UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007071 |
|---|---|
| Receipt number | R000008328 |
| Scientific Title | The effect and safety in Telaprevir with combined peginterferon alpha-2b plus ribavirin for chronic hepatitis C patients |
| Date of disclosure of the study information | 2015/12/31 |
| Last modified on | 2016/01/06 11:20:15 |
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Basic information
Public title
The effect and safety in Telaprevir with combined peginterferon alpha-2b plus ribavirin for chronic hepatitis C patients
Acronym
Drug adjustment on adverse effect of telaprevir combined therapy (TPR-dose trial)
Scientific Title
The effect and safety in Telaprevir with combined peginterferon alpha-2b plus ribavirin for chronic hepatitis C patients
Scientific Title:Acronym
Drug adjustment on adverse effect of telaprevir combined therapy (TPR-dose trial)
Region
| Japan |
Condition
Condition
Chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of efficacy and safety of adjustment of drug dose in combination therapy with Telaprevir/ Peginterferon alpha 2a/Ribavirin for chronic hepatitis C patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sustained Virological Response ( SVR ) at week 24
Key secondary outcomes
ALT normalization
Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Telaprevir reduction
Peginterferon alpha 2b
Ribavirin
Interventions/Control_2
Telaprevir
Peginterferon alpha 2b
Ribavirin reduction
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The following chronic hepatitis C patients with Genotype 1 and high viral lord were eligible to enter the trial
HCV-RNA >= 5.0 LogIU/mL
WBC counts>=3,000/microL
Neutrophil counts>=1,500/microL
Hemoglobin concentration>=12g/dL
Platelet counts>=90,000/microL
Presence of liver biopsy is not asked
Presence of the IFN treatment history is not asked
Patients who provided written informed consent to participate the study prior to enrollment
Key exclusion criteria
The following patients were excluded
women of childbearing potential and pregnancy, lactating women
allergic to ribavirin or other nucleoside analogues
an uncontrollable heart trouble( myocardial infarction, heart failure, or arrhythmia)
hemoglobibopathy ( thalassemia, sickle cell disease)
severe renal disease or Ccr<50mL/min
severe depression or psychosomatic disorders
severe liver disease
autoimmune hepatitis or HBV
drug allergy against interferon
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihiro Tamori |
Organization
Osaka City University, Graduate School of Medicine
Division name
Department of Hepatology
Zip code
Address
1-4-3, Asahimachi, Abeno-ku, Osaka
TEL
06-6645-3811
atamori@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Tamori |
Organization
Osaka City University, Graduate School of Medicine
Division name
Department of Hepatology
Zip code
Address
1-4-3, Asahimachi, Abeno-ku, Osaka 545-8585, JAPAN
TEL
06-6645-3435
Homepage URL
webmaster@med.osaka-cu.ac.jp
Sponsor or person
Institute
Department of Hepatology, Osaka City University , Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka City University , Graduate School of Medicine
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
| 2015 | Year | 12 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Telaprevir dose adjustment could prevent anemia progression without weakening the anti-viral effect during triple therapy in patients with HCV.
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
| 2011 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 10 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 20 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 31 | Day |
Other
Other related information
Tamori A, Kioka K, Sakaguchi H, Enomoto M, Hai H, Kawamura E, Hagihara A, Fujii H, Uchida-Kobayashi S, Iwai S, Morikawa H, Murakami Y, Kawasaki Y, Tsuruta D, Kawada N. Effects on anemia of drug adjustment in patients with chronic hepatitis C during telaprevir-combined therapy. Ann Hepatol. 2015 Jan-Feb;14(1):28-35.
Management information
Registered date
| 2012 | Year | 01 | Month | 16 | Day |
Last modified on
| 2016 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008328
| 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 |
