he purpose of this study is to evaluate the efficacy and safety of SYHX2008 injection in in patients with acromegaly.
This study is a randomized, parallel, open-label, multicenter, positive-controlled, superiority-designed Phase III clinical study evaluating the efficacy and safety of octreotide long-acting injection in patients with acromegaly. The purpose of this study is to evaluate the efficacy and safety of SYHX2008 injection in treating acromegaly. Patients will be randomized to SYHX2008 cohort or Octreotide Microspheres(Sandostatin LAR®) cohort. A total of 154 participants are expected to be enrolled. The study will consist of a maximum 4-week screening/Baseline period, followed by 28-week treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
154
The patients will accept SYHX2008 injection by subcutaneous administration.A treatment period of 28 weeks.
The patients will accept Sandostatin LAR@ by intra-muscular administration.A treatment period of 28 weeks.
The proportion of patients with an IGF-1 index ≤ 1.0
insulin-like growth factor-1 within the normal range after adjustment for age and gender, where IGF-1 index = IGF-1 value/ULN, and ULN is the upper limit of the normal reference range
Time frame: Week 28
The proportion of patients with fasting GH less than 2.5 ng/mL and IGF-1 index less than or equal to 1.0
Time frame: weeks 4、8、12、16、20、24、28
The proportion of patients with GH less than 1.0 ng/mL and IGF-1 index less than or equal to 1.0
Time frame: weeks 4、8、12、16、20、24、28
The proportion of patients with fasting GH < 1.0 ng/mL
Time frame: Weeks 4、8、12、16、20、24、28
The proportion of patients with fasting GH<2.5 ng/mL
Time frame: Weeks 4、8、12、16、20、24、28
The proportion of patients with an IGF-1 index ≤ 1.0
insulin-like growth factor-1 within the normal range after adjustment for age and gender, where IGF-1 index = IGF-1 value/ULN, and ULN is the upper limit of the normal reference range
Time frame: Weeks 4、8、12、16、20、24
The rate of change in the volume of the pituitary tumor from the baseline
Time frame: Weeks 28
The change in the total PASQ score from the baseline
Evaluation of effect on was assessed using Patient Assessed Acromegaly Symptom Question ( PASQ ), an acromegaly-specific quality of life instrument.
Time frame: Weeks 12、28
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The change in the total AcroQoL score from the baseline
Evaluation of effect was assessed using Acromegaly Quality of Life Questionnaire(AcroQoL), an acromegaly-specific quality of life instrument.
Time frame: Weeks 12、28
The proportion of patients with fasting GH decreased by ≥50% compared to the baseline
Time frame: Weeks 4、8、12、16、20、24、28
The proportion of patients whose IGF-1 index decreased by ≥50% compared with the baseline
Time frame: Weeks 4、8、12、16、20、24、28
Percentage changes in fasting GH from baseline
Time frame: Weeks 4、8、12、16、20、24、28
Percentage changes in IGF-1 from baseline
Time frame: Weeks 4、8、12、16、20、24、28
Incidence of adverse events (AE)
Proportion of subjects with adverse events (AEs) within Weeks 28
Time frame: From the signing of informed consent up to 28 Weeks after the first dose
The concentration of octreotide
The concentration of octreotide in the plasma of patients with acromegaly after administration of SYHX2008 injection and Sandostatin LAR®
Time frame: From the signing of informed consent up to 28 Weeks afterthe first dose