UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015230 |
|---|---|
| Receipt number | R000001203 |
| Scientific Title | Open-label, randomized, controlled study evaluating dose-escalation of peginterferon alpa-2b plus ribavirin in aged patients with chronic hepatitis C |
| Date of disclosure of the study information | 2014/10/01 |
| Last modified on | 2015/06/26 22:29:28 |
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Basic information
Public title
Open-label, randomized, controlled study evaluating dose-escalation of peginterferon alpa-2b plus ribavirin in aged patients with chronic hepatitis C
Acronym
Randomized study evaluating dose-escalation of combination therapy in aged patients with chronic hepatitis C
Scientific Title
Open-label, randomized, controlled study evaluating dose-escalation of peginterferon alpa-2b plus ribavirin in aged patients with chronic hepatitis C
Scientific Title:Acronym
Randomized study evaluating dose-escalation of combination therapy in aged patients with chronic hepatitis C
Region
| Japan |
Condition
Condition
Chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare efficacy and safety of peginterferon alpha-2b plus ribavirin by standard versus reduced dosing of peginterferon administered with ribavirin dose-escalation manner in aged patients with chronic hepatitis C
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of negative results of qualitative HCV RNA test (end-of-treatment and 24 weeks after terminating therapy
Key secondary outcomes
1. Sustained virological response rate according to the time point of viral disappearance
2. Rate of anemia (defined as hemoglobin concentration < 10 g/dL) at every week up to week 8 and every 4 weeks thereafter
3. Incidence of dose modification and discontinuation of therapy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Standard starting dose of peginterferon alpha-2b (pegintron) in combination with lower starting dose of ribavirin (Rebetol) by 200 mg, followed by dose-escalation of ribavirin by 100 mg, when hemoglobin concentration maintained at or above 12 g/dL at week 4 an 8.
Interventions/Control_2
Lower stating dose of peginterferon alpha-2b (pegintron) in combination with lower starting dose of ribavirin (Rebetol) by 200 mg, followed by dose-escalation of ribavirin by 100 mg, when hemoglobin concentration maintained at or above 12 g/dL at week 4 an 8.
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. HCV genotype 1 an HCV RNA level 100,000 IU/mL or more.
2. Cirrhosis has been excluded by histological data, image diagnosis, and laboratory tests.
3. Complication with hepatocellular carcinoma has been ruled out.
Key exclusion criteria
1. Hemoglobin values at entry visit less than 12 g/dL.
2. Allergic to interferon or vaccine preparations.
3. Allergic to ribavirin or other nucleos(t)ide preparations.
4. Pregnant or under breast feeding.
5. Uncontrolled cardiovascular diseases.
6. Abnormal hemoglobinemia.
7. Chronic renal failure or creatinine clearance value less than 50 mL/min.
8. Neurologic or psychiatric disease.
9. Sever or decompensated liver disease.
10. Hypertension or diabetes.
11. History of apoplexy.
12. Autoimmune hepatitis.
13. Chronic hepatitis B or excessive daily intake of alcohol
14. Concomitant immunosuppressive or herbal medication such as Sho-saiko-to.
15. Other conditions considered inappropriate by attending physician.
Target sample size
100
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, Kita-ku, Shikata-cho, Okayama-city, Okayama, Japan
TEL
086-235-7219
yiwasaki@cc.okayama-u.ac.jp
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, Kita-ku, Shikata-cho, Okayama-city, Okayama, Japan
TEL
086-235-7219
Homepage URL
yiwasaki@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
Not applicable
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
| 2014 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://onlinelibrary.wiley.com/doi/10.1002/jmv.24276/abstract
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
| 2005 | Year | 11 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 01 | 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
| 2014 | Year | 09 | Month | 23 | Day |
Last modified on
| 2015 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001203
