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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007485
Receipt No. 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

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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
Institute Kawasaki Medical College
Institute
Department

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
URL(English) https://upload.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


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