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Dose Exploring and Setting Study for Tolvaptan to Treat Hepatic Cirrhosis With Ascites

Primary Purpose

Ascites, Hepatic Cirrhosis

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tolvaptan
Tolvaptan
placebo
Sponsored by
Otsuka Beijing Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ascites

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. hepatic cirrhosis patients after 7days treatment of loop diuretics and aldosterone antagonist but still with ascites
  2. Hospitalized patients or those who can be hospitalized in this trial between observation period and posttherapeutic observation (Visits at clinic will be allowed after day 8);
  3. During the observation period (-3 day to -1 day ), subjects whose body weight difference fall within ±1.0 kg range 2 days (day-2 and day -1) prior to initiation of trial drug treatment;
  4. Ages: ≥18 and ≤75 years of age;
  5. Genders: men or women;
  6. Signed the Informed Consent Form.

Exclusion Criteria:

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

    • Hepatic encephalopathy (Coma scale Note 1) grade 2 or higher);
    • Malignant ascites;
    • Uncontrolled spontaneous bacterial peritonitis;
    • Patients are likely to experience alimentary tract hemorrhage during the trial;
    • Heart failure (NYHA cardiac function scale Note 2) stages 3 and 4);
    • Anuria (daily urine volume below 100mL);
    • Dysuria resulting from urethral stricture, calculus and tumors.

  2. Patients with the following medical history:

    • Alimentary tract hemorrhage within 10 days prior to screening;
    • Cerebrovascular accident within 1 month prior to screening;
    • Gout attack within 1 month prior to screening;
    • Past allergy or hypersensitive reactions to benzodiazepines (e.g. benazepril hydrochloride)
  3. Systolic pressure below 90mmHg at screening;

  4. Patients with the following abnormalities in laboratory examinations at screening:

    Serum creatinine exceeds 2.5X upper limits of normal, serum Na+>145mmol/L (or exceeds upper limits of normal), serum K+>5.5mmol/L, uric acid>8.0mg/dL (476μmol/L), Child-pugh scale greater than 12.

  5. Patients cannot take drugs orally;
  6. Pregnant or breast-feeding patients or women at child-bearing ages without taking acceptable contraceptive measures;
  7. Patients received albumin or other blood preparations within 4 days prior to trial drug administration;
  8. Patients participated in clinical trials of other drugs within 1 month prior to screening;
  9. Patients participated in tolvaptan trials and took tolvaptan previously;
  10. Patients are unsuitable to participate in this trial in investigators' opinion.

Sites / Locations

  • Renji hospital, Shanghai Jiaotong University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

1. tolvaptan

2 tolvaptan

3. Placebo

Arm Description

15 mg, P.O., Qd, for 7 days,

30 mg, P.O., Qd, for 7 days,

30mg,P.O.,Qd, for 7 days.

Outcomes

Primary Outcome Measures

Body weight changes after 7 days of treatment (quantity of changes)

Secondary Outcome Measures

Body weight change after 4 days of treatment (quantity of changes)
Waist circumference after 4 and 7 days of treatment (quantity and rate of changes)

