Unique ID issued by UMIN | UMIN000003763 |
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Receipt number | R000004213 |
Scientific Title | Effects of entecavir plus branched-chain amino acids versus entecavir alone in nucleoside-naïve Japanese adult patients with chronic hepatitis B virus infection : An open-label randomized controlled trial. |
Date of disclosure of the study information | 2010/06/16 |
Last modified on | 2013/06/27 09:07:09 |
Effects of entecavir plus branched-chain amino acids versus entecavir alone in nucleoside-naïve Japanese adult patients with chronic hepatitis B virus infection : An open-label randomized controlled trial.
Trial M
Effects of entecavir plus branched-chain amino acids versus entecavir alone in nucleoside-naïve Japanese adult patients with chronic hepatitis B virus infection : An open-label randomized controlled trial.
Trial M
Japan |
Chronic hepatitis B
Hepato-biliary-pancreatic medicine |
Others
NO
efficacy of entecavir plus branched-chain amino acids
Efficacy
Confirmatory
Phase III
the change from baseline in mean serum HBV-DNA level at week 12
the change from baseline in mean serum HBV-DNA level at week 4 and 8
the change from baseline in mean serum albumin level, ALT level, total bilirubin level and total cholesterol level at week 12
Safety (moniterd clinical and laboratory evaluation)
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
entecavir plus branched-chain amino acids
entecavir alone2
20 | years-old | <= |
Not applicable |
Male and Female
1) nucleoside-naïve Japanese adult patients with chronic hepatitis B virus infection
2)albumin level 4.0 g/dl or less
1) a history of allergy induced by nucleoside analog or exposure to nucleoside analogs
2) had a history of oral BCAA supplementation for 6 months or longer
3) Pregnant or lactating women and women who may be pregnant
4) had major complication of liver cirrhosis, such as HCC, variceal bleeding, hepatic encephalopathy or ascites requiring diuretics,
5) had other nonhepatic major diseases
6) Patients with other liver disease (e.g., hepatitis C virus, alchol)
7) Judged by investigator not to be appropriate for inclusion in this study
40
1st name | |
Middle name | |
Last name | Kazuaki Chayama |
graduate school of biomedical science, Hiroshima university.
Department and medicine and molecular science
1-2-3 kasumi, minami-ku, Hiroshima 734-8551
082-257-5190
1st name | |
Middle name | |
Last name | Yoshiiku Kawakami |
graduate school of biomedical science, Hiroshima university
Department and medicine and molecular science
1-2-3 kasumi, minami-ku, Hiroshima 734-8551
082-257-5190
Hiroshima liver study group
none
Self funding
NO
川上消化器内科クリニック、広島赤十字原爆病院、JA尾道総合病院、県立広島病院、呉医療センター、安佐市民病院、中国労災病院、広島鉄道病院、三次中央病院
2010 | Year | 06 | Month | 16 | Day |
Unpublished
Completed
2010 | Year | 03 | Month | 16 | Day |
2010 | Year | 05 | Month | 01 | Day |
2013 | Year | 03 | Month | 01 | Day |
2010 | Year | 06 | Month | 16 | Day |
2013 | Year | 06 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004213
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