UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of response-guided pegylated-interferon alpha-2a mono therapy in hemodialysis patients with chronic hepatitisC
Title of the study (Brief title)	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	Satoshi Mochida
Organization	Saitama Medical University
Division name	Division of Gastroenterology and Hepatology,internal Medicine
Address	38,Morohongou,Moroyama-cho,Iruma-gun,Saitama,Japan
TEL
Email

Public contact
Name of contact person
Organization	Saitama Medical University
Division name	Division of Gastroenterology and Hepatology,internal Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 07 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000004854