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NCT07149675
PBC Long-term Outcomes Study
trial in Primary Biliary Cholangitis (PBC) in 4,000 participants. Currently enrolling.
31 December 2029
Quick facts
| Lead sponsor | Beijing Friendship Hospital |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 4,000 |
| Start date | 18 May 2025 |
| Primary completion | 31 December 2029 |
| Estimated completion | 31 December 2029 |
| Sites | 1 location across China |
Conditions studied
- Primary Biliary Cholangitis (PBC) — all drugs for Primary Biliary Cholangitis (PBC) →
- Long-term Outcomes — all drugs for Long-term Outcomes →
- Prognosis — all drugs for Prognosis →
- Multicenter Prospective Study — all drugs for Multicenter Prospective Study →
Sponsor
Beijing Friendship Hospital
Who can join
Eligibility, any sex, with Primary Biliary Cholangitis (PBC) or Long-term Outcomes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Primary biliary cholangitis (PBC) is an autoimmune liver disease predominantly affecting middle-aged women. While historically it was deemed rare, advancements in specific auto-antibody tests have led to increased recognition of PBC. The long-term survival of PBC patients in China is not yet fully understood. Several studies have investigated the prognosis of PBC in China. While these studies provide valuable insights into the disease characteristics and prognostic factors of PBC in China, they are all single-center studies with limitations. They lack consideration of the impact of symptoms, varying disease stages, and second-line treatments on prognosis. Therefore, there is a pressing need for multicenter and large-scale studies to further elucidate the characteristics and long-term survival of PBC patients in China. Biochemical response to ursodeoxycholic acid (UDCA) is an independent factor associated with long-term survival. Unfortunately, approximately 30-40% of PBC patients demonstrate insufficient biochemical response to UDCA. In our cohort, we reported a higher nonresponse rate, with about 44% according to the Paris I criteria. These patients remain at risk for disease progression to advanced stages and may benefit from additional second-line drug therapies. With significant advancements in the development of new drugs for PBC, a comprehensive understanding of patients with suboptimal responses to UDCA-including long-term prognosis, the distribution of different disease stages, and the prevalence of pruritus-will provide a basis for individualized treatment strategies. Additionally, fatigue and pruritus are prevalent symptoms for PBC patients and fluctuates independently of disease activity or stage, which significantly diminishing health-related quality of life. However, the incidence and impact of fatigue and pruritus on long-term outcomes for PBC patients in China need further clarification. Therefore, we would like to conduct this multicenter study to estimate the prevalence of PBC in China and to evaluate the symptomatic burden, treatment, and long-term outcomes among PBC patients in China.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07149675
- Europe PMC full search
- ASCO Meeting Library
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- bioRxiv preprints
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Related trials
Other recruiting trials for Primary Biliary Cholangitis (PBC)
Currently open trials in the same condition.
- NCT07449793 — Biochemical Response and Clinical Outcomes in Patients With PBC · recruiting
- NCT07296458 — FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy · Phase 3 · recruiting
- NCT07161245 — RELIEF: Multimodal Prehabilitation to Treat Fatigue in Patients With Primary Biliary Cholangitis · NA · recruiting
- NCT06016842 — A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis · Phase 3 · recruiting
- NCT05896124 — CS0159 in Chinese Patients With PBC (Primary Biliary Cholangitis) · Phase 2 · active not recruiting
Other Beijing Friendship Hospital trials
Trials by the same sponsor.
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- NCT07441850 — Digital Rehabilitation for Gastric Cancer Surgery After Neoadjuvant Therapy · NA · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07149675 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Beijing Friendship Hospital
- Last refreshed: 2 September 2025
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