UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001067 |
|---|---|
| Receipt number | R000001221 |
| Scientific Title | An open-label, randomized, controlled study of treatment duration of peginterferon alpha-2a monotherapy in patients with chronic hepatitis C |
| Date of disclosure of the study information | 2008/03/31 |
| Last modified on | 2010/01/15 09:48:42 |
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Basic information
Public title
An open-label, randomized, controlled study of treatment duration of peginterferon alpha-2a monotherapy in patients with chronic hepatitis C
Acronym
A randomized trial of peginterferon alpha-2a for chronic hepatitis C
Scientific Title
An open-label, randomized, controlled study of treatment duration of peginterferon alpha-2a monotherapy in patients with chronic hepatitis C
Scientific Title:Acronym
A randomized trial of peginterferon alpha-2a for chronic hepatitis C
Region
| Japan |
Condition
Condition
Chronic hepatitis C with genotype 2a/2b or genotype 1b and low viral load (< 100 KIU/mL)
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy and safety of 24 weeks versus 48 weeks of treatment with peginterferon alpha-2a in chronic hepatitis C patients with genotype 2a/2b or genotype 1b and low viral load (< 100 KIU/mL)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Negative results of qualitative HCV RNA test at 24 weeks after terminating therapy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
PEG-IFN alpha-2a weekly for 24 weeks in patients with negative results of HCV RNA test at week 4 of therapy (Group A)
Interventions/Control_2
PEG-IFN alpha-2a weekly for 48 weeks in patients with negative results of HCV RNA test at week 4 of therapy (Group B)
Interventions/Control_3
PEG-IFN alpha-2a weekly for 48 weeks in patients with positive results of HCV RNA test at week 4 of therapy (Group C)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The following patients with chronic hepatitis C were eligible to enter the trial.
1) 20 years-old or older
2) HCV genotype 2a/2b or genotype 1b and HCV RNA <100 KIU/mL
3) Laboratory test at entry:
1. Neutrophil count >=1,500/mm3
2. Platelet count >=90,000/mm3
3. Hemoglobin concentration >= 10 g/dL
4) Patients who provided written informed consent to participate the study prior to enrollment
Key exclusion criteria
The following patients were excluded.
1. Concomitant herbal medication of Sho-saiko-to
2. Autoimmune hepatitis, alcoholic liver injury, or chronic liver diseases with other underlying causes
3. Allergic to pegylated interferon alpha-2a or other interferon preparations
4. Allergic to vaccine or biological preparations
5. Liver cirrhosis, decompensated liver disease, hepatocellular carcinoma, or other malignant diseases
6. Depression or psychiatric disorders
7. Other conditions considered inappropriate by attending physician
Target sample size
270
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masao Omata |
Organization
University of Tokyo
Division name
Department of Gastroenterology, Faculty of Medicine
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiaki Iwasaki |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
TEL
086-235-7219
Homepage URL
Sponsor or person
Institute
Japanese Consortium for the Study of Liver Diseases
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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.springerlink.com/content/e24m6678xn821177/fulltext.pdf
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
| 2003 | Year | 11 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 03 | Month | 04 | Day |
Last modified on
| 2010 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001221
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
