Status:
RECRUITING
Efficacy and Safety of Upatinib in the Treatment of Active Anal Fistulas in Crohn's Disease
Lead Sponsor:
Sixth Affiliated Hospital, Sun Yat-sen University
Conditions:
Crohn's Diseases
Active Anal Fistula
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
Anal fistula is the most common perianal lesion of Crohn's disease (CD), and the incidence of anal fistula in eastern CD population is significantly higher than that in Western population. The treatme...
Detailed Description
Crohn's disease (CD) is a chronic non-specific inflammatory disease of the intestine, and anal fistula is the most common perianal lesion in CD. Active anal fistula refers to the infection of the fist...
Eligibility Criteria
Inclusion
- Age ≥18 years and ≤70 years;
- Make a clear diagnosis of CD according to the "Consensus Opinions on the Diagnosis and Treatment of Inflammatory Bowel Disease (Beijing, 2018)";
- The disease severity of CD was moderate and severe according to Crohn's diseaseactivityindex (CDAI), that is, CDAI score \> 220.
- Complicated with active anal fistula, that is, on the basis of perianal MRI confirmation of anal fistula, the patient has perianal pain, fluid seepage and other symptoms, and the transanal surgeon judges that the symptoms are related to anal fistula activity;
- Patients with previous thrombosis, including deep vein thrombosis, pulmonary thromboembolism, atrial thrombosis, peripheral artery thrombosis and cerebral thrombosis confirmed by imaging;
- Informed consent. The subjects gave barrier-free informed consent, voluntarily participated in the clinical study and signed the informed consent.
Exclusion
- History of allergy to the active ingredient of upatinib;
- Severe damage of liver and kidney function; Hemoglobin \< 8g/L;
- History of malignant tumor;
- Patients with previous thrombosis;
- Neutrophil count \< 1×109/L; , or lymphocyte count \< 500×109/L;
- Patients with intestinal complications (including intestinal stricture with proximal intestinal dilation or intestinal fistula). Diagnosis based on CTE/MRE.
- Presence of enterostomy;
- With active severe infection (such as sepsis) or opportunistic infection (such as active tuberculosis, shingles);
- Pregnant or planning pregnancy.
- Patients with vaginal fistula;
- Patients with anorectal stenosis.
Key Trial Info
Start Date :
January 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT06902987
Start Date
January 17 2024
End Date
December 30 2026
Last Update
March 30 2025
Active Locations (1)
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1
Sixth afflicated of Sun-yat sen university
Guangzhou, Guangdong, China, 510000