Condition: Primary Biliary Cholangitis · Sponsor: Xijing Hospital of Digestive Diseases
Current treatment guidelines recommend ursodeoxycholic acid (UDCA) as the first-line treatment for new-diagnosed primary biliary cholangitis (PBC) patients. However, up to 40% patients are insensitive to UDCA monotherapy, and evaluation of UDCA response at 12 months may result in long period of ineffective treatment. We aimed to develop a new criterion to reliably identify non-response patients much earlier. Recently, our team designed and validated a new early criterion for distinguishing high-risk PBC patients in a Chinese population for the first time. Our data indicated that PBC patients with ALP ≤ 2.5 × ULN, AST ≤ 2 × ULN, and TBIL ≤ 1 × ULN (Xi'an criterion) after 1 month UDCA treatment were likely to have better prognosis. It can be readily applied in the rapid identification of PBC patients who require additional therapeutic approaches. However, whether it is reasonable to apply it to the response definition of clinical research, and the guidance of PBC management and choice of second-line treatment, further research is needed.
This description comes directly from the study's public registry record.
Yulong Shang · +86 18629661032 · shangyl870222@163.com
Ying Han · +86-29-84771539 · hanying1@fmmu.edu.cn
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| The second hospital of Lanzhou University | Lanzhou, Gansu, China | Recruiting |
| Sun Yat-sen Memorial Hospital | Guangzhou, Guangdong, China | Not Yet Recruiting |
| Nanjing Drum Tower Hospital | Nanjing, Jiangsu, China | Recruiting |
| The First Hospital of China Medical University | Shenyang, Liaoning, China | Recruiting |
| Ying han | Xi'an, Shaanxi, China | Recruiting |
| Sichuan Provincial People's Hospital, | Chengdu, Sichuan, China | Recruiting |
| Tianjin Medical University General Hospital | Tianjin, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05751967