UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018453
Receipt number R000021372
Scientific Title Relationship between viral clearance and prevention of carcinogenesis in patients with chronic hepatitis genotype2 treated with sofosuvubir plus ribavirin combination therapy
Date of disclosure of the study information 2015/07/29
Last modified on 2017/07/29 21:16:36

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Basic information

Public title

Relationship between viral clearance and prevention of carcinogenesis in patients with chronic hepatitis genotype2 treated with sofosuvubir plus ribavirin combination therapy

Acronym

Efficacy of sofosuvubir plus ribavirin combination therapy for patients with chronic hepatitis genotype 2

Scientific Title

Relationship between viral clearance and prevention of carcinogenesis in patients with chronic hepatitis genotype2 treated with sofosuvubir plus ribavirin combination therapy

Scientific Title:Acronym

Efficacy of sofosuvubir plus ribavirin combination therapy for patients with chronic hepatitis genotype 2

Region

Japan


Condition

Condition

Chronic hepatitis C

Classification by specialty

Hepato-biliary-pancreatic medicine Adult

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To analyze the predictive factors associated with virologic response in sofosuvubir and ribavirin combination therapy for genotype 2 infected chronic hepatitis C patients.
To analyze the incidence of hepatocellular carcinoma after sofosuvubir and ribavirin combination therapy prospectively.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Sustained virologic response rate at 12 weeks after the completion of treatment

Key secondary outcomes

1. Changes in serum HCV RNA during treatment and follow-up duration
2. Changes in hematological and biochemical test during treatment and follow-up duration
3. Changes in Mac-2 Binding Protein,hyaluronic acid, type IV collagen,gamma globulin during treatment and follow-up duration
4. Changes in fibrosis during treatment and follow-up duration by fibroscan
5. Analysis of the relationship between ITPA(Inosine triphosphate pyrophosphatase)gene polymorphism and the treatment response
6. The resistance profile of sofosubuvir and the concentration of ribavirin before the treatment, during the treatment, and after the treatment.
7. The carciogenic rate of hepatocellular carcinoma after the treatment


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

The patients were treated with sofosubuvir plus ribavirin combination therapy for 12 weeks.

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

18 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

Patients with chronic hepatitis C who were treated with sofosubuvir plus ribavirin combination therapy or other new agents.

Key exclusion criteria

1. History of allergy to sofosubuvir, Ribavirin, and other nucleotide analog.
2. severe renal disorder or chronic renal failure on hemodialysis
3. medication with carbamazepine, phenytoin, rifampicin, St. John's wort
4. pregnant woman or lactating mother
5. poorly controlled heart disease
6. hemoglobinopathy
7. severe depression
8. autoimmune hepatitis
9. Hepatocellular carcinoma, or other malignant tumor
10. severe liver disorder (T-Bil>3.0mg/dL, and/or PT%<70%, and/or Alb<3.4g/dL)
11. Judged by investigator not to be appropriate for inclusion in this study

Target sample size

300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masanori Atsukawa

Organization

Nippon Medical School Chiba Hokusoh Hospital

Division name

Division of Gastroenterology

Zip code


Address

1715,Kamakari,Inzai,Chiba, 270-1694, Japan

TEL

0476-99-1111

Email

atsukawa-nms@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masanori Atsukawa

Organization

Nippon Medical School Chiba Hokusoh Hospital

Division name

Division of Gastroenterology

Zip code


Address

1715,Kamakari,Inzai,Chiba, 270-1694, Japan

TEL

0476-99-1111

Homepage URL


Email

atsukawa-nms@umin.ac.jp


Sponsor or person

Institute

Nippon Medical School Chiba Hokusoh Hospital

Institute

Department

Personal name



Funding Source

Organization

Nippon Medical School Chiba Hokusoh Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

None


Other related organizations

Co-sponsor

Nippon Medical School
Nippon Medical School Musashikosugi Hospital
Shinmatsudo Central General Hospital
Ootakanomori Hospital
Jikei University Kashiwa Hospital
Hakujikai Memorial 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

日本医科大学千葉北総病院(千葉県)Nippon Medical School Chiba Hokusoh Hospital
日本医科大学付属病院(東京都)Nippon Medical School (Tokyo)
日本医科大学武蔵小杉病院(神奈川県)Nippon Medical School Musashikosugi Hospital (Kanagawa)         
新松戸中央総合病院(千葉県)Shinmatsudo Central General Hospital (Chiba)
おおたかの森病院(千葉県)Ootakanomori Hospital (Chiba)          
東京慈恵会医科大学付属柏病院(千葉県)Jikei University Kashiwa Hospital (Chiba) 東京慈恵会医科大学葛飾医療センター(東京都)Jikei University Katsushika Medical center(Tokyo )
博慈会記念総合病院(東京都)Hakujikai Memorial Hospital (Tokyo)


Other administrative information

Date of disclosure of the study information

2015 Year 07 Month 29 Day


Related information

URL releasing protocol


Publication of results

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

2015 Year 07 Month 22 Day

Date of IRB


Anticipated trial start date

2015 Year 07 Month 29 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

2015 Year 07 Month 28 Day

Last modified on

2017 Year 07 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021372


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name