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

  • STATUS
    Recruiting
  • days left to enroll
    89
  • participants needed
    180
  • sponsor
    GeneScience Pharmaceuticals Co., Ltd.
Updated on 25 February 2022
insulin
body mass index
pituitary
tolerance test
glucocorticoids
pituitary hormone
replacement therapy
other hormones
somatropin
brain injury
peg-rhgh

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.

Details
Condition Adult Growth Hormone Deficiency
Treatment Somatropin Injection
Clinical Study IdentifierNCT03104010
SponsorGeneScience Pharmaceuticals Co., Ltd.
Last Modified on25 February 2022

Eligibility

Yes No Not Sure

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/m2BMI30kg/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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note