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The safety and efficacy of tauroursodeoxycholic acid as adjuvant treatment after liver transplantation: an open labelled study (TailStudy)

The safety and efficacy of tauroursodeoxycholic acid as adjuvant treatment after liver transplantation: an open labelled, prospective, randomized and controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-11001308
Enrollment
Unknown
Registered
2011-04-16
Start date
2011-05-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Chronic liver diseases and liver cirrhosis

Interventions

TUDCA group:TUDCA 250mg po Bid
Control group:No TUDCA

Sponsors

Guangdong Province Sci-tech Department
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. The informed consent signed; 2. Aged 18-65 years old; 3. Non-heart beating liver transplant recipients

Exclusion criteria

Exclusion criteria: 1. Pregnant or breast-feeding women; 2. Severe cardiac or renal dysfunction; 3. Severe endocrinological, hematic or mental diseases; 4. Acute gastric or duodenal ulcer; 5. ABO blood type incompatibility; 6. Cold ischemia time of allograft longer than 12 hours or warm ischemia time longer than 15 mins; 7. Death due to known reason within one week post-tranplantation; 8. Follow-up not conducted in the institute of transplantation.

Design outcomes

Primary

MeasureTime frame
biliary complications, such as bile leakage, bile duct stricture and biliary sludge;acute rejection episodes;allograft loss;early allograft dysfunction;death of recipients;

Secondary

MeasureTime frame
The time for Tbil, GGT and ALP to drop within normal range and the range of dropping in one month po;The time for AST and ALT to drop within normal range and the range of dropping in one month post-tra;

Countries

China

Contacts

Public ContactXiaoshun HE
gdtrc@163.com+86 13802510799

Outcome results

None listed

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