UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003410 |
|---|---|
| Receipt number | 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 10:09:50 |
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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
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
satoken@gunma-u.ac.jp
Sponsor or person
Institute
Gunma Liver Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004086
