Phase III Study of Tolvaptan Tablet to Treat Cirrhosis Ascites

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy and safety of Tolvaptan 7.5mg and 15mg in treatment of patients with cirrhosis ascites who fail to response adequately to treatment with common diuretics.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Beijing Research Institute
• Treatments: Tolvaptan

Criteria

Inclusion criteria:

1. Patients diagnosed with liver cirrhosis clinically or pathologically;

2. Patients with ascites confirmed by Type-B ultrasound scan after receiving combination therapies of oral loop diuretics and aldosterone antagonists for at least 4 days with the fixed usage and dosage

3. Inpatients or patients who can be hospitalized for this study from Day -3 (Screening) to Day 8 (the day for efficacy evaluation);

4. Patients with body weight change within ±1.0 kg in the 2 days prior to initiation of treatment (Day -2 and Day -1)

5. Age: 18 to 75 years, inclusive(at the time informed consent is obtained);

6. Genders: men or women;

7. Patients who have signed informed consent form.

Exclusion criteria:

1. Patients with any of the following diseases, complications or symptoms:

• Hepatic encephalopathy (hepatic coma of grade II or higher1）);

• Malignant ascites (patients have tumor cells detected in ascites if malignant ascites be highly suspected);

• Uncontrolled spontaneous bacterial peritonitis;

• Patients who are likely to experience alimentary tract hemorrhage during the study;

• Heart failure (NYHA2） grade III or IV);

• Anuresis (daily urine volume is less than 100mL);

• Dysuria due to urinary tract stricture, urinary calculus, tumor in the urinary tract or other cause.

2. Patients with history of :

• Alimentary tract hemorrhage within 10 days prior to screening;

• Cerebral accident suffered within 30 days prior to screening;

• Past history of hypersensitivity or idiosyncratic reaction to benzazepine derivatives (Benazepril).

3. Patients with systolic pressure below 90mmHg at screening;

4. Patients with any of the following abnormal laboratory parameters at screening:

• Serum creatinine >1.5x upper limit of normal range;

• Serum Na+>145mmol/L (or higher than upper limit of normal range);

• Serum K+>5.5mmol/L;

5. Patients with Child-pugh score3）>12;

6. Patients who are unable to take medicine orally;

7. Female patients who are pregnant, lactating, or who are at child-bearing age without using acceptable contraceptive means;

8. Patients who received blood products including albumin within 4 days prior to the initiation of treatment

9. Patients who participated in any clinical trial other than tolvaptan within one month prior to screening;

10. Patients who participated in Tolvaptan trials and took Tolvaptan previously;

11. Patients otherwise judged by the investigator, to be inappropriate for inclusion in the study.