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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001067
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Japanese Consortium for the Study of Liver Diseases
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001221

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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