liver cirrhosis
Conditions
Interventions
Test group:Tolvaptan tablets were taken orally 15mg daily for 7 days
Sponsors
Renji Hospital Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: above 18 years old and below 75 years old; 2. Gender: male or female; 3. Patients diagnosed cirrhosis with Child-Pugh grade B (score 7-9), accompanied by ascites is acceptable; 4. Sign informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients with the following diseases, complications or symptoms: · Hepatic encephalopathy (grade II or above, including grade II); · Cancerous ascites; · Spontaneous bacterial peritonitis; · Patients likely to have gastrointestinal bleeding during the trial; · Heart failure (NYHA functional class III and IV); · Anuria (urine output less than 100 mL per day); · Patients with difficulty in urination due to urinary tract stricture, stones, tumors, etc. (2) Patients with the following past medical history: · Patients with gastrointestinal bleeding within 10 days before screening; · Patients who have had a cerebrovascular accident within 1 month before screening; · Patients who have had gout attacks within 1 month before screening; · Patients who have had an allergic reaction or specific reaction to benzodiazepines (such as benazepril hydrochloride, etc.) in the past. (3) Patients with systolic blood pressure below 90 mmHg at the screening examination; (4) Patients with abnormal laboratory test values found at the screening examination: Serum creatinine more than 2.5 times the upper limit of normal, serum Na+ > 145 mmol/L (or above the upper limit of the normal range), serum K+ > 5.5 mmol/L, uric acid > 476 µmol/L, Child-Pugh score greater than 10 points. (5) Patients who cannot take oral medication; (6) Pregnant or lactating patients, and women of childbearing age who have not taken contraceptive measures; (7) Patients who have used blood products including albumin preparations within 4 days before taking the test drug; (8) Patients who have participated in other drug clinical trials within 1 month before screening; (9) Patients who have participated in tolvaptan drug clinical trials and taken tolvaptan in the past; (10) Patients judged by the investigator as unsuitable for participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration of DM-4103;Plasma concentration of DM-4107;Plasma concentration of Tolvaptan; | — |
Countries
China
Contacts
Public ContactMinde Zeng
Renji Hospital Shanghai Jiaotong University School of Medicine
Outcome results
None listed