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Clinical Trials/JPRN-UMIN000006659
JPRN-UMIN000006659
Recruiting
未知

Examination of efficacy and safety of PEG-IFN alpha-2a plus Adefovir dipivoxil for the treatment of chronic hepatitis B - PEG-IFN alpha-2a plus Adefovir therapy for chronic hepatitis B

Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine0 sites50 target enrollmentJanuary 4, 2012

Overview

Phase
未知
Intervention
Not specified
Conditions
chronic hepatitis B
Sponsor
Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine
Enrollment
50
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 4, 2012
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • 1\. Patient who is administering the sho\-sai\-ko\-to 2\. A patient with the previous history of interstitial pneumonia 3\. Other chronic liver disease patients such as autoimmune hepatitis or alcoholic hepatitis 4\. Patient who has previous history of hypersensitivity for element of PEG\-IFN alpha\-2a or other IFNs 5\. Patient who has previous history of hypersensitivity for biological products such as vaccines 6\. Patient with cirrhosis, liver failure, and liver carcinoma 7\. Hepatic encephalopathy, an esophageal varix, a patient with abdominal dropsy, or a patient with these previous history 8\. A patient with autoimmune diseases (hemolytic anemia, chronic ulcerative colitis, rheumatoid arthritis, etc.), or a patient with these anamneses 9\. Patient who has heart disease difficult to control (cardiac infarction, cardiac failure, and arrhythmia, etc.) 10\. Patient who exists in serious state of mental disease of serious depression, thought of suicide or suicide plan, etc. or with these history 11\. The patient of uncontrollable hypertension 12\. A patient with the past of apoplexy (cerebral infarction, cerebral hemorrhage, subarachnoid bleeding, transient ischemic attack) 13\. Pregnant woman or woman who has possibility of pregnancy or woman while suckling 14\. Additionally, patient judged by doctor that participation in this study is improper 15\. The patient who has the resistant to nucleic acid analog, such as Lamivudine and Entecavir

Outcomes

Primary Outcomes

Not specified

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