Full Information

First Posted
March 5, 2010
Last Updated
October 10, 2012
Sponsor
Otsuka Beijing Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01349335
Brief Title
Dose Exploring and Setting Study for Tolvaptan to Treat Hepatic Cirrhosis With Ascites
Official Title
A Phase 2 Randomized, Double-blinded, Multicenter and Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of Different Doses of Tolvaptan Tablet in Patients With Cirrhotic Ascites
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Beijing Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To observe the safety/efficacy of tolvaptan for treatment of patients with hepatic cirrhosis with ascites and exploring the dosage-effect relations of the drug.
Detailed Description
Tolvaptan is able to exert hydragogue diuretic effects (water diuresis) via inhibition of water reabsorption by renal collecting ducts without corresponding increase in electrolyte excretion. It has been confirmed that tolvaptan is able to increase urine volume without any adverse effects on renal functions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ascites, Hepatic Cirrhosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1. tolvaptan
Arm Type
Experimental
Arm Description
15 mg, P.O., Qd, for 7 days,
Arm Title
2 tolvaptan
Arm Type
Experimental
Arm Description
30 mg, P.O., Qd, for 7 days,
Arm Title
3. Placebo
Arm Type
Experimental
Arm Description
30mg,P.O.,Qd, for 7 days.
Intervention Type
Drug
Intervention Name(s)
Tolvaptan
Other Intervention Name(s)
SAMSCA
Intervention Description
tablet, 15 mg, Qd, for 7 days
Intervention Type
Drug
Intervention Name(s)
Tolvaptan
Other Intervention Name(s)
SAMSCA
Intervention Description
tablet, 30 mg, Qd, 7 days
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
blank tablet
Intervention Description
tablet, 30 mg, Qd, 7days.
Primary Outcome Measure Information:
Title
Body weight changes after 7 days of treatment (quantity of changes)
Time Frame
from day1 to day7
Secondary Outcome Measure Information:
Title
Body weight change after 4 days of treatment (quantity of changes)
Time Frame
from day1 to day4
Title
Waist circumference after 4 and 7 days of treatment (quantity and rate of changes)
Time Frame
from day1 to day7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: hepatic cirrhosis patients after 7days treatment of loop diuretics and aldosterone antagonist but still with ascites Hospitalized patients or those who can be hospitalized in this trial between observation period and posttherapeutic observation (Visits at clinic will be allowed after day 8); During the observation period (-3 day to -1 day ), subjects whose body weight difference fall within ±1.0 kg range 2 days (day-2 and day -1) prior to initiation of trial drug treatment; Ages: ≥18 and ≤75 years of age; Genders: men or women; Signed the Informed Consent Form. Exclusion Criteria: Patients with the following diseases, complications or symptoms: Hepatic encephalopathy (Coma scale Note 1) grade 2 or higher); Malignant ascites; Uncontrolled spontaneous bacterial peritonitis; Patients are likely to experience alimentary tract hemorrhage during the trial; Heart failure (NYHA cardiac function scale Note 2) stages 3 and 4); Anuria (daily urine volume below 100mL); Dysuria resulting from urethral stricture, calculus and tumors. Patients with the following medical history: Alimentary tract hemorrhage within 10 days prior to screening; Cerebrovascular accident within 1 month prior to screening; Gout attack within 1 month prior to screening; Past allergy or hypersensitive reactions to benzodiazepines (e.g. benazepril hydrochloride) Systolic pressure below 90mmHg at screening; Patients with the following abnormalities in laboratory examinations at screening: Serum creatinine exceeds 2.5X upper limits of normal, serum Na+>145mmol/L (or exceeds upper limits of normal), serum K+>5.5mmol/L, uric acid>8.0mg/dL (476μmol/L), Child-pugh scale greater than 12. Patients cannot take drugs orally; Pregnant or breast-feeding patients or women at child-bearing ages without taking acceptable contraceptive measures; Patients received albumin or other blood preparations within 4 days prior to trial drug administration; Patients participated in clinical trials of other drugs within 1 month prior to screening; Patients participated in tolvaptan trials and took tolvaptan previously; Patients are unsuitable to participate in this trial in investigators' opinion.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Minde Zeng
Organizational Affiliation
RenJi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Renji hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200001
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
30180806
Citation
Wang S, Zhang X, Han T, Xie W, Li Y, Ma H, Liebe R, Weng H, Ding HG. Tolvaptan treatment improves survival of cirrhotic patients with ascites and hyponatremia. BMC Gastroenterol. 2018 Sep 4;18(1):137. doi: 10.1186/s12876-018-0857-0.
Results Reference
derived

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Dose Exploring and Setting Study for Tolvaptan to Treat Hepatic Cirrhosis With Ascites

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