UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026426
Receipt number R000030283
Scientific Title A Study on predictors of treatment response concerning of the efficacy of tolvaptan on refractory ascites.
Date of disclosure of the study information 2017/03/07
Last modified on 2023/07/12 18:25:40

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Basic information

Public title

A Study on predictors of treatment response concerning of the efficacy of tolvaptan on refractory ascites.

Acronym

Effect of tolvaptan on refractory ascites.

Scientific Title

A Study on predictors of treatment response concerning of the efficacy of tolvaptan on refractory ascites.

Scientific Title:Acronym

Effect of tolvaptan on refractory ascites.

Region

Japan


Condition

Condition

Liver cirrhosis with refractory ascites.

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To elucidate the parameters concerning for the efficacy of tolvaptan, competitive vasopressin receptor 2 antagonist, for cirrhotic patients with refractory ascites.

Basic objectives2

Others

Basic objectives -Others

Identification of the parameters affecting therapeutic effect of tolvaptan.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Over 1.5kg decrease of body weight.

Key secondary outcomes

Increase of urine volume.
Improvement of physical symptom.
Improvement of patient's symptom by using questionnaire (ASI-7 and CLD-Q).


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Administration of tolvaptan (7.5mg/day) for a refractory ascites patients.

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Patients over 20 years old
2)Patients obtained written informed consent
3) Life expectancy of at least 4 weeks
4) Adequate organ function
a) Hb>= 8.0g/dL
b) neutrophil: >= 1,500/mm3
c) Platelet: >= 30,000/mm3
d) Total bilirubin:< 4.0 mg/dL
e) ALT and AST: <= within 6 folds of normal limit
f) Serum creatine: <= 2.0 mg/dL
g) Serum natrium: >= 120mEq/L

Key exclusion criteria

1) Adequate cardiac organ function
a) Patients with conjestive heart failure above NYHA class3
b) Patients with severe hypertension
2) Patients with severe and active infectious disease (exclude HBV,HCV hepatitis)
3) Patients with HIV
4) Patients taking dialysis
5) Patients with portal tumor thrombosis (Vp3 or Vp4)
6) Patients with hepatic encephalopathy
7) Patients with crutial digestive bleedings within 4 weeks
8) Patients with the following treatment
a) Systemic chemotherapy
b) Being treated with invasive surgical therapy within 4 weeks
9) Patients with oral intake difficulty
10)Patients with severe digestive diseases
11)Patients taking a tablet which would affect this clinical study
12)Pregnant woman, lactating woman, or a woman suspected of pregnancy
13)Patients with severe allergic reaction to Tolvaptan
14)Patients with drug abuse or psychological disorders
15) Patients concluded to be inappropriate to participate in this study by their physicians

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Hideto
Middle name
Last name Kawaratani

Organization

Nara Medical University

Division name

The third department of internal medicine

Zip code

634-8522

Address

840 Shijo-cho Kashihara, Nara

TEL

0744-22-3051

Email

kawara@naramed-u.ac.jp


Public contact

Name of contact person

1st name Hideto
Middle name
Last name Kawaratani

Organization

Nara Medical University

Division name

The third department of internal medicine

Zip code

634-8522

Address

840 Shijo-cho Kashihara, Nara

TEL

0744-22-3051

Homepage URL


Email

kawara@naramed-u.ac.jp


Sponsor or person

Institute

The third department of internal medicine, Nara Medical University

Institute

Department

Personal name



Funding Source

Organization

The third department of internal medicine, Nara Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

IRB of Nara Medical University

Address

840 Shijo-cho Kashihara, Nara

Tel

0744-22-3051

Email

ino_rinri@naramed-u.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

研究協力施設


Other administrative information

Date of disclosure of the study information

2017 Year 03 Month 07 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

30

Results

Not available

Results date posted

2023 Year 07 Month 12 Day

Results Delayed

Delay expected

Results Delay Reason

Due to small number

Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2017 Year 01 Month 01 Day

Date of IRB

2017 Year 07 Month 12 Day

Anticipated trial start date

2017 Year 01 Month 01 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry

2023 Year 03 Month 31 Day

Date trial data considered complete

2023 Year 03 Month 31 Day

Date analysis concluded

2023 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2017 Year 03 Month 06 Day

Last modified on

2023 Year 07 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030283


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name