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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03104010
• Date of registration: 28/03/2017
• Prospective Registration: Yes
• Primary sponsor: GeneScience Pharmaceuticals Co., Ltd.
• Public title: A Non-inferiority Phase 2 Study to Evaluate the Safety and Efficacy of PEG-rhGH in the Treatment of AGHD
• Scientific 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)
• Date of first enrolment: April 2017
• Target sample size: 180
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03104010
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

China

Contacts

• Name: Hui Pan, Doctor
• Affiliation: Peking Union Medical College Hospital

• Name: Xiaohua Feng, MD

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Adult Growth Hormone Deficiency

Intervention(s)

Drug: Somatropin Injection

Primary Outcome(s)

Fat mass change [Time Frame: 52 weeks]

Secondary Outcome(s)

Grip change [Time Frame: 52 weeks]

Blood lipid change [Time Frame: 52 weeks]

Quality of life change [Time Frame: 52 weeks]

Cardiac function change [Time Frame: 52 weeks]

Cardiac structure change [Time Frame: 52 weeks]

IGF-1 change [Time Frame: 52 weeks]

Waist-hip ratio change [Time Frame: 52 weeks]

Waist circumference change [Time Frame: 52 weeks]

Lean body mass change [Time Frame: 52 weeks]

Percentage of body fat change [Time Frame: 52 weeks]

Secondary ID(s)

GenSci 034 CT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Peking University First Hospital

Second Affiliated Hospital, School of Medicine, Zhejiang University

First Affiliated Hospital of Chongqing Medical University

West China Hospital

Chongqing Three Gorges Central Hospital

Qilu Hospital of Shandong University

The First Affiliated Hospital of Soochow University

The Second Hospital of Hebei Medical University

Hebei General Hospital

Peking Union Medical College Hospital