UMIN-CTR Clinical Trial

Public title

Promoting hospital-hospital referral system for hepatitis C virus carriers to hepatologist: multi-center study

Acronym

Promoting hospital-hospital referral system for hepatitis C virus carriers to hepatologist: multi-center study

Scientific Title

Promoting hospital-hospital referral system for hepatitis C virus carriers to hepatologist: multi-center study

Scientific Title:Acronym

Promoting hospital-hospital referral system for hepatitis C virus carriers to hepatologist: multi-center study

Region

Japan

Condition

Hepatitis C virus carriers

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Our object is developing an effective regional network for hepatitis treatment, where a core center, specialized hospitals and primary physicians cooperate with each other in accordance to eradicate hepatitis C virus (HCV) in patients with HCV-related liver disease. In the present situations, only a few patients who are required HCV treatment after HCV screening test, visited hepatologists. Moreover, HCV-positive patients do not always receive appropriate hepatitis treatment at medical institutions when they visit non-specialized hospitals for liver disease. In order to address these issues, we propose a new hospital-hospital/ clinics referral system. Many HCV carriers are detected by screening tests in non-specialized hospital. However, since non-specialists aren't very familiar with liver disease, they can't necessarily provide information to their patients regarding how to be treated with viral infection or whom to consult with. Because intra-hospital referral system has been introduced in several facilities, showing effectiveness in some extent, we can apply a hospital-hospital or clinic referral system to enlarge treatment subjects and take a step forward. To establish the effective hospital network, we need the convenient referral system to disseminate the importance of hepatitis treatment for the purpose of preventing the disease progression to liver cirrhosis or hepatocellular carcinoma (HCC).

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

We evaluate the effectiveness of hospital-hospital referral system for hepatitis C virus carriers to hepatologist.
Our primary endpoint of this study is to increase follow-up rate and treatment rate of HCV-positive patients who are proved positive by screening test.

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. At least 18 years old
2. With chronic genotype 1 and/or genotype 2 HCV infection
3. Patients providing written informed consent

Key exclusion criteria

1. Any organ failure not due to aging
2.Decompensated cirrhotic patients
3. HCC patients
4.. Under treatment of hepatitis virus eradication
5. Severe bacterial infection
6. Severe mental illness
7. Severe cardiac disease
8. Severe endocrine metabolic disease
9. Patients with malignant tumors
10. Determined who is inappropriate by doctor

Target sample size

2000

Name of lead principal investigator

1st name
Middle name
Last name	Yuataka Sasaki

Organization

Kumamoto University

Division name

Department of Gastroenterology and Hepatology Graduate School of Medical Sciences

Zip code

Address

1-1-1 Honjo, Chuou-ku, Kumamoto City, Kumamoto 860-8556, JAPAN.

TEL

096-373-5150

Email

sasakiy@kumamoto-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Hiroko Setoyama

Organization

Kumamoto University

Division name

Department of Gastroenterology and Hepatology Graduate School of Medical Sciences

Zip code

Address

1-1-1 Honjo, Chuou-ku, Kumamoto City, Kumamoto 860-8556, JAPAN.

TEL

096-373-5150

Homepage URL

Email

setoyamahiroko@kuh.kumamoto-u.ac.jp

Institute

Kumamoto University

Institute

Department

Personal name

Organization

Kumamoto University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

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

Date of disclosure of the study information

2017

Year

11

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Preinitiation

Date of protocol fixation

2017

Year

04

Month

26

Day

Date of IRB

Anticipated trial start date

2017

Year

11

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

We totalize the data every 3 months for the following items.
(a) Total number of patients who visit our department
(b) Total number of referrals from partner hospitals
(c) Total number of HCV-Ab positive patients in partner hospitals
(d) The number of HCV-Ab positive patients who are already under the medical treatment. (Out of (c))
(e) The number of HCV-Ab positive patients who led to treatment. (Out of (a), (c))
We also calculate follow-up rate, treatment rate, referral rate based on these data.
(f) Follow-up rate = (b)/(c)-(d)
(g) Treatment rate = (e)/(c)-(d)
(h) Referral rate = (b)/(a)

Registered date

2017

Year

10

Month

30

Day

Last modified on

2017

Year

10

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033993