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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	JPRN
Last refreshed on:	17 October 2023
Main ID:	JPRN-UMIN000003363
Date of registration:	25/03/2010
Prospective Registration:	No
Primary sponsor:	Dokkyo Medical University
Public title:	Preventive effect on recurrence of hepatocellular carcinoma by branched chain amino acids after curative hepatectomy
Scientific title:	Preventive effect on recurrence of hepatocellular carcinoma by branched chain amino acids after curative hepatectomy - Prevention of HCC-recurrence by branched chain amino acids after hepatectomy
Date of first enrolment:	2010/02/01
Target sample size:	140
Recruitment status:	Recruiting
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004088
Study type:	Interventional
Study design:	Parallel Randomized
Phase:	Phase III

Countries of recruitment
Japan

Contacts

Name:	Keiichi Kubota
Address:	Kitakobayashi 880, Mibu, Shimotsuga, Tochigi Japan
Telephone:	0282-86-1111
Email:
Affiliation:	Dokkyo Medical University Second Department of Surgery

Name:	Tokihiko Sawada
Address:	Kitakobayashi 880, Mibu, Shimotsuga, Tochigi Japan
Telephone:	0282-86-1111
Email:	tsawada@dokkyomed.ac.jp
Affiliation:	Dokkyo Medical University Second Department of Surgery

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: 1)recurrence of hepatocellular carcinoma 2)Stage IV 3)Patients who were given branched chain amino acid within 4 weeks of regisration 4)hepatic coma>III 5)serum bilirubin level more than 3.0 mg/dL 6)Congenital abnormality of branched chain amino acids- metabolism

Age minimum: Not applicable
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

hepatocellular carcinoma

Intervention(s)

Intervention:term 4 years dose Reevact 4g/time frequency 3 times/day
Control 1:term 4 years no drug

Primary Outcome(s)

disease-free suravival rate

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

Dokkyo Medical University

Secondary Sponsor(s)

Ethics review

Status: YES
Approval date:
Contact:

Results

Results available:	Yes
Date Posted:
Date Completed:	01/12/2014
URL:

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