To construct a physiological based pharmacokinetic model to predict and validate the plasma concentration of rivaroxaban in adult patients with liver cirrhosis

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2300073784

Enrollment

Unknown

Registered

2023-07-20

Start date

2023-07-19

Completion date

Unknown

Last updated

2023-07-25

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

Conditions

Cirrhosis

Interventions

Case series:None

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: ? Age 18-70 years old, gender unlimited; ?Cirrhosis, CTP grade A, B or C, the etiology is not limited; ? The cause of anticoagulation was PVT formation or post-TIPS; ? Application of rivaroxaban (Suzhou Third Pharmaceutical Co., LTD., Sinopol H20213398) ; ? Sign informed consent.

Exclusion criteria

Exclusion criteria: ? History of liver cancer or other systemic malignancies; ? History of cerebral hemorrhage and active hemorrhage; ? A history of smoking (average smoking of 5 or more cigarettes per day), alcohol abuse (14 units of alcohol per week: 1 unit = 285ml of beer, or 25ml of spirits, or about 100ml of wine) or drug abuse, or who could not guarantee that they would not smoke or drink during the trial period; ? There are other factors that the investigator considers unsuitable for participation in the trial.

Design outcomes

Primary

Measure	Time frame
plasma concentration;	—

Countries

China

Contacts

Public ContactMin Jia

Beijing You 'an Hospital, Capital Medical University

348059065@qq.com+86 134 6664 5710

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 26, 2026