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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003410
Receipt No. R000004086
Scientific Title Peginterferon-alpha plus ribavirin therapy following twice-daily administration of interferon-beta in patients with genotype 1 and high viral load.
Date of disclosure of the study information 2010/04/01
Last modified on 2015/08/30

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Basic information
Public title Peginterferon-alpha plus ribavirin therapy following twice-daily administration of interferon-beta in patients with genotype 1 and high viral load.
Acronym Peginterferon-alpha plus ribavirin therapy following twice-daily administration of interferon-beta in patients with genotype 1 and high viral load.
Scientific Title Peginterferon-alpha plus ribavirin therapy following twice-daily administration of interferon-beta in patients with genotype 1 and high viral load.
Scientific Title:Acronym Peginterferon-alpha plus ribavirin therapy following twice-daily administration of interferon-beta in patients with genotype 1 and high viral load.
Region
Japan

Condition
Condition patients with HCV genotype 1 and high viral load
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of our combined therapy compared to the standard peginterferon-alpha plus ribavirin therapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes The Sustained virological response (SVR) rate
Key secondary outcomes The rate of loss of serum HCV-RNA levels and viral dynamics during therapy

The incidence ratio of adverse effect

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 Treatment
Type of intervention
Medicine
Interventions/Control_1 Interferon-beta
Peginterferon-alpha
Ribavirin
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 HCV-RNA-positive patients.
Patinets with genotype 1b and high viral load (equal to or more than 5.0 LogIU/mL).
Leukocyte count (equal to or more than 1500/mm3).
Neutrophil count (equal to or more than 750/mm3).
Blood platelet count (equal to or more than 50,000/mm3).
Hemoglobin concentration (equal to or more than 10g/dL).
Key exclusion criteria Patients with autoimmune hepatitis.
Pregnant woman, woman of child-bearing potential, or breast-feeding woman.
Patients and thier partners who cannot use birth control durinf therapy and for 6 months after end of administration.
Patients with hypersensitivity to ribavirin, or other nucleoside analogs.
Patients with uncontrollable heart failure.
Patients with hemoglobinopathy.
Patinets with chronic renal failure and compromised renal function (equal to or less than 50mL/min of creatinine clearance.
Patients with severe depression or psychiatric disease including suicide attempt or with history of suicide attempt.
Patients with severe liver dysfunction.
Patients with hypersensitivity to biological drug such as vaccine.
Patients with hypersensitivity to interferon and bovine-derived material.
Patients with interstitial pneumonia.
Patients with a history of drug sensitivity or with allergic tendency.
Patients administrated with Syousaikotou.
Patients with being disqualified by the doctor.
Patients who received peginterferon plus ribavirin therapy.
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken Sato
Organization Gunma University Graduate School of Medicine
Division name Department of Medicine and Molecular Science
Zip code
Address 3-39-15 Showa-machi, Maebashi, Gunma 371-8511
TEL 027-220-8127
Email satoken@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ken Sato
Organization Gunma University Graduate School of Medicine
Division name Department of Medicine and Molecular Science
Zip code
Address 3-39-15 Showa-machi, Maebashi, Gunma 371-8511, Japan
TEL 027-220-8127
Homepage URL
Email satoken@gunma-u.ac.jp

Sponsor
Institute Gunma Liver Study Group
Institute
Department

Funding Source
Organization Gunma Liver Study Group
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 群馬大学医学部附属病院、国立行政法人高崎総合医療センター、前橋赤十字病院、伊勢崎市民病院、桐生厚生総合病院、国立行政法人西群馬病院、くすのき病院、社会保険群馬中央総合病院、群馬県済生会前橋病院、原町赤十字病院、上武呼吸器内科病院、七日市病院、国立行政法人沼田病院、下仁田厚生病院、富岡総合病院、東邦病院、日高病院、平成日高クリニック

Other administrative information
Date of disclosure of the study information
2010 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2010 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 04 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
2010 Year 03 Month 30 Day
Last modified on
2015 Year 08 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004086

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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