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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004088
Receipt No. R000004854
Scientific Title Efficacy and safety of response-guided pegylated-interferon alpha-2a mono therapy in hemodialysis patients with chronic hepatitisC
Date of disclosure of the study information 2010/08/27
Last modified on 2018/09/21

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Basic information
Public title Efficacy and safety of response-guided pegylated-interferon alpha-2a mono therapy in hemodialysis patients with chronic hepatitisC
Acronym Efficacy and safety of response-guided pegylated-interferon alpha-2a mono therapy in hemodialysis patients with chronic hepatitisC
Scientific Title Efficacy and safety of response-guided pegylated-interferon alpha-2a mono therapy in hemodialysis patients with chronic hepatitisC
Scientific Title:Acronym Efficacy and safety of response-guided pegylated-interferon alpha-2a mono therapy in hemodialysis patients with chronic hepatitisC
Region
Japan

Condition
Condition Chronic hepatitis C
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Efficacy and safety of response-guided pegylated-interferon alpha-2a mono therapy in hemodialysis patients with chronic hepatitisC
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Negative result of HCV RNA test at 24 weeks after terminating therapy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 PEG-IFN alfa2a weekly for 24weeks in patients with negative results of HCV RNA test at week4 of therapy (GroupA)
Interventions/Control_2 PEG-IFN alfa2a weekly for 48weeks in patients with negative results of HCV RNA test at week12 of therapy (GroupB)
Interventions/Control_3 PEG-IFN alfa2a weekly for 72weeks in patients with negative results of HCV RNA test at week36 of therapy (GroupC)
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
18 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria The following patients with chronic hepatitis C were eligible to enter the trial
1) The patients were hemodialysis at least 3months and had detectable HCV RNA
2)Serogroup doesn't ask it
3)Neutrophil count >=1,500/mm3.Hemoglobin concentration >10g/dL.Platelet count >=90,000/mm3
4) The presence of the liver biopsy is not asked
5) From 18 years old or over to 70years old or less
6)Patients who provided written informed consents to participate the study prior to enrollment
Key exclusion criteria The following patients were excluded
1)Allegic history to interferon preparations
2)Autoimmune hepatitis,alcoholic liver injury,or chronic liver diseases with other underlying causes
3)Liver cirrhosis,decompensated liver diseases
4) Abnormal thyroid function
5)Concomitant herbal medication of Sho-saikoto
6) history of interstitial pneumonia
7) Women of childbearing potential and pregnancy, lactating woman
8)severe depression
9)Allergic to vaccine or biological preparations
10)Other conditions considered inappropriate by attending physician
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Mochida
Organization Saitama Medical University
Division name Division of Gastroenterology and Hepatology,internal Medicine
Zip code
Address 38,Morohongou,Moroyama-cho,Iruma-gun,Saitama,Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Saitama Medical University
Division name Division of Gastroenterology and Hepatology,internal Medicine
Zip code
Address 38,Morohongou,Moroyama-cho,Iruma-gun,Saitama,Japan
TEL
Homepage URL
Email

Sponsor
Institute Saitama Medical University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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 埼玉医科大学病院(埼玉県)、おおしまクリニック(埼玉県)、かみのクリニック(埼玉県)、クボジマクリニック(埼玉県)、くまがやクリニック(埼玉県)、こいづかクリニック(埼玉県)、さやま腎クリニック(埼玉県)、シャローム鋤柄医院(埼玉県)、越生メディカルクリニック(埼玉県)、岡村記念クリニック(埼玉県)、岡病院(埼玉県)、寄居本町クリニック(埼玉県)、高坂医院(埼玉県)、小川病院(埼玉県)、松本クリニック(埼玉県)、池袋病院(埼玉県)、東松山メディカルクリニック(埼玉県)、東松山宏仁クリニック(埼玉県)、東飯能駅前クリニック(埼玉県)、関越病院(埼玉県)、南町クリニック(埼玉県)、入間駅前クリニック(埼玉県)、入間台クリニック(埼玉県)、武蔵嵐山病院(埼玉県)、若葉内科クリニック(埼玉県)

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 27 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 Completed
Date of protocol fixation
2010 Year 07 Month 12 Day
Date of IRB
Anticipated trial start date
2010 Year 08 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 08 Month 24 Day
Last modified on
2018 Year 09 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004854

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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