|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
JPRN |
|
Last refreshed on:
|
17 October 2023 |
|
Main ID: |
JPRN-UMIN000002177 |
|
Date of registration:
|
10/07/2009 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
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
|
|
Scientific title:
|
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 - Comparing Peg-IFN alpha-2a(+RBV) for HCV-positive hepatocellular carcinoma patients after curative ablation. |
|
Date of first enrolment:
|
2008/06/01 |
|
Target sample size:
|
95 |
|
Recruitment status: |
Complete: follow-up complete |
|
URL:
|
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002671 |
|
Study type:
|
Interventional |
|
Study design:
|
Parallel Randomized
|
|
Phase:
|
Phase IV
|
|
|
Countries of recruitment
|
|
Japan
| | | | | | | |
|
Contacts
|
|
Name:
|
Kazushi Numata |
|
Address:
|
4-57,Urafune,Minami-ku,Yokohama City 232-0024, Japan
Japan |
|
Telephone:
|
045-261-5656 |
|
Email:
|
kz-numa@urahp.yokohama-cu.ac.jp |
|
Affiliation:
|
Yokohama City University Medical Center Gastroenterological Center |
|
|
Name:
|
Akito Nozaki |
|
Address:
|
4-57,Urafune,Minami-ku,Yokohama City 232-0024, Japan
Japan |
|
Telephone:
|
045-261-5656 |
|
Email:
|
akino@yokohama-cu.ac.jp |
|
Affiliation:
|
Yokohama City University Medical Center Gastroenterological Center |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
Exclusion 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
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Chronic hepatitis C Hepatocellular carcinoma
|
|
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
|
|
Primary Outcome(s)
|
|
Disease-free survival rates 2.5-year survival rates 3.Safety
|
|
Secondary Outcome(s)
|
|
1. Disease-free survival rates (each groups) 2. Changes in the serum HCV RNA level 3. Changes in the serum alanine aminotransferase level
|
|
Source(s) of Monetary Support
|
|
None
|
|
Ethics review
|
Status: YES
Approval date:
Contact:
|
|
Results
|
|
Results available:
|
Yes |
|
Date Posted:
|
|
|
Date Completed:
|
31/05/2016 |
|
URL:
|
|
|
|