UMIN-CTR Clinical Trial

Public title

Response-Guided Interferon Therapy for patients with chronic hepatitis C of the Genotype 1 high viral load: Japanese multi-center, randomized controlled study: (ReGIT-J study)

Acronym

Response-Guided Interferon Therapy for patients with chronic hepatitis C : Japanese multi-center, randomized controlled study: (ReGIT-J study)

Scientific Title

Response-Guided Interferon Therapy for patients with chronic hepatitis C of the Genotype 1 high viral load: Japanese multi-center, randomized controlled study: (ReGIT-J study)

Scientific Title:Acronym

Response-Guided Interferon Therapy for patients with chronic hepatitis C : Japanese multi-center, randomized controlled study: (ReGIT-J study)

Region

Japan

Condition

Chronic hepatitis C

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

We examined treatment method and duration from the HCV-RNA negativity time in an PEG-IFN alfa-2 a/RBV combination therapy or a PEG-IFNalfa-2a/RBV combination therapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV

Primary outcomes

Virological response:SVR
HCVRNA negativity of 24 weeks of end of treatment

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

8

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

PEG-IFN alfa-2a monotherapy in the patients who undetectable HCV-RNA at week 4

Interventions/Control_2

PEG-IFNalfa-2a/Ribavirin combination therapy in the patients who undetectable HCV-RNA at week 4

Interventions/Control_3

PEG-IFN alfa-2a once a week/ Ribavirin combination therapy in the patients who detectable HCV-RNA at week 4 but undetectable HCV-RNA at week 12

Interventions/Control_4

PEG-IFN alfa-2a biweekly/Ribavirin combination therapy in the patients who detectable HCV-RNA at week 4 but undetectable HCV-RNA at week 12

Interventions/Control_5

PEG-IFNalfa-2a/Ribavirin combination therapy in the patients who detectable HCV-RNA at week 12 but undetectable HCV-RNA at week 24

Interventions/Control_6

PEG-IFNalfa-2a/Ribavirin/Fluvastatin combination therapy in the patients who detectable HCV-RNA at week 12 but undetectable HCV-RNA at week 24

Interventions/Control_7

PEG-IFN alfa-2a half dose long term maintenance therapy in the patients who detectable HCV-RNA at week 24

Interventions/Control_8

A treatment cancellation follow-up in the patients who detectable HCV-RNA at week 24

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1.Existence of previous treatment (interferon therapy including a Ribavirin combined therapy) is not asked.
2.Genotype1,more than HCV-RNA 100KIU/ml
3.Baseline of the following clinical laboratory test result / before a medication start -- the patient who filled all
WBC count : more than3,000/mm3
neutrophil count: more than 1,500/mm3
PLT count:more than 90,000/mm3
Hemoglobin content :more than12g/dl
4.The patient by sufficient understanding top after being given ( sufficient ) in participation of an exam, and a document -- the patient by whom the consent by the free intention of the person himself/herself was got

Key exclusion criteria

1.A pregnant woman, the woman who may have become pregnant, or the woman under breastfeeding
2.The patient who has an anamnesis of hypersensitivity to the ingredient or other nucleoside analogs of this agent (acyclovir, ganciclovir, Bidarabin, etc.)
3.A patient with cardiac disease (myocardial infarction, heart failure, abnormal heart rhythm etc.) with difficult control
4.The patient of abnormal hemoglobin diseases (sarasemia, drepanocytic anemia, etc.)
5.The patient to whom the following renal dysfunction has chronic renal failure or a creatinine clearance by 50mL/min
6.A patient with the patient in serious mental disease states, such as serious depression, suicide ideation, or a suicide attempt, or its anamnesis
7.A critical impaired liver function patient
8.The patient of autoimmune hepatitis
9.The patient who is prescribing Syousaikotou
10.The chronic liver disease patient of others, such as autoimmune hepatitis and alcoholic hepatitis
11.The patient who has an anamnesis of hypersensitivity to the ingredient or other interferon tablets of this agent
12.The patient who has an anamnesis of hypersensitivity to biological preparation, such as a vaccine
13.The patient of liver cirrhosis, hepatic insufficiency, and cancer of liver
14.The patient who meets at least one standard of the following clinical laboratory test result / before a medication start
before treatment
WBC count Less than 3,000/mm3
neutrophil count Less than 1,500/mm3
PLT count Less than 90,000/mm3
Hemoglobin content Less than 12g/dl
15.In addition, the patient whom the examination doctor in attendance judged that the participation to an exam is unsuitable

Target sample size

300

Name of lead principal investigator

1st name
Middle name
Last name	Shuhei Nishiguchi

Organization

Hyogo College Of Medicine

Division name

Division of Hepatobiliary and Pancreatic Diseases Department of Internal Medicine

Zip code

Address

1-1 Mukogawa, Nishinomiya, Hyogo, Japan

TEL

0798-45-6472

Email

Name of contact person

1st name
Middle name
Last name	Teruhisa Yamamoto

Organization

Hyogo College Of Medicine

Division name

Division of Hepatobiliary and Pancreatic Diseases Department of Internal Medicine

Zip code

Address

1-1 Mukogawa, Nishinomiya, Hyogo, Japan

TEL

0798-45-6472

Homepage URL

Email

Institute

Hyogo College Of Medicine

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

None

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

石切生喜病院（大阪府）、大阪医科大学（大阪府）、大阪赤十字病院（大阪府）、
関西医科大学附属枚方病院（大阪府）、関西医科大学附属滝井病院（大阪府）、
近畿大学（大阪府）、神戸朝日病院（兵庫県）、新生病院（大阪府）、摂津ひかり病院（大阪府）、
大正病院（大阪府）、田辺中央病院（大阪府）、兵庫医科大学（兵庫県）、枚方市民病院（大阪府）、
北摂総合病院（大阪府）、牧病院（大阪府）、守口敬仁会病院（大阪府）、
わかこうかい病院（大阪府）

Date of disclosure of the study information

2009

Year

11

Month

11

Day

URL releasing protocol

Publication of results

Published

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

Recruitment status

Completed

Date of protocol fixation

2007

Year

05

Month

01

Day

Date of IRB

Anticipated trial start date

2007

Year

05

Month

01

Day

Last follow-up date

2010

Year

12

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2009

Year

11

Month

11

Day

Last modified on

2016

Year

11

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003242