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

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ClinicalTrials.gov Identifier: NCT03104010
Recruitment Status : Recruiting
First Posted : April 7, 2017
Last Update Posted : April 7, 2017
Sponsor:
Collaborators:
Peking Union Medical College Hospital
Peking University First Hospital
Hebei General Hospital
The Second Hospital of Hebei Medical University
Qilu Hospital of Shandong University
Second Affiliated Hospital, School of Medicine, Zhejiang University
The First Affiliated Hospital of Soochow University
First Affiliated Hospital of Chongqing Medical University
Chongqing Three Gorges Central Hospital
West China Hospital
Information provided by (Responsible Party):
GeneScience Pharmaceuticals Co., Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Adult Growth Hormone Deficiency Drug: Somatropin Injection Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Non-inferiority Phase 2 Study to Evaluate the Safety and Efficacy of PEG-rhGH in the Treatment of Adult Growth Hormone Deficiency (AGHD)
Estimated Study Start Date : April 2017
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : September 2022


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 Name: 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 Name: Recombinant human growth hormone injection




Primary Outcome Measures :
  1. Fat mass change [ Time Frame: 52 weeks ]
    Change from baseline in fat mass (torso) (FM): FM at the end of treatment minus the baseline value


Secondary Outcome Measures :
  1. Lean body mass change [ Time Frame: 52 weeks ]
    Change from baseline in lean body mass (LBM): LBM at the end of treatment minus the baseline value

  2. Blood lipid change [ Time Frame: 52 weeks ]
    Change from baseline in blood lipid: blood lipid at the end of treatment minus the baseline value

  3. Waist circumference change [ Time Frame: 52 weeks ]
    Change from baseline in waist circumference: waist circumference at the end of treatment minus the baseline value

  4. Percentage of body fat change [ Time Frame: 52 weeks ]
    Change from baseline in the percentage of body fat: TBF at the end of treatment minus the baseline value

  5. Cardiac function change [ Time Frame: 52 weeks ]
    Change from baseline in cardiac function: ejection fraction at the end of treatment minus the baseline value

  6. Cardiac structure change [ Time Frame: 52 weeks ]
    Change from baseline in cardiac structure: left ventricular mass at the end of treatment minus the baselines value

  7. IGF-1 change [ Time Frame: 52 weeks ]
    Changes from baseline in IGF-1: IGF-1 SDS at the end of treatment minus the baseline value

  8. Grip change [ Time Frame: 52 weeks ]
    Changes from baseline in grip: grip at the end of treatment minus the baseline value, the method of assessment is measurement.

  9. Quality of life change [ Time Frame: 52 weeks ]
    Changes from baseline in quality of life (QOL): changes in QOL scores before and after treatment

  10. Waist-hip ratio change [ Time Frame: 52 weeks ]
    Changes from baseline in waist-hip ratio: changes of waist-hip ratio before and after treatment

  11. Cardiac structure change [ Time Frame: 52 weeks ]
    Change from baseline in cardiac structure: carotid intima media thickness at the end of treatment minus the baselines value



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03104010


Contacts
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Contact: Xiaohua Feng, MD 0431-85170552 fengxiaohua@gensci-china.com

Locations
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China, Hebei
The Second Hospital of Hebei Medical University Not yet recruiting
Shijiazhuang, Hebei, China, 050000
Contact: Songjun Zhang, Doctor         
Heibei General Hospital Not yet recruiting
Shijiazhuang, Hebei, China, 050057
China, Jiangsu
The Affiliated hospital of soochow University Not yet recruiting
Suzhou, Jiangsu, China
China, Shandong
Qilu Hospital of Shandong University Not yet recruiting
Jinan, Shandong, China
Contact: Ling Jiang, Doctor         
China, Sichuan
West China Hospital, Sichuan University Not yet recruiting
Chengdu, Sichuan, China
Contact: Zhenmei An, Doctor         
China, Zhejiang
The Second Affiliated Hospital of Zhejiang University school of medicine Not yet recruiting
Hangzhou, Zhejiang, China
Contact: Wei Gu, Doctor         
China
Peking Union Medical College Hospital Recruiting
Beijing, China, 100730
Contact: Hui Pan, Doctor         
Chongqing Three Gorges Central Hospital Not yet recruiting
Chongqing, China
Contact: Yong Luo, Doctor         
The First Affiliated Hospital of Chongqing Medical University Not yet recruiting
Chongqing, China
Contact: Wei Ren, Doctor         
Sponsors and Collaborators
GeneScience Pharmaceuticals Co., Ltd.
Peking Union Medical College Hospital
Peking University First Hospital
Hebei General Hospital
The Second Hospital of Hebei Medical University
Qilu Hospital of Shandong University
Second Affiliated Hospital, School of Medicine, Zhejiang University
The First Affiliated Hospital of Soochow University
First Affiliated Hospital of Chongqing Medical University
Chongqing Three Gorges Central Hospital
West China Hospital
Investigators
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Principal Investigator: Hui Pan, Doctor Peking Union Medical College Hospital

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Responsible Party: GeneScience Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT03104010     History of Changes
Other Study ID Numbers: GenSci 034 CT
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: March 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Dwarfism, Pituitary
Dwarfism
Endocrine System Diseases
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs