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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000007704
Receipt No. 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

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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
Email

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
Email ikedahi@marianna-u.ac.jp

Sponsor
Institute St. Mariaana University School of Medicine
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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008989

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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