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Evaluation of the Safety and Efficacy of PEDAC-UA Single-Use Hemoperfusion Device in the Hemoperfusion Treatment of Refractory Gout Patients: A Randomized, Open-Label, Multicenter, Add-On Therapy Clinical Trial

Evaluation of the Safety and Efficacy of PEDAC-UA Single-Use Hemoperfusion Device in the Hemoperfusion Treatment of Refractory Gout Patients: A Randomized, Open-Label, Multicenter, Add-On Therapy Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103892
Enrollment
Unknown
Registered
2025-06-06
Start date
2023-09-21
Completion date
Unknown
Last updated
2025-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory Gout

Interventions

Control Group:Febuxostat 20mg qd po
Experimental Group:Oral febuxostat 20 mg/day Hemoperfusion once a week for three weeks

Sponsors

The Affiliated Hospital of Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Male or female, 18 years old=360µmol/L; (2) Gout attacks >=2 times/year despite standardized treatment; (3) patients with multiple and/or progressive tophi); 3. Patients with serum uric acid >=480 µmol/L 2 weeks after elution; 4. Presence of at least one tophi detectable by imaging examination; 5. Subjects voluntarily participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with hyperuricemia secondary to other diseases, such as blood diseases (including leukemia, multiple myeloma or other malignant tumors), chronic poisoning, increased blood uric acid production caused by chronic kidney disease, or disorders of uric acid excretion; 2. Those who are expected to undergo tophi surgery during the study period or need to use other blood purification treatments at the same time; 3. Patients with coagulation dysfunction, severe bleeding tendency (PT value greater than the upper limit of normal value for more than 6s and accompanied by bleeding, or APTT value greater than 1.5 times of the upper limit of normal value and accompanied by bleeding; 4. Those who have a history of allergy to heparin, sodium citrate, colchicine, febuxostat, plasma separator, membrane or tubing of adsorption column; 5. Receiving imidazothioprine, azathioprine, chophylline, mercaptopurine, or thiazide diuretics, and need to continue to use during the trial; 6. Those with severe liver impairment (Child-Pugh grade C) or accompanied by bone marrow insufficiency; 7. Severe active hemorrhage or systemic circulatory failure that is difficult to correct with DIC or drugs, cardiac or cerebral infarction in unstable period, intracranial hemorrhage or severe cerebral edema with cerebral herniation, mental disorder and unable to cooperate with treatment, etc.; 8. Pregnant or lactating females; 9. Those who have participated in any drug clinical trial within 3 months before screening, or have participated in a medical device clinical trial within 1 month; 10. Any other reasons that the investigator believes may affect the efficacy and/or safety evaluation of this study and are not suitable for participating in this clinical trial (including but not limited to those who are judged by the investigator to have poor compliance with the subject, or live far away and cannot be followed up on schedule).

Design outcomes

Primary

MeasureTime frame
Uric Acid;

Secondary

MeasureTime frame
Tophi volume;

Countries

China

Contacts

Public ContactLi Changgui

The Affiliated Hospital of Qingdao University

lichanggui@medmail.com.cn+86 166 7863 7856

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026