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Azathiopurine-induced leukopenia and evaluation of therapeutic effects of Diyushengbai tablet in inflammatory bowel disease patients

Azathiopurine-induced leukopenia and evaluation of therapeutic effects of Diyushengbai tablet in inflammatory bowel disease patients

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078903
Enrollment
Unknown
Registered
2023-12-20
Start date
2021-07-01
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

inflammatory bowel disease

Interventions

Diyushengbai group:Diyushengbai tablet treatment
dose decreasing group:decrease azathiopurine dose

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1)Patients were diagnosed with inflammatory bowel disease; (2)Receive azathiopurine treatment for the first time; (3)Age over 18 years old and with capacity for civil acts; (4)receive genetic testing (TPMT*3C and NUDT15 R139C) and were identified as wild-types or heterozygotes; (5) Capable and willing to provide informed consent and comply with research requirements.

Exclusion criteria

Exclusion criteria: (1)Patients were identified as homozygotes for TPMT*3C or NUDT15 R139C; (2)Receive allopurinol and/or granulocyte colony-stimulating factor treatment simultaneously; (3)the base value of white blood cell count is below 3.0×10^9/L or absolute neutrophil count is below 1.5×10^9/L; (4)hepatic dysfunction; (5) renal dysfunction; (6)with rheumatic diseases, hepatitis, intestinal tuberculosis and malignant tumor; (7) Patients with severe diseases of important organs such as the heart, lungs, kidneys, brain, and blood; (8) Patients who have pregnancy plans and are unwilling to use contraception during the study period; (9)receive radiotherapy and chemotherapy within half a year; (10) Patients with abnormal mental behavior; (11) The researchers believe that patients who are not suitable to participate in this study; (12) Patients who participate in other clinical studies simultaneously.

Design outcomes

Primary

MeasureTime frame
white blood cell count ;clinical effective rate;clinical inefficient rate;the number of patients stopping take azathiopurine;the number of patients taking decreased azathiopurine;

Secondary

MeasureTime frame
white blood cell count ;erythrocyte sedimentation rate;C-reactive protein;liver function index;renal function index;Crohn's Disease Activity Index;ulcerative colitis Myao score;

Countries

China

Contacts

Public ContactHu Zhang

West China Hospital of Sichuan University

zhanghu@scu.edu.cn+86 189 8060 6217

Outcome results

None listed

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