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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000001605 |
Receipt No. | R000001926 |
Scientific Title | peginterferon alfa-2b and ribavirin plus pitavastatin for chronic hepatitis type C : A pilot study |
Date of disclosure of the study information | 2008/12/26 |
Last modified on | 2012/06/27 |
Basic information | ||
Public title | peginterferon alfa-2b and ribavirin plus pitavastatin for chronic hepatitis type C : A pilot study | |
Acronym | peginterferon alfa-2b and ribavirin plus pitavastatin for chronic hepatitis type C | |
Scientific Title | peginterferon alfa-2b and ribavirin plus pitavastatin for chronic hepatitis type C : A pilot study | |
Scientific Title:Acronym | peginterferon alfa-2b and ribavirin plus pitavastatin for chronic hepatitis type C | |
Region |
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Condition | ||
Condition | Chronic hepatitis C | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | efficacy of peginterferon alfa-2b and ribavirin plus pitavastatin |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | |
Developmental phase | Phase I,II |
Assessment | |
Primary outcomes | Sustained virologic response |
Key secondary outcomes | 1) virologic response at
4,8,12,16,20,24weeks and end of therapyt 2) Safety ( moniterd clinical and laboratory evaluation) |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | peginterferon alfa 2b and ribavirin plus pitavastatin | |
Interventions/Control_2 | ||
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | genotype 1 and high virus load | |||
Key exclusion criteria | 1) Patients receiving shosaiko-to
2) Autoimmune hepatitis 3) History of hypersensitivity to PEG-IFN alpha-2b 4) History of hypersensitivity to biological products such as vaccine 5) Decompenstated liver cirrhosis 6) HCC, malignat tumor 7) With or with a history of severe psychosis such as severe depression, suicidal ideation or attempt, etc. 8) Pregnant or lactating women and women who may be pregnant 9) Judged by investigator not to be appropriate for inclusion in this study |
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Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | graduate school of biomedical science, Hiroshima university. | ||||||
Division name | Department and medicine and molecular science | ||||||
Zip code | |||||||
Address | 1-2-3 kasumi, minami-ku, Hiroshima 734-8551 | ||||||
TEL | 082-257-5190 | ||||||
Public contact | |||||||
Name of contact person |
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Organization | graduate school of biomedical science, Hiroshima university | ||||||
Division name | Department and medicine and molecular science | ||||||
Zip code | |||||||
Address | 1-2-3 kasumi, minami-ku, Hiroshima 734-8551 | ||||||
TEL | 082-257-5190 | ||||||
Homepage URL | |||||||
Sponsor | |
Institute | Hiroshima liver study group |
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 | |
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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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001926 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |