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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006758
Receipt No. 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

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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
Email

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
Email

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 Toranomon Hospital
Sapporo Kosei General Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007582

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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