This trial is a phase II clinical trial to evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of octreotide long-acting injection in patients with acromegaly.
This study is a randomized, parallel-group, multicenter phase II clinical trial to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of long-acting octreotide 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 84 participants are expected to be enrolled. The study will consist of a maximum 4-week screening/Baseline period, followed by 12-week treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
78
The patients will accept SYHX2008 injection by subcutaneous administration.A treatment period of 12 weeks.
The patients will accept Sandostatin LAR by intra-muscular administration.A treatment period of 12 weeks.
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
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 12
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
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
The proportion of patients with fasting GH < 1.0 ng/mL.
Time frame: Weeks 4、8、12
The proportion of patients with fasting GH<2.5 ng/mL
Time frame: Weeks 4、8、12
The proportion of patients with an IGF-1 index ≤ 1.0
Time frame: Weeks 4、8
The proportion of patients with an IGF-1 index < 1.3
Time frame: Weeks 12
The rate of change in the volume of the pituitary tumor from the baseline.
Time frame: Weeks12
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: Weeks4、8、12
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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 4、8、12
The proportion of patients treated with remedial drugs.
Time frame: Weeks 4、8、12
The proportion of patients with fasting GH decreased by ≥50% compared to the baseline.
Time frame: Weeks 4、8、12
The proportion of patients whose IGF-1 index decreased by ≥50% compared with the baseline.
Time frame: Weeks 4、8、12