Unique ID issued by UMIN | UMIN000021768 |
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Receipt number | R000025076 |
Scientific Title | A multicenter open-label randomized controlled trial comparing interferon-nucleoside/nucleotide analogues add-on therapy with interferon-nucleoside/nucleotide analogues sequential therapy for chronic hepatitis B. |
Date of disclosure of the study information | 2016/04/06 |
Last modified on | 2019/03/19 23:52:03 |
A multicenter open-label randomized controlled trial comparing interferon-nucleoside/nucleotide analogues add-on therapy with interferon-nucleoside/nucleotide analogues sequential therapy for chronic hepatitis B.
Interferon-nucleoside/nucleotide analogues add-on and sequential therapy for chronic hepatitis B: a randomized controlled trial
A multicenter open-label randomized controlled trial comparing interferon-nucleoside/nucleotide analogues add-on therapy with interferon-nucleoside/nucleotide analogues sequential therapy for chronic hepatitis B.
Interferon-nucleoside/nucleotide analogues add-on and sequential therapy for chronic hepatitis B: a randomized controlled trial
Japan |
chronic hepatitis B
Hepato-biliary-pancreatic medicine |
Others
NO
The aim of this study is to clarify whether peginterferon alpha-2a-nucleoside/nucleotide analogues add-on therapy is superior to peginterferon alpha-2a-nucleoside/nucleotide analogues sequential therapy in chronic hepatitis B patients who currently take nucleoside/nucleotide analogues.
Efficacy
Exploratory
Pragmatic
Phase IV
The number of patients who achieve > 0.5 logU/ml reduction of HBsAg after 24 and 48 weeks.
(1)Change of ALT
(2)Change of HBeAg
(3)HBV-specific immunological reactions
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 |
Peginterferon-nucleoside/nucleotide analogues sequential therapy arm:For patients who take nucleoside/nucleotide analogues orally, 90 to 180ug of PEG-IFN alpha-2a is administered subcutaneously once a week for 48 weeks. Nucleoside/nucleotide analogues will be quitted 4 weeks after starting PEG-IFN alpha-2a.
Peginterferon-nucleoside/nucleotide analogues add-on therapy arm:For patients who take nucleoside/nucleotide analogues orally, 90 to 180ug of PEG-IFN alpha-2a is administered subcutaneously once a week for 48 weeks. Nucleoside/nucleotide analogues will be continued through 48 weeks.
20 | years-old | <= |
Not applicable |
Male and Female
(1) Chronic hepatitis B patients who take nucleoside/nucleotide analogues at least for three months.
(2) Chronic hepatitis patients without advanced liver fibrosis (up tp F2).
(3) Patients who well understand the risk of exacerbation of hepatitis after stopping nucleoside/nucleotide analogues and can be closely watched.
(1)The patients who are prescribed with Sho-saiko-toh. (2)The patients who had or have interstitial pneumonia. (3)The patients with autoimmune hepatitis. (4)The patients who have an allergy against interferon and other medications in the study. (5)The patients who have allergy against vaccine or other biologics. (6)The patients with a severe mental disease such as depression, a suicide consideration, or suicide project, or the past history of such conditions. (7)The patients with liver cirrhosis or severe hepatic diseases. (8)The patients with untreated hepatic cancers. (9)The patients who were judged inappropriate for the study by the doctor.
60
1st name | |
Middle name | |
Last name | Shinichi Asabe |
Saitama Medical Center, Jichi Medical University
Department of Gastroenterology
1-847 Amanuma-cho, Omiya-ku, Saitama-shi, Saitama
048-647-2111
jmukanzo@gmail.com
1st name | |
Middle name | |
Last name | Shinichi Asabe |
Saitama Medical Center, Jichi Medical University
Department of Gastroenterology
1-847 Amanuma-cho, Omiya-ku, Saitama-shi, Saitama
048-647-2111
jmukanzo@gmail.com
Department of Gastroenterology,Saitama Medical Center, Jichi Medical University
none
Self funding
none
NO
2016 | Year | 04 | Month | 06 | Day |
Unpublished
Terminated
2016 | Year | 04 | Month | 04 | Day |
2016 | Year | 04 | Month | 01 | Day |
2016 | Year | 04 | Month | 04 | Day |
2018 | Year | 12 | Month | 31 | Day |
2018 | Year | 12 | Month | 31 | Day |
2016 | Year | 04 | Month | 04 | Day |
2019 | Year | 03 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025076
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