UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010587
Receipt number R000012365
Scientific Title Comprehensive and individualized trial of teraprevir/peginterferon alpha-2b/ribavirin for chronic hepatitis C patients with genotype 1 and high viral loads
Date of disclosure of the study information 2013/05/01
Last modified on 2015/08/30 10:53:18

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Basic information

Public title

Comprehensive and individualized trial of teraprevir/peginterferon alpha-2b/ribavirin for chronic hepatitis C patients with genotype 1 and high viral loads

Acronym

CITATION

Scientific Title

Comprehensive and individualized trial of teraprevir/peginterferon alpha-2b/ribavirin for chronic hepatitis C patients with genotype 1 and high viral loads

Scientific Title:Acronym

CITATION

Region

Japan


Condition

Condition

chronic hepatitis C patients with genotype 1 and high viral loads

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To increase SVR ratio

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

virological response

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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


Not applicable

Gender

Male and Female

Key inclusion criteria

1. patients with a positive HCV-RNA in the serum (more than or equal to 5.0 log IU/mL)
2. patients with genotype 1a or 1b
3. patients who gave consent in writing

Key exclusion criteria

1. chronic hepatitis such as autoimmune hepatitis and alcoholic hepatitis
2. pregnant women, women who may be expecting a child or lactating woman
3. women of child-bearing potential and their partner who cannot use birth control during administration and for 6 months after completion of administration
4. male partner for a pregnant woman, who cannot use birth control during administration and for 6 months after completion of administration
5. patients with past history of hypersensitivity to IFN or bovine-derived material
6. patients with past history of hypersensitivity to ribavirin and other nucleoside analog
7. patients with past history of hypersensitivity to biological products
such as vaccine
8. patients with uncontrolled diabetes mellitus
9. patients with uncontrolled heart disease
10. patients with hemoglobinopathy
11. chronic renal failure or severe renal dysfunction with less than 50 mL/min Ccr
12. patients with severe depression, suicidal thinking or suicide attempt or past history of any of these diseases
13. patients with severe liver dysfunction
14. patients with interstitial pneumonitis
15. patients with past history of drug hypersensitivity or tendency to develop allergy
16. patients receiving Shosaikoto
17. patients judged as inappropriate by the doctor

Target sample size

73


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ken Sato

Organization

Gunma University Graduate School of Medicine

Division name

Department of Medicine and Molecular Science

Zip code


Address

3-39-22

TEL

027-220-8127

Email

satoken@gunma-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ken Sato

Organization

Gunma University Graduate School of Medicine

Division name

Department of Medicine and Molecular Science

Zip code


Address

Department of Medicine and Molecular Science

TEL

027-220-8127

Homepage URL


Email

satoken@gunma-u.ac.jp


Sponsor or person

Institute

Gunma University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Gunma 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


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



Other administrative information

Date of disclosure of the study information

2013 Year 05 Month 01 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Completed

Date of protocol fixation

2011 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 01 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

prospective cohort


Management information

Registered date

2013 Year 04 Month 24 Day

Last modified on

2015 Year 08 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012365


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name