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Study of new therapy in patients with chronic hepatitis C including liver cirrhosis

Phase 2
Conditions
chronic hepatitis C and liver cirrhosis
Registration Number
JPRN-UMIN000008289
Lead Sponsor
niversity of Tsukuba
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
10
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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
serum albumin concentration
Secondary Outcome Measures
NameTimeMethod
Child-Pugh Score, platelet count, hyarulonic acid, prothrombin time, serum bilirubin, serum cholinesterase
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