Unique ID issued by UMIN | UMIN000007485 |
---|---|
Receipt number | R000007904 |
Scientific Title | Examination of the peginterferon+ribavirin+proteaseinhibitor combined effect for type 1 high viral load chronic hepatitis C |
Date of disclosure of the study information | 2013/01/30 |
Last modified on | 2012/03/11 21:56:07 |
Examination of the peginterferon+ribavirin+proteaseinhibitor combined effect for type 1 high viral load chronic hepatitis C
Examination of the peginterferon+ribavirin+proteaseinhibitor combined effect for type 1 high viral load chronic hepatitis C
Examination of the peginterferon+ribavirin+proteaseinhibitor combined effect for type 1 high viral load chronic hepatitis C
Examination of the peginterferon+ribavirin+proteaseinhibitor combined effect for type 1 high viral load chronic hepatitis C
Japan |
chronic hepatitis C
Hepato-biliary-pancreatic medicine |
Others
YES
We reduce a beginning of dosage dose of RBV by 200 mg (1 capsule) than a prescribed dose and compare the beginning of dosage dose of TVR with the development trial results in 1,500 mg/day (two-thirds of the usual dosage range) and a thing doing more and we have what kind of influence on the expression of effect of treatment and the side effect or examine patients with type 1 high viral load chronic hepatitis C.
Safety,Efficacy
SVRrate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Active
1
Prevention
Medicine |
Peginterferon
Ribavirin
Teraprevir
20 | years-old | < |
Not applicable |
Male and Female
(1)The patients whom it is judged not to be cirrhosis by liver histopathology, an imaging, a blood test.
(2)The patients whom a hepatocellular carcinoma is not found in by imagings.
(3)Age at agreement acquisition; the patients 20 years or older.
(1)
The patients whom it is judged not to be cirrhosis by liver histopathology, an imaging, a blood test.
(2)
The patients whom a hepatocellular carcinoma is not found in by imagings.
(3)
Age at agreement acquisition; the patients 20 years or older.
2)
Exclusion criteria
(1)
It is the patients with a history of hypersensitivity for peginterferon alpha -2 or other interferon preparation.
(2)
It is the patients with a history of hypersensitivity for biological preparation such as the vaccine.
(3)
The patients with a history of ribavirin or other nucleosidic analog (acyclovir, ganciclovir, vidarabine) hypersensitivity.
(4)
A pregnant woman, the woman who may be pregnant or the woman whom we are nursing.
(5)
The patients with heart disorder (myocardial infarction, heart failure, arrhythmia) having difficulty in control.
(6)
The patients with haemoglobinopathies (thalassemia, sickle cell anemia).
(7)
The patients with chronic renal failure or renal dysfunction that is with 50mL/m or less of creatinine clearance.
(8)
The patients in a severe psychotic state or the patients with the medical history with severe depression, suicidal ideation or suicide attempt.
(9)
Patients with serious liver dysfunction.
(10)
Cerebral hemorrhage, the patients with a history of cerebral infarction.
(11)
The patients with autoimmune hepatitis.
(12)
The patients receiving the Sho-saiko-to.
(14)
In addition, the patients who doctor attending intended, and judged that we were inadequate
50
1st name | |
Middle name | |
Last name | Yuichi Hara |
Kawasaki Medical College
Department of Hepatology and Pancreatology
577 Matsushima Kurashiki Okayama
1st name | |
Middle name | |
Last name |
Kawasaki Medical College
Department of Hepatology and Pancreatology
yuich_h777@med.kawasaki-m.ac.jp
Kawasaki Medical College
Kawasaki Medical College
NO
2013 | Year | 01 | Month | 30 | Day |
Unpublished
Open public recruiting
2012 | Year | 01 | Month | 30 | Day |
2012 | Year | 02 | Month | 01 | Day |
2012 | Year | 03 | Month | 11 | Day |
2012 | Year | 03 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007904
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