NCT01349335

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2009

Shorter than P25 for phase_2

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

April 1, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2010

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

May 6, 2011

Completed
Last Updated

October 12, 2012

Status Verified

May 1, 2011

Enrollment Period

9 months

First QC Date

March 5, 2010

Last Update Submit

October 10, 2012

Conditions

AscitesHepatic Cirrhosis

Outcome Measures

Primary Outcomes (1)

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

    from day1 to day7

Secondary Outcomes (2)

  • Body weight change after 4 days of treatment (quantity of changes)

    from day1 to day4

  • Waist circumference after 4 and 7 days of treatment (quantity and rate of changes)

    from day1 to day7

Study Arms (3)

1. tolvaptan

EXPERIMENTAL

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

Drug: Tolvaptan

2 tolvaptan

EXPERIMENTAL

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

Drug: Tolvaptan

3. Placebo

EXPERIMENTAL

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

Drug: placebo

Interventions

TolvaptanDRUG

tablet, 15 mg, Qd, for 7 days

Also known as: SAMSCA
1. tolvaptan
placeboDRUG

tablet, 30 mg, Qd, 7days.

Also known as: blank tablet
3. Placebo

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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:
  • +7 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 (1)

  • 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 2
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

March 5, 2010

First Posted

May 6, 2011

Study Start

April 1, 2009

Primary Completion

January 1, 2010

Study Completion

April 1, 2010

Last Updated

October 12, 2012

Record last verified: 2011-05

Locations

CN(1)