UMIN-CTR Clinical Trial

Public title

Efficacy and safety of paritaprevir and ombitasvir in patients with chronic hepatitis C

Acronym

Efficacy and safety of paritaprevir and ombitasvir

Scientific Title

Efficacy and safety of paritaprevir and ombitasvir in patients with chronic hepatitis C

Scientific Title:Acronym

Efficacy and safety of paritaprevir and ombitasvir

Region

Japan

Condition

Patients with chronic hepatitis C virus infection

Classification by specialty

Medicine in general

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To assessment of efficacy and safety of paritaprevir and ombitasvir in patients with chronic hepatits C.
To investigate the relative factor with antiviral effect, emergence of drug-resistant virus and the suppressive effect for incidence of hepatocellular carcinoma.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Primary outcomes

Sustained virologic response rate
Safety
Cumulative incidence of hepatocellular carcinoma

Key secondary outcomes

The factor associated with sustained virologic response
Emergence of drug-resistant virus
The factor associated with incidence of hepatocellular carcinoma

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients with 20 years of age and older
2) Chronic hepatitis or compensated cirrhosis patients with HCV serogroup 1
3) Eligible patients for paritaprevir and ombitasvir

Key exclusion criteria

1)Contraindication to paritaprevir or ombitasvir, ritonavir
2)Contraindication to paritaprevir and ombitasvir

Target sample size

2000

Name of lead principal investigator

1st name	Tetsuo
Middle name
Last name	Takehara

Organization

Osaka University Graduate School of Medicine

Division name

Gastroenterology and Hepatology

Zip code

565-0871

Address

2-2, Yamadaoka, Suita, Osaka, Japan

TEL

81-6-6879-3621

Email

takehara@gh.med.osaka-u.ac.jp

Name of contact person

1st name	Ryotaro
Middle name
Last name	Yamada

Organization

Osaka University Graduate School of Medicine

Division name

Gastroenterology and Hepatology

Zip code

565-0871

Address

2-2, Yamadaoka, Suita, Osaka, Japan

TEL

81-6-6879-3621

Homepage URL

Email

sakamori@gh.med.osaka-u.ac.jp

Institute

Osaka University Graduate School of Medicine, Department of Gastroenterology and Hepatology

Institute

Department

Personal name

Organization

Grant-in-aid from Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Osaka University Clinical Research Review Committee

Address

2-2, Yamadaoka, Suita, Osaka

Tel

06-6210-8289

Email

rinri@hp-crc.med.osaka-u.ac.jp

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

2015

Year

12

Month

10

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

2015

Year

12

Month

10

Day

Date of IRB

Anticipated trial start date

2015

Year

12

Month

10

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Study design
Observational study, Cohort study

Way for subscription of candidate
Patients who fits the inclusion criteria in Osaka University Hospital and other institutions participating in the Osaka Liver Forum between December 2015 and December 2020.

Measurement item
Peripheral blood count (white blood cell, differential leukocyte, red blood cell, hemoglobin, thrombocyte)
Hemostatic test (prothrombin time)
Biochemical test (albumin, total bilirubin, direct bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma-guanosine triphosphate, alpha-fetoprotein, des-gamma-carboxy prothrombin, creatinine, estimated-glomerular filtration rate, c-reactive protein, triglyceride, total cholesterol, LDL-cholesterol, fasting blood sugar, HbA1c, antinuclear antibody, IgG)
Virological test (HCV-RNA, HBs-antigen, HBc-antibody, Mutation of HCV NS5A region (L31/Y93), Mutation of HCV core region (AA70/91), Mutation of ISDR region)
Liver fibrosis test (hyaluronic acid, type 4 collagen 7S, procollagen-III-peptide, Mac2 binding protein Gi)
Single Nucleotide Polymorphism of IL28B
Virological test (HCV-RNA, HBs-antigen, HBc-antibody, Mutation of HCV NS5A region (L31/Y93), Mutation of HCV core region (AA70/91), Mutation of ISDR region)
Liver fibrosis test (hyaluronic acid, type 4 collagen 7S, procollagen-III-peptide, Mac2 binding protein Gi)
Single Nucleotide Polymorphism of IL28B

Registered date

2015

Year

12

Month

01

Day

Last modified on

2019

Year

08

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023114