UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009711
Receipt number R000011386
Scientific Title The efficacy and safety of telaprevir-based triple therapy in elderly patients with HCV genotype 1 chronic hepatitis C, in comparison with the younger patients
Date of disclosure of the study information 2013/01/07
Last modified on 2013/07/07 14:04:52

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Basic information

Public title

The efficacy and safety of telaprevir-based triple therapy in elderly patients with HCV genotype 1 chronic hepatitis C, in comparison with the younger patients

Acronym

The efficacy and safety of telaprevir-based triple therapy in elderly patients with HCV genotype 1 chronic hepatitis C, in comparison with the younger patients

Scientific Title

The efficacy and safety of telaprevir-based triple therapy in elderly patients with HCV genotype 1 chronic hepatitis C, in comparison with the younger patients

Scientific Title:Acronym

The efficacy and safety of telaprevir-based triple therapy in elderly patients with HCV genotype 1 chronic hepatitis C, in comparison with the younger patients

Region

Japan


Condition

Condition

Chronic hepatitis C

Classification by specialty

Medicine in general Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study is done to evaluate the efficacy and tolerability of a triple therapy with telaprevir (TVR) added to pegylated interferon-alpha 2b and ribavirin in elderly patients.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

TVR-based triple therapy can be used successfully and safely to treat elderly patients with genotype 1 chronic hepatitis C.

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

Adult patients with HCV genotype 1 chronic hepatitis C

Key exclusion criteria

Exclusion criteria were: (1) positivity for antibody to human immunodeficiency virus or positivity for hepatitis B surface antigen; (2) clinical or biochemical evidence of hepatic decompensation (ascites, bleeding varices, or encephalopathy); (3) other causes of liver disease (autoimmune hepatitis, primary biliary cirrhosis, or steatohepatitis); (4) excessive active alcohol consumption (a daily intake of more than 40 g of ethanol) or drug abuse; (5) suspected HCC at entry; or (6) treatment with antiviral or immunosuppressive agents prior to enrollment.

Target sample size

400


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Jun Hayashi

Organization

Kyushu University Hospital

Division name

Department of General Internal Medicine

Zip code


Address

3-1-1, Maidashi, Higashi-Ku, Fukuoka, 812-8582, Japan

TEL

092-642-5908

Email



Public contact

Name of contact person

1st name
Middle name
Last name Norihiro Furusyo

Organization

Kyushu University Hospital

Division name

Department of General Internal Medicine

Zip code


Address

3-1-1, Maidashi, Higashi-Ku, Fukuoka, 812-8582, Japan

TEL

092-642-5909

Homepage URL


Email



Sponsor or person

Institute

Kyushu University Hospital

Institute

Department

Personal name



Funding Source

Organization

Kyushu University Hospital

Organization

Division

Category of Funding Organization

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 01 Month 07 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

2011 Year 12 Month 01 Day

Last follow-up date

2013 Year 07 Month 01 Day

Date of closure to data entry

2013 Year 07 Month 01 Day

Date trial data considered complete

2013 Year 07 Month 01 Day

Date analysis concluded

2013 Year 07 Month 08 Day


Other

Other related information

TVR-based triple therapy can be used successfully and safely to treat elderly patients with genotype 1 chronic hepatitis C.


Management information

Registered date

2013 Year 01 Month 07 Day

Last modified on

2013 Year 07 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011386


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name