JPRN-UMIN000011666
Recruiting
未知
Peginterferon or conventional interferon sequential entecavir treatment for hepatitis B e antigen positive chronic hepatitis B patients: a prospective randomized controlled trial - Peginterferon or conventional interferon sequential entecavir treatment
Conditionschronic hepatitis B
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- chronic hepatitis B
- Sponsor
- Toranomon Hospital
- Enrollment
- 100
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1\. Prior exposure of interferon, antiviral agents, antitumoral agents, immunosupressive drugs, and radiotherapy within 6 months 2\. HCV RNA positivity 3\. Complicating other liver disease 4\. The diagnosis of Liver cirrhosis, hepatic failure, and liver cancer 5\. The history of hepatic encephalopathy, varices bleeding, and ascites 6\. Complicating collagen disease 7\. The history of interstitial pneumonia 8\. Severe heart disease 9\. The history of epilepsy 10\. The history of depression 11\. The history of abnormal thyroid function 12\. The history of stroke 13\. Severe diabetes 14\. The history of malignant tumor within 5 years 15\. The history of liver, kidney or bone marrow transplantation 16\. Retinopathy 17\. blood test abnormality as follows: (a) neutrophil \< 1,500 /mm3 (b) platelets count \< 90,000/ mm3 (c) Hb \< 10 g/dL (d) prothrombin time \> 20s or \< 60% (e) ALT \> 10 times ULN (f) total bilirubin \> 2\.0 mg/dL (g) albmin \< 3\.2 g/dL (h) creatinine clearance \< 50 mL/min 18\. Pregnancy 19\. Doctors condider inadequate
Outcomes
Primary Outcomes
Not specified
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COMBINED THERAPY WITH PEG-INTERFERON-a, RIBAVIRIN AND RITUXIMAB OF HEPATITIS C VIRUS-RELATED MIXED CRYOGLOBULINEMIA - NDpatients anti-HCV, HCV RNA positivity, Na?ve, with cryoglobulinemic vasculitis (detection of serum cryoglobulins associated with purpura, arthralgias and weakness)and with chronic hepatitisMedDRA version: 9.1Level: SOCClassification code 10005329EUCTR2010-020659-30-ITAZIENDA OSPEDALIERA OSPEDALE POLICLINICO CONSORZIALE