Evaluate the Efficacy and Safety of D-0120 in Primary Hyperuricemia Patients

Last updated: October 10, 2024
Sponsor: InventisBio Co., Ltd
Overall Status: Completed

Phase

2

Condition

Gout (Hyperuricemia)

Treatment

D-0120

Benzbromarone

Clinical Study ID

NCT05504083
D0120-206
  • Ages 18-65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject voluntarily takes part in the study after being fully informed,signs awritten 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 andfasting 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 twocriteria:

  3. Serum uric acid ≥ 420 μmol/L for at least 3 months (subject to hospital medicalrecord or test report), diagnosis with hyperuricemia before screening, andfasting serum uric acid at screening ≥ 540 μmol/L (local laboratory of studysite);

  4. Serum uric acid ≥ 420 μmol/L for at least 3 months (subject to hospital medicalrecord or test report), diagnosis with hyperuricemia before screening, andfasting serum uric acid at screening ≥ 480 μmol/L (local laboratory of studysite), with concomitant primary hypertension or primary hyperlipidemia or type 2 diabetes mellitus, which is treated with a stable dose of antihypertensive orlipid-lowering or hypoglycemic treatment for at least 3 months;

  5. At screening, 18.0 kg/m2 ≤ body mass index (BMI) ≤ 32.0 kg/m2;

  6. Hematology, Blood chemistry and Urinalysis examination were basically normal.

Exclusion

Exclusion Criteria:

  1. Prior intolerance to benzbromarone or contraindication to medication;

  2. Secondary hyperuricemia caused by tumor, chronic kidney disease, blood disease ordrugs, 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;

Study Design

Total Participants: 121
Treatment Group(s): 2
Primary Treatment: D-0120
Phase: 2
Study Start date:
September 28, 2022
Estimated Completion Date:
May 18, 2024

Connect with a study center

  • Inner Mongolia Baogang Hospital

    Baotou,
    China

    Site Not Available

  • Beijing Chao-yang Hospital, Capital Medical University

    Beijing,
    China

    Site Not Available

  • Peking Union Medical College Hospital

    Beijing,
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun,
    China

    Site Not Available

  • The First People's Hospital of Changzhou

    Changzhou,
    China

    Site Not Available

  • Foshan Nanhai People's Hospital

    Foshan,
    China

    Site Not Available

  • Guangzhou First People's Hospital

    Guangzhou,
    China

    Site Not Available

  • Nanfang Hospital

    Guangzhou,
    China

    Site Not Available

  • The Second People's Hospital of Guangdong Province

    Guangzhou,
    China

    Site Not Available

  • Zhujiang Hospital of Southern Medical University

    Guangzhou,
    China

    Site Not Available

  • The First Affiliated Hospital of Hainan Medical College

    Haikou,
    China

    Site Not Available

  • The First Affiliated Hospital Of University Of South China

    Hengyang,
    China

    Site Not Available

  • Huzhou Third People's Hospital

    Huzhou,
    China

    Site Not Available

  • First Affiliated Hospital of Kunming Medical University

    Kunming,
    China

    Site Not Available

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang,
    China

    Site Not Available

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong,
    China

    Site Not Available

  • Gulou Hospital Affiliated to Nanjing University Gulou Hospital Affiliated to Nanjing University

    Nanjing,
    China

    Site Not Available

  • Zhongda Hospital Southeast University

    Nanjing,
    China

    Site Not Available

  • Affiliated Hospital of Nantong University

    Nantong,
    China

    Site Not Available

  • Ningbo Huamei Hospital, University of Chinese Academy of Sciences

    Ningbo,
    China

    Site Not Available

  • Changhai Hospital of Shanghai

    Shanghai,
    China

    Site Not Available

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an,
    China

    Site Not Available

  • Qinghai Province People's Hospital

    Xining,
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou,
    China

    Site Not Available

  • Zigong Fourth People's Hospital

    Zigong,
    China

    Site Not Available

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