UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001735
Receipt number R000002088
Scientific Title Effectiveness of PEG-IFN alfa-2b + Ribavirin combination therapy in patients with chronic hepatitis C after partial splenic embolization(PSE) or splenectomy
Date of disclosure of the study information 2009/06/01
Last modified on 2012/02/14 09:40:36

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Basic information

Public title

Effectiveness of PEG-IFN alfa-2b + Ribavirin combination therapy in patients with chronic hepatitis C after partial splenic embolization(PSE) or splenectomy

Acronym

PEG-IFN alfa-2b + Ribavirin combination therapy after PSE or splenectomy

Scientific Title

Effectiveness of PEG-IFN alfa-2b + Ribavirin combination therapy in patients with chronic hepatitis C after partial splenic embolization(PSE) or splenectomy

Scientific Title:Acronym

PEG-IFN alfa-2b + Ribavirin combination therapy after PSE or splenectomy

Region

Japan


Condition

Condition

Chronic Hepatitis C

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the efficacy of PEG-IFN alfa-2b + Ribavirin treatment between patients with chronic hepatitis C after partial splenic embolization(PSE) and splenectomy

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Sustained virological response(SVR)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

All patients are treated with PEG-IFN alfa-2b 1.0-1.5 microgram/kg/week + Ribavirin 400-1000/day. Treatment duration is 48-72 weeks for HCV genotype1 with high viral load and up to 24 weeks for HCV genotype1 with low viral load or genotype2.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Platelet count <80,000/mm3 before PSE or splenectomy
2)Platelet count 80,000/mm3 or more before initiation of PEG-IFN alfa-2b + Ribavirin treatment
3)High serum HCV levels of 5 log IU/ml or more(TaqMan) or previous IFN treatment failure

Key exclusion criteria

1)History of hypersensitivity to PEG-IFN alpha-2b or other interferons
2)History of hypersensitivity to biological products such as vaccine
3)Patients receiving shosaiko-to
4)Autoimmune hepatitis
5)Pregnant or lactating women and women who may be pregnant
6)History of hypersensitivity to ribavirin or other nucleoside analogs
7)Inadequately controlled cardiac disease
8)Hemoglobinopathy
9)Chronic renal failure or renal function disorder with creatinine clearance of 50 ml/min or less
10)With or with a history of severe psychosis such as severe depression, suicidal ideation or attempt, etc.
11)Serious hepatic function disorder
12)Judged by investigator not to be appropriate for inclusion in this study

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akemi Tsutsui

Organization

Tokushima Municipal Hospital

Division name

Department of Internal Medicine

Zip code


Address

2-34, kitajyosanjima-cho, tokushima-shi, tokushima, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Tokushima Municipal Hospital

Division name

Department of Internal Medicine

Zip code


Address

2-34, kitajyosanjima-cho, tokushima-shi, tokushima, Japan

TEL


Homepage URL


Email



Sponsor or person

Institute

Tokushima Municipal Hospital

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

Musashino Red Cross 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



Other administrative information

Date of disclosure of the study information

2009 Year 06 Month 01 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

2009 Year 02 Month 10 Day

Date of IRB


Anticipated trial start date

2009 Year 03 Month 01 Day

Last follow-up date

2015 Year 02 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

2009 Year 02 Month 25 Day

Last modified on

2012 Year 02 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002088


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name