UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001033 |
|---|---|
| Receipt number | R000001204 |
| Scientific Title | An open-label, randomized, controlled trial comparing different dosing regimens with peginterferon alpha-2a plus ribavirin in patients with chronic hepatitis C. |
| Date of disclosure of the study information | 2008/02/29 |
| Last modified on | 2016/02/14 09:07:34 |
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Basic information
Public title
An open-label, randomized, controlled trial comparing different dosing regimens with peginterferon alpha-2a plus ribavirin in patients with chronic hepatitis C.
Acronym
A randomized trial of peginterferon alpha-2a plus ribavirin for chronic hepatitis C.
Scientific Title
An open-label, randomized, controlled trial comparing different dosing regimens with peginterferon alpha-2a plus ribavirin in patients with chronic hepatitis C.
Scientific Title:Acronym
A randomized trial of peginterferon alpha-2a plus ribavirin for chronic hepatitis C.
Region
| Japan |
Condition
Condition
Chronic hepatitis C with serogroup 1 and high 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 different dosing regimens with peginterferon alpha-2a plus ribavirin in patients with chronic hepatitis C.
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 weeks 4, 12, 24, and 48 during treatment and 24 weeks after terminating therapy.
Key secondary outcomes
1. Normalization of alanine aminotransferase levels at weeks 24 and 48 during treatment and 24 weeks after terminating therapy.
2. Adverse event and laboratory abnormality (changes in neutrophil count, platelet count, and hemoglobin concentration).
3. The incidence rates of completion of therapy, dose reduction, and discontinuation of therapy.
4. Assessment of quality of life.
5. HCV Core and NS5A ISDR amino acid replacement and virological response.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Starting with a standard dose of ribavirin in combination with peginterferon alpha-2a, followed by ribavirin reduction by 200 mg/day upon a decline of hemoglobin concentration by 2 g/dL or more from baseline at week 2 of therapy.
Interventions/Control_2
Starting with a ribavirin dose according to the ribavirin apparent clearance in combination with peginterferon alpha-2a, followed by stepwise dose-escalation by 100 mg/day in cases starting with a lower dose of ribavirin and hemoglobin concentration at or above 12 g/dL at week 4 and 8 of therapy.
Interventions/Control_3
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Chronic hepatitis C with HCV serogroup 1 and high viral load (HCV RNA >= 100 KIU/mL).
2. 60 years-old or older.
Key exclusion criteria
1. Pregnant or under breast feeding.
2. Allergic to ribavirin or other nucleoside preparations.
3. Uncontrolled cardiovascular diseases.
4. Abnormal hemoglobinemia.
5. Chronic renal failure or creatinine clearance value less than 50 mL/min.
6. Depression or psychiatric disorders.
7. Sever or decompensated liver disease.
8. Autoimmune liver diseases.
9. White blood cell count <3,000/microL, neutrophil count <1,500/microL, platelet count <90,000/microL, or hemoglobin concentration <12 g/dL.
10. Allergic to pegylated interferon alpha-2a or other interferon preparations.
11. Allergic to vaccine or biological preparations.
12. Concomitant herbal medication such as Sho-saiko-to.
13. Other conditions considered inappropriate by attending physician.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiaki Iwasaki |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
2-5-1, Shikata-cho, Kita-ku, Okayama-city, Okayama, Japan
TEL
086-235-7219
yiwasaki@cc.okayama-u.acjp
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
2-5-1, Shikata-cho, Kita-ku, Okayama-city, Okayama, Japan
TEL
086-235-7219
Homepage URL
yiwasaki@cc.okayama-u.acjp
Sponsor or person
Institute
Okayama University Hospital
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 | 02 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2007 | Year | 09 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2012 | 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 | 02 | Month | 14 | Day |
Last modified on
| 2016 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001204
