mg/3ml/bottle. The first stage , 0.17mg/d(0.5IU/d), subcutaneous injection ,daily, 26weeks. The second stage(extension period study), 0.17mg/d(0.5IU/d), maximum ≤0.68mg/d (2IU/w),52 weeks.; Other Names: Recombinant human growth hormone injection
EXPERIMENTAL: PEG-rhGH-2; Pegylated recombinant human growth hormone injection, 12IU/2.0mg/1.0ml/bottle. The second stage (extension period study), maximum ≤4mg/w (24IU/w), 52 weeks.	Drug: Somatropin Injection; Recombinant human growth hormone injection, 15IU/5mg/3ml/bottle. The first stage , 0.17mg/d(0.5IU/d), subcutaneous injection ,daily, 26weeks. The second stage(extension period study), 0.17mg/d(0.5IU/d), maximum ≤0.68mg/d (2IU/w),52 weeks.; Other Names: Recombinant human growth hormone injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fat mass change	Change from baseline in fat mass (torso) (FM): FM at the end of treatment minus the baseline value	52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lean body mass change	Change from baseline in lean body mass (LBM): LBM at the end of treatment minus the baseline value	52 weeks
Blood lipid change	Change from baseline in blood lipid: blood lipid at the end of treatment minus the baseline value	52 weeks
Waist circumference change	Change from baseline in waist circumference: waist circumference at the end of treatment minus the baseline value	52 weeks
Percentage of body fat change	Change from baseline in the percentage of body fat: TBF at the end of treatment minus the baseline value	52 weeks
Cardiac function change	Change from baseline in cardiac function: ejection fraction at the end of treatment minus the baseline value	52 weeks
Cardiac structure change	Change from baseline in cardiac structure: left ventricular mass at the end of treatment minus the baselines value	52 weeks
IGF-1 change	Changes from baseline in IGF-1: IGF-1 SDS at the end of treatment minus the baseline value	52 weeks
Grip change	Changes from baseline in grip: grip at the end of treatment minus the baseline value, the method of assessment is measurement.	52 weeks
Quality of life change	Changes from baseline in quality of life (QOL): changes in QOL scores before and after treatment	52 weeks
Waist-hip ratio change	Changes from baseline in waist-hip ratio: changes of waist-hip ratio before and after treatment	52 weeks
Cardiac structure change	Change from baseline in cardiac structure: carotid intima media thickness at the end of treatment minus the baselines value	52 weeks

Collaborators and Investigators

• Sponsor: GeneScience Pharmaceuticals Co., Ltd.
• Collaborators: Peking University First Hospital; Peking Union Medical College Hospital; The Second Hospital of Hebei Medical University; West China Hospital; Qilu Hospital of Shandong University; Second Affiliated Hospital, School of Medicine, Zhejiang University; Hebei General Hospital; The First Affiliated Hospital of Soochow University; First Affiliated Hospital of Chongqing Medical University; Chongqing Three Gorges Central Hospital
• Investigators: Principal Investigator: Hui Pan, Doctor, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2017
• Primary Completion (ANTICIPATED): February 1, 2022
• Study Completion (ANTICIPATED): September 1, 2022

Study Registration Dates

• First Submitted: March 28, 2017
• First Submitted That Met QC Criteria: March 31, 2017
• First Posted (ACTUAL): April 7, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 7, 2017
• Last Update Submitted That Met QC Criteria: March 31, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Musculoskeletal Diseases; Hypothalamic Diseases; Bone Diseases; Bone Diseases, Endocrine; Pituitary Diseases; Dwarfism; Bone Diseases, Developmental; Hypopituitarism; Dwarfism, Pituitary; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormones
• Other Study ID Numbers: GenSci 034 CT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No