Unique ID issued by UMIN | UMIN000008693 |
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Receipt number | R000010218 |
Scientific Title | PEG-IFN alpha 2a add-on therapy for chronic hepatitis B patients treated with Entecavir |
Date of disclosure of the study information | 2012/08/16 |
Last modified on | 2017/02/17 23:44:53 |
PEG-IFN alpha 2a add-on therapy for chronic hepatitis B patients treated with Entecavir
PEG-IFN add-on study for chronic hepatitis B
PEG-IFN alpha 2a add-on therapy for chronic hepatitis B patients treated with Entecavir
PEG-IFN add-on study for chronic hepatitis B
Japan |
Chronic hepatitis B
Hepato-biliary-pancreatic medicine |
Others
NO
To investigate the efficacy and safety of PEG-IFN alpha 2a add-on therapy for chronic hepatitis B patients who were treated with Entecavir
Safety,Efficacy
Rate of HBsAg <100IU/mL at 24 weeks after the end of treatment
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
PEG-IFN alpha 2a 90mcg, subcutaneous injection, once a week for 48 weeks
20 | years-old | <= |
Not applicable |
Male and Female
Patients with chronic hepatitis B treated with Entecavir, are fit with all criteria.
1) HBsAg >= 100IU/mL
2) Neutrophil counts >= 1500/mm3,
Platelet counts >= 70000/mm3,
Hemoglobin concentration >= 10g/dL
3) Written informed concent
1) Women of childbearing potential and pregnancy, lactating women
2) Concomitant herbal medication of Sho-saiko-to
3) History of interstitial pneumonia
4) Autoimmune hepatitis
5) Severe depression or psychosomatic disorders
6) Drug allegy against interferon
7) Allegic to vaccine or biological preperations
8) Other conditions considered inappropriate by attending physician
30
1st name | |
Middle name | |
Last name | Hideyuki Tamai |
Wakayama Medical University
Second department of internal medicine
811-1, Kimidera, Wakayama City
073-447-2300
tamahide@wakayama-med.ac.jp
1st name | |
Middle name | |
Last name | Hideyuki Tamai |
Wakayama Medical University
Second department of internal medicine
811-1, Kimidera, Wakayama City
073-447-2300
tamahide@wakayama-med.ac.jp
Wakayama Medical University
Wakayama Medical University
Self funding
NO
2012 | Year | 08 | Month | 16 | Day |
Partially published
One patient (6%) discontinued due to arrhythmia. HBe antigen disappearance was seen in 1 patient (25%). Although no HBs antigen disappearance occurred, HBs antigen levels decreased to less than 100 IU/mL in 4 patients (24%). The viral response rate was 59% (10/17). Adding low-dose PEG-IFN-alpha-2a to entecavir is safe. Log-reduction of the HBs antigen level at week 12 may become a useful predictor for viral response.
Completed
2012 | Year | 02 | Month | 23 | Day |
2012 | Year | 08 | Month | 16 | Day |
2016 | Year | 02 | Month | 16 | Day |
2016 | Year | 02 | Month | 16 | Day |
2016 | Year | 02 | Month | 16 | Day |
2016 | Year | 02 | Month | 16 | Day |
2012 | Year | 08 | Month | 15 | Day |
2017 | Year | 02 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010218
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