JPRN-UMIN000008289
Completed
Phase 2
Study of new therapy in patients with chronic hepatitis C including liver cirrhosis - Study of new therapy in patients with chronic hepatitis C including liver cirrhosis
niversity of Tsukuba0 sites10 target enrollmentJuly 2, 2012
Conditionschronic hepatitis C and liver cirrhosis
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- chronic hepatitis C and liver cirrhosis
- Sponsor
- niversity of Tsukuba
- Enrollment
- 10
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •(1\)Patient with acute hepatitis (2\)Patient with severe liver dysfunction whose serum liver function test is 5 fold higher than normal range, especially, AST or ALT is 2 fold higher than normal range (3\)HIV patient (4\)Patient with shunt from portal vein to inferior vena cava (5\)Serum total bilirubin concentration is more than 3\.0 mg/dl (6\)Past history of severe stroke or severe heart disease (7\)Bone marrow transplantation recipient or patients with immunodeficiency (8\)Patient with IgA or other plasma protein deficiency (9\)Patient with severe pulmonary, renal, gastroenterology, hematology or psycho\-neurologic disease (10\)Serum HbA1c concentration is more than 8\.0 (NGSP) (11\)Patient with hepatocellular carcinoma or another malignancy (12\)Woman with pregnancy or willing to get pregnant (13\)Patient who received platelet transfusion in previous 2 weeks (14\)Patient who are administered albumin preparation in previous 6 months (15\)Past history of splenectomy or partial splenic embolization (16\)Past history of drug allergies (17\)Past history of thromboembolism (18\)Patient whose doctor determined as inadequate for the study
Outcomes
Primary Outcomes
Not specified
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