UMIN ID: UMIN000002177
Registered date:10/07/2009
Prospective randomized controlled trial Comparing Peg-IFN alpha-2a monotherapy versus Peg-IFN alpha-2a +ribavirin combination therapy after curative ablation for HCV-positive Hepatocellular Carcinoma
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Chronic hepatitis C Hepatocellular carcinoma |
| Date of first enrollment | 2008/06/01 |
| Target sample size | 95 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | peginterferon alfa-2a monotherapy peginterferon alfa-2a 180microgram(12W) +90microgram(84W):HCV-RNA>=2log drop peginterferon alfa-2a in combination with ribavirin:peginterferon alfa-2a 180microgram(12W) +90microgram(84W)+Ribavirin5.5mg/kg 48w(13-60w):HCV-RNA>=2log drop peginterferon alfa-2a monotherapy peginterferon alfa-2a 180microgram(12W) +90microgram(84W):HCV-RNA<=2log drop |
Outcome(s)
| Primary Outcome | Disease-free survival rates 2.5-year survival rates 3.Safety |
|---|---|
| Secondary Outcome | 1. Disease-free survival rates (each groups) 2. Changes in the serum HCV RNA level 3. Changes in the serum alanine aminotransferase level |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Patient with 1.pregnant or lactating women and women who may be pregnant 2. a man who can not avoid conception during administration of ribavirin and until 6 month after the end ribavirin treatment 3. allergic to ribavirin or nucleoside analogues 4.hemoglobinopathy(thalassemia, sickle cell disease) 5.an uncontrollable heart trouble (myocardial infarction, heart failure, or arrhythmia) 6.an poorly controlled diabetes mellitus and hypertension 7. severe renal disease, Ccr <50ml/min 8. severe depression or psychosomatic disorders 9 .liver disease such as autoimmune hepatitis 10.clinical laboratory date does not meet selection criterion 11. drug allergy against interferon |
Related Information
| Primary Sponsor | Yokohama City University Medical Center Gastroenterological Center |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Akito Nozaki |
| Address | 4-57,Urafune,Minami-ku,Yokohama City 232-0024, Japan Japan |
| Telephone | 045-261-5656 |
| akino@yokohama-cu.ac.jp | |
| Affiliation | Yokohama City University Medical Center Gastroenterological Center |
| scientific contact | |
| Name | Kazushi Numata |
| Address | 4-57,Urafune,Minami-ku,Yokohama City 232-0024, Japan Japan |
| Telephone | 045-261-5656 |
| kz-numa@urahp.yokohama-cu.ac.jp | |
| Affiliation | Yokohama City University Medical Center Gastroenterological Center |