UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007704 |
|---|---|
| Receipt number | R000008989 |
| Scientific Title | Efficacy and Safety of Extended Triple Therapy, Peginterferon, Ribavirin and Telaprevir (Telavic) for Genotype1 and High Viral Load Chronic Hepatitis C Patients with IL28B Minor Allele |
| Date of disclosure of the study information | 2012/04/09 |
| Last modified on | 2012/04/09 17:04:43 |
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Basic information
Public title
Efficacy and Safety of Extended Triple Therapy, Peginterferon, Ribavirin and Telaprevir (Telavic) for Genotype1 and High Viral Load Chronic Hepatitis C Patients with IL28B Minor Allele
Acronym
ESPRiT study
Scientific Title
Efficacy and Safety of Extended Triple Therapy, Peginterferon, Ribavirin and Telaprevir (Telavic) for Genotype1 and High Viral Load Chronic Hepatitis C Patients with IL28B Minor Allele
Scientific Title:Acronym
ESPRiT study
Region
| Japan |
Condition
Condition
Chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate the efficacy and safety of extended triple therapy, peg-interferon, ribavirin and telaprevir fo genotype1 and high viral load chronic hepatitis C with IL28B minor allele
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Sustend virologic response (SVR)
Key secondary outcomes
(1)End of treatment response (ETR)
(2)Virologic response at 12 week after the end of therapy
(3)Changes in HCV RNA level
(4)Dose of telaprevir
(5)Adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
(IL28B Major Allele)
Telaprevir plus peginterferon alfa-2b/ribavirin for 12 weeks, followed by 12 additional weeks of peginterferon alfa 2b and ribavirin
Interventions/Control_2
(IL28B Minor Allele)
Telaprevir plus peginterferon alfa-2b/ribavirin for 12 weeks, followed by 12 additional weeks of peginterferon alfa 2b and ribavirin
Interventions/Control_3
(IL28B Minor Allele)
Telaprevir plus peginterferon alfa-2b/ribavirin for 12 weeks, followed by 36 additional weeks of peginterferon alfa 2b and ribavirin
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Serogroup 1 and high virus load(>=5 logIU/mL)(regardless of previous IFN treatment)
2) neutorphil : >=1,000/uL
Platelet : >=70,000/uL
Hemoglobin : >=10g/dL
(less than three months before treatment start)
3) Patients with ECOG Performance Status (PS) of 0 or 1
4) IL28B SNP(rs8099917)is known.
Key exclusion criteria
1) Patients with HBs antigen positive
2) Pregnant or lactating women, or women who may become pregnant
3) Patients with allergy to telaprevir
4) Patients with severe skin reactions when telaprevir administered
5) Patients with allergy to ribavirin and/or other nucleoside analogs
6) Patients with allergy to IFN
7) Patients with severe heart disease
8) Patients with hemoglobinopathy
9) Patients with contraindicated drugs as below
(a)Antiarrhythmics
Quinidine Sulfate
Bepridil Hydrochloride Hydrate
Flecainide Acetate
Propafenone Hydrochloride
Amiodarone Hydrochloride
(b)Ergot derivatives
Ergotamine tartrate
Dihydroergotamine mesilate
Ergometrine maleate
Methylergometrine maleate
(c)HMG-CoA reductase inhibitors
Lovastatin
Simbastatin
Atorvastatin calcium hydrate
(d)PDE5 inhibitors
Vardenafil Hydrochloride Hydrate
Sildenafil Citrate (for treatment of pulmonary arterial hypertension)
Tadalafil (for treatment of pulmonary arterial hypertension)
(e)Others
Pimozide
Triazolam
Alfuzosin
Blonanserin
Colchicine (to patients with liver disorder and/or renal disorder)
Rifampicin
10) Patients with renal failure and/or renal dysfunction (=>50mL/min.)
11) Patients with severe psychosis such as severe depression, suicidal ideation or attempt or with history of severe psychosis
12) Patients with autoimmune hepatitis
13) Patients receiving shosaiko-to
14) Patients with history of hypersensitivity to biological products
15) Patients taking other test drugs less than three months before treatment start
16) Patients who were not suitable for this trial judged by the attending doctor
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michihiro Suzuki |
Organization
Kawasaki Municipal Tama Hospital
Division name
Gastroenterology and Hepatology
Zip code
Address
1-30-37 Shukugawara Tama-ku Kawasaki 214-8525
TEL
044-933-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Ikeda |
Organization
St. Mariaana University School of Medicine
Division name
Gastroenterology and Hepatology
Zip code
Address
2-16-1 Sugao Miyamae-ku Kawasaki 216-8511
TEL
044-977-8111
Homepage URL
ikedahi@marianna-u.ac.jp
Sponsor or person
Institute
St. Mariaana University School of Medicine
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
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
聖マリアンナ医科大学病院（神奈川県）、川崎市立多摩病院（神奈川県）、聖マリアンナ医科大学横浜市西部病院（神奈川県）、清川病院（東京都）、横浜市立大学附属市民総合医療センター（神奈川県）、神奈川県立がんセンター（神奈川県）、北里大学東病院（神奈川県）、北里大学病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 09 | Day |
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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 02 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 09 | Day |
Last modified on
| 2012 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008989
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
