NCT01349348

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
535

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

October 12, 2012

Status Verified

October 1, 2012

Enrollment Period

1.6 years

First QC Date

May 4, 2011

Last Update Submit

October 10, 2012

Conditions

AscitesHepatic Cirrhosis

Keywords

Tolvaptan treatment to ascites and hepatic cirrhosis

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in body weight after 7 days randomized treatment (Day 8).

    7 days

Secondary Outcomes (2)

  • Change from baseline in body weight after 4 days randomized treatment (Day 5);

    4days

  • The rate of change from baseline in body weight after 4, 7 days randomized treatment (Day 5, Day 8);

    4 and 7 days

Study Arms (3)

Tolvaptan 15mg

EXPERIMENTAL

Tablet;15mg/tab

Drug: Tolvaptan

Tolvaptan 7.5mg

EXPERIMENTAL

Tablet;7.5mg/tab

Drug: Tolvaptan

Placebo

PLACEBO COMPARATOR

Tolvaptan 0mg/tab

Drug: placebo

Interventions

TolvaptanDRUG

tablet, 15 mg, Qd, for 7 days

Also known as: SAMSCA
Tolvaptan 15mg
placeboDRUG

tablet, 7.5/15mg , Qd, 7days.

Also known as: Blank tablet
Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with liver cirrhosis clinically or pathologically;
  • 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
  • Inpatients or patients who can be hospitalized for this study from Day -3 (Screening) to Day 8 (the day for efficacy evaluation);
  • Patients with body weight change within ±1.0 kg in the 2 days prior to initiation of treatment (Day -2 and Day -1)
  • Age: 18 to 75 years, inclusive(at the time informed consent is obtained);
  • Genders: men or women;
  • Patients who have signed informed consent form.

You may not qualify if:

  • 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.
  • 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).
  • Patients with systolic pressure below 90mmHg at screening;
  • Patients with any of the following abnormal laboratory parameters at screening:
  • Serum creatinine \>1.5x upper limit of normal range;
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200001, China

Location

Related Publications (2)

  • Tang J, Wang Y, Han T, Mao Q, Cheng J, Ding H, Shang J, Zhang Q, Niu J, Ji F, Chen C, Jia J, Jiang X, Lv N, Gao Y, Wang Z, Wei Z, Chen Y, Zeng M, Mao Y. Tolvaptan therapy of Chinese cirrhotic patients with ascites after insufficient diuretic routine medication responses: a phase III clinical trial. BMC Gastroenterol. 2020 Nov 19;20(1):391. doi: 10.1186/s12876-020-01536-0.

    PMID: 33213378DERIVED

  • 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.

    PMID: 30180806DERIVED

MeSH Terms

Conditions

AscitesLiver Cirrhosis

Interventions

Tolvaptan

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLiver DiseasesDigestive System DiseasesFibrosis

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Minde Zeng

    RenJi Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2011

First Posted

May 6, 2011

Study Start

October 1, 2010

Primary Completion

May 1, 2012

Study Completion

July 1, 2012

Last Updated

October 12, 2012

Record last verified: 2012-10

Locations

CN(1)