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

NCT03104010 | Unknown Phase 2

• 1 other identifier: GenSci 034 CT
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 9

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.

Conditions

Adult Growth Hormone Deficiency

Outcome Measures

Primary Outcomes (1)

• Fat mass change

  Change from baseline in fat mass (torso) (FM): FM at the end of treatment minus the baseline value

  52 weeks

Secondary Outcomes (11)

• Lean body mass change

  52 weeks

• Blood lipid change

  52 weeks

• Waist circumference change

  52 weeks

• Percentage of body fat change

  52 weeks

• Cardiac function change

  52 weeks

Study Arms (2)

PEG-rhGH-1

EXPERIMENTAL

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

PEG-rhGH-2

EXPERIMENTAL

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

Interventions

Somatropin Injection DRUG

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.

Also known as: Recombinant human growth hormone injection

PEG-rhGH-1; PEG-rhGH-2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead
• Peking Union Medical College Hospital: collaborator
• Peking University First Hospital: collaborator
• Hebei General Hospital: collaborator
• The Second Hospital of Hebei Medical University: collaborator
• Qilu Hospital of Shandong University: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator
• The First Affiliated Hospital of Soochow University: collaborator
• First Affiliated Hospital of Chongqing Medical University: collaborator
• Chongqing Three Gorges Central Hospital: collaborator
• West China Hospital: collaborator

Study Sites (9)

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

NOT YET RECRUITING

Heibei General Hospital

Shijiazhuang, Hebei, 050057, China

NOT YET RECRUITING

The Affiliated hospital of soochow University

Suzhou, Jiangsu, China

NOT YET RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, China

NOT YET RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, China

NOT YET RECRUITING

The Second Affiliated Hospital of Zhejiang University school of medicine

Hangzhou, Zhejiang, China

NOT YET RECRUITING

Peking Union Medical College Hospital

Beijing, 100730, China

RECRUITING

Chongqing Three Gorges Central Hospital

Chongqing, China

NOT YET RECRUITING

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

NOT YET RECRUITING

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

Human Growth Hormone; Growth Hormone

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Hui Pan, Doctor

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaohua Feng, MD

CONTACT

0431-85170552; fengxiaohua@gensci-china.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: April 7, 2017
• Study Start: April 1, 2017
• Primary Completion: February 1, 2022
• Study Completion: September 1, 2022
• Last Updated: April 7, 2017

Record last verified: 2017-03

Locations

CN (9)