UMIN-CTR Clinical Trial

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

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Basic information

Public title

Examination of the peginterferon+ribavirin+proteaseinhibitor combined effect for type 1 high viral load chronic hepatitis C

Acronym

Examination of the peginterferon+ribavirin+proteaseinhibitor combined effect for type 1 high viral load chronic hepatitis C

Scientific Title

Examination of the peginterferon+ribavirin+proteaseinhibitor combined effect for type 1 high viral load chronic hepatitis C

Scientific Title:Acronym

Examination of the peginterferon+ribavirin+proteaseinhibitor combined effect for type 1 high viral load chronic hepatitis C

Region

Japan


Condition

Condition

chronic hepatitis C

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

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.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

SVRrate

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

Peginterferon
Ribavirin
Teraprevir

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

(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.

Key exclusion criteria

(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

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuichi Hara

Organization

Kawasaki Medical College

Division name

Department of Hepatology and Pancreatology

Zip code


Address

577 Matsushima Kurashiki Okayama

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Kawasaki Medical College

Division name

Department of Hepatology and Pancreatology

Zip code


Address


TEL


Homepage URL


Email

yuich_h777@med.kawasaki-m.ac.jp


Sponsor or person

Institute

Kawasaki Medical College

Institute

Department

Personal name



Funding Source

Organization

Kawasaki Medical College

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2013 Year 01 Month 30 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2012 Year 01 Month 30 Day

Date of IRB


Anticipated trial start date

2012 Year 02 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 03 Month 11 Day

Last modified on

2012 Year 03 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007904


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name