Evaluate the Efficacy and Safety of D-0120 in Primary Hyperuricemia Patients
NCT ID: NCT05504083
Last Updated: 2024-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
121 participants
INTERVENTIONAL
2022-09-28
2024-05-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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D-0120 group 1
take D-0120 dose 1 orally during the treatment period.
D-0120
Part A: Randomized in a 1:1:1 ratio through the randomization system, and assigned to D-0120 group 1, D-0120 group 2 or benzbromarone control group. Part B: Subjects will be assigned to D-0120 group 3.
D-0120 group 2
take D-0120 dose 2 orally during the treatment period.
D-0120
Part A: Randomized in a 1:1:1 ratio through the randomization system, and assigned to D-0120 group 1, D-0120 group 2 or benzbromarone control group. Part B: Subjects will be assigned to D-0120 group 3.
Benzbromarone
take benzbromarone orally during the treatment period.
Benzbromarone
Part A: Randomized in a 1:1:1 ratio through the randomization system, and assigned to D-0120 group 1, D-0120 group 2 or benzbromarone control group.
D-0120 group 3
take D-0120 dose 3 orally during the treatment period.
D-0120
Part A: Randomized in a 1:1:1 ratio through the randomization system, and assigned to D-0120 group 1, D-0120 group 2 or benzbromarone control group. Part B: Subjects will be assigned to D-0120 group 3.
Interventions
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D-0120
Part A: Randomized in a 1:1:1 ratio through the randomization system, and assigned to D-0120 group 1, D-0120 group 2 or benzbromarone control group. Part B: Subjects will be assigned to D-0120 group 3.
Benzbromarone
Part A: Randomized in a 1:1:1 ratio through the randomization system, and assigned to D-0120 group 1, D-0120 group 2 or benzbromarone control group.
Eligibility Criteria
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Inclusion Criteria
2. Subject who meets one of the following criteria:
i. History of gout attack: Meeting 2015 ACR/EULAR Gout Classification Criteria and fasting serum uric acid ≥ 480 μmol/L at screening (local laboratory of study site) ii. For asymptomatic hyperuricemia, it is acceptable to meet either of the two criteria:
1. Serum uric acid ≥ 420 μmol/L for at least 3 months (subject to hospital medical record or test report), diagnosis with hyperuricemia before screening, and fasting serum uric acid at screening ≥ 540 μmol/L (local laboratory of study site);
2. Serum uric acid ≥ 420 μmol/L for at least 3 months (subject to hospital medical record or test report), diagnosis with hyperuricemia before screening, and fasting serum uric acid at screening ≥ 480 μmol/L (local laboratory of study site), with concomitant primary hypertension or primary hyperlipidemia or type 2 diabetes mellitus, which is treated with a stable dose of antihypertensive or lipid-lowering or hypoglycemic treatment for at least 3 months;
3. At screening, 18.0 kg/m2 ≤ body mass index (BMI) ≤ 32.0 kg/m2;
4. Hematology, Blood chemistry and Urinalysis examination were basically normal.
Exclusion Criteria
2. Secondary hyperuricemia caused by tumor, chronic kidney disease, blood disease or drugs, etc.;
3. Arthropathy caused by arthritis rheumatoid, purulent arthritis, traumatic arthritis, psoriatic arthritis, pseudogout or systemic lupus erythematosus, etc.;
4. Arthropathy caused by chemotherapy, radiotherapy or chronic lead poisoning;
5. Urinary calculi confirmed by B-ultrasound during screening period;
18 Years
65 Years
ALL
No
Sponsors
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InventisBio Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Xiaofeng Zeng
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Locations
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Inner Mongolia Baogang Hospital
Baotou, , China
Beijing Chao-yang Hospital, Capital Medical University
Beijing, , China
Peking Union Medical College Hospital
Beijing, , China
The First Hospital of Jilin University
Changchun, , China
The First People's Hospital of Changzhou
Changzhou, , China
Foshan Nanhai People's Hospital
Foshan, , China
Guangzhou First People's Hospital
Guangzhou, , China
Nanfang Hospital
Guangzhou, , China
The Second People's Hospital of Guangdong Province
Guangzhou, , China
Zhujiang Hospital of Southern Medical University
Guangzhou, , China
The First Affiliated Hospital Of University Of South China
Hengyang, , China
Huzhou Third People's Hospital
Huzhou, , China
First Affiliated Hospital of Kunming Medical University
Kunming, , China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, , China
Affiliated Hospital of North Sichuan Medical College
Nanchong, , China
Gulou Hospital Affiliated to Nanjing University Gulou Hospital Affiliated to Nanjing University
Nanjing, , China
Zhongda Hospital Southeast University
Nanjing, , China
Affiliated Hospital of Nantong University
Nantong, , China
Ningbo Huamei Hospital, University of Chinese Academy of Sciences
Ningbo, , China
Changhai Hospital of Shanghai
Shanghai, , China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, , China
Qinghai Province People's Hospital
Xining, , China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, , China
Zigong Fourth People's Hospital
Zigong, , China
Countries
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Other Identifiers
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D0120-206
Identifier Type: -
Identifier Source: org_study_id
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