UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004088 |
|---|---|
| Receipt number | 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 09:45:03 |
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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
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
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004854
