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This is a randomized, open-label, parallel-controlled, multicenter clinical trial in primary hyperuricemia patients with or without gout.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D-0120 group 1 | Experimental | take D-0120 dose 1 orally during the treatment period. |
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| D-0120 group 2 | Experimental | take D-0120 dose 2 orally during the treatment period. |
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| Benzbromarone | Active Comparator | take benzbromarone orally during the treatment period. |
|
| D-0120 group 3 | Experimental | take D-0120 dose 3 orally during the treatment period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-0120 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with serum uric acid ≤ 360 μmol/L | Percentage of subjects with serum uric acid ≤ 360 μmol/L at week 12 of treatment - based on test results by the central lab. | Day 1 - Day 85 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with serum uric acid≤ 360 μmol/L | Percentage of subjects with serum uric acid ≤ 360 μmol/L at weeks 4 and 8 of treatment - based on test results by the central lab; | Day 1 -Day 56 |
| Changes in serum uric acid |
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Inclusion Criteria:
Subject voluntarily takes part in the study after being fully informed,signs a written ICF, and agrees to follow procedures specified in the study protocol;
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:
At screening, 18.0 kg/m2 ≤ body mass index (BMI) ≤ 32.0 kg/m2;
Hematology, Blood chemistry and Urinalysis examination were basically normal.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaofeng Zeng | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inner Mongolia Baogang Hospital | Baotou | China | ||||
| Beijing Chao-yang Hospital, Capital Medical University |
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| Benzbromarone | Drug | 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. |
|
Changes in serum uric acid from baseline at weeks 4, 8 and 12 of treatment - based on test results by the central lab;
| Day 1 - Day 85 |
| Change percentage in serum uric acid | Change percentage in serum uric acid from baseline at weeks 4, 8 and 12 of treatment - based on test results by the central lab. | Day 1 - Day 85 |
| 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 |
| ID | Term |
|---|---|
| D033461 | Hyperuricemia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001553 | Benzbromarone |
| ID | Term |
|---|---|
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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