UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006758 |
|---|---|
| Receipt number | R000007582 |
| Scientific Title | Randomised study assessing efficacy and safety of telaprevir evey 8 or 12 hours with peginterferon alfa 2b and ribavirin in HCV patients |
| Date of disclosure of the study information | 2011/12/01 |
| Last modified on | 2013/11/22 19:18:56 |
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Basic information
Public title
Randomised study assessing efficacy and safety of telaprevir evey 8 or 12 hours with peginterferon alfa 2b and ribavirin in HCV patients
Acronym
Study of telaprevir evey 8 or 12 hours
Scientific Title
Randomised study assessing efficacy and safety of telaprevir evey 8 or 12 hours with peginterferon alfa 2b and ribavirin in HCV patients
Scientific Title:Acronym
Study of telaprevir evey 8 or 12 hours
Region
| Japan |
Condition
Condition
Chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Investigate the efficacy, safety, tolerability, and pharmacokinetics of telaprevir administered q8h or q12h in combination with peginterferon alfa 2b.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
sustend virologic response
Key secondary outcomes
virologic response at4,8,12,24 weeks
Safety ( moniterd clinical and laboratory evaluation)
pharmacokinetics
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
YES
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
telaprevir 750 mg q8h plus peginterferon alfa-2b/ribavirin
Interventions/Control_2
telaprevir 750 mg q12h plus peginterferon alfa-2b/ribavirin
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
Genotype 1 and high virus load
IL28BSNP (rs8099917) TT or
IL28BSNP (rs8099917) nonTT with transient response to prior treatment
Key exclusion criteria
1) Patients receiving shosaiko-to
2) Autoimmune hepatitis
3) History of hypersensitivity to PEG-IFN alpha-2b and telaprevir
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
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuaki Chayama |
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
| 1st name | |
| Middle name | |
| Last name | Yoshiiku Kawakami |
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 or person
Institute
Hiroshima liver study group
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
Toranomon Hospital
Sapporo Kosei General Hospital
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
広島大学病院（広島県）、虎の門病院（東京都）、札幌厚生病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 01 | 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
SVR12 rates were 92.3% (24/26) for both q8h and q12h. The changes in mean log10 HCV RNA levels and viral response were also similar in q8h compared to q12h, whereas pharmacokinetic properties such as Cmax, AUC0-24h and Ctrough of TVR were slightly higher in q8h than in q12h (P>0.2). The frequency of TVR discontinuation due to anemia or renal damage was significantly higher in q12h than in q8h (6/26(23%) vs. 0/20, respectively; P=0.02). Antivir Ther. 2013 Nov 5. doi: 10.3851
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 | 09 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | 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
| 2011 | Year | 11 | Month | 22 | Day |
Last modified on
| 2013 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007582
