Clinical trial NCT05504083: Evaluate the Efficacy and Safety of D-0120 in Primary Hyperuricemia Patients
Official title: A Multicenter Randomized and Controlled Phase IIb Study to Evaluate the Efficacy and Safety of D-0120 Tablets in Patients with Primary Hyperuricemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperuricemia
Lead sponsor: InventisBio Co., Ltd
Sponsor class: INDUSTRY
First posted: 2022-08-17
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, open-label, parallel-controlled, multicenter clinical trial in primary hyperuricemia patients with or without gout.


Eligibility criteria: Inclusion Criteria:

1. 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;
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:

1. Prior intolerance to benzbromarone or contraindication to medication;
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;

Primary outcomes:
measure: Percentage of subjects with serum uric acid ≤ 360 μmol/L
timeFrame: Day 1 - Day 85
Secondary outcomes:
measure: Percentage of subjects with serum uric acid≤ 360 μmol/L
timeFrame: Day 1 -Day 56
measure: Changes in serum uric acid
timeFrame: Day 1 - Day 85
measure: Change percentage in serum uric acid
timeFrame: Day 1 - Day 85
Other outcomes:
Locations:
city: Baotou
country: China
facility: Inner Mongolia Baogang Hospital
city: Beijing
country: China
facility: Beijing Chao-yang Hospital, Capital Medical University
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Changchun
country: China
facility: The First Hospital of Jilin University
city: Changzhou
country: China
facility: The First People's Hospital of Changzhou
city: Foshan
country: China
facility: Foshan Nanhai People's Hospital
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
city: Guangzhou
country: China
facility: Nanfang Hospital
city: Guangzhou
country: China
facility: The Second People's Hospital of Guangdong Province
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
city: Hengyang
country: China
facility: The First Affiliated Hospital Of University Of South China
city: Huzhou
country: China
facility: Huzhou Third People's Hospital
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology
city: Nanchong
country: China
facility: Affiliated Hospital of North Sichuan Medical College
city: Nanjing
country: China
facility: Gulou Hospital Affiliated to Nanjing University Gulou Hospital Affiliated to Nanjing University
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
city: Ningbo
country: China
facility: Ningbo Huamei Hospital, University of Chinese Academy of Sciences
city: Shanghai
country: China
facility: Changhai Hospital of Shanghai
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
city: Xining
country: China
facility: Qinghai Province People's Hospital
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
city: Zigong
country: China
facility: Zigong Fourth People's Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Xiaofeng Zeng
role: PRINCIPAL_INVESTIGATOR
References: