UMIN-CTR Clinical Trial

Public title

Efficacy and safety on effects of ribavirin with sofosbuir and ledipasvir combination therapy for patients who failed to daclatasvir and asunaprevir combination therapy

Acronym

LDV/SOF+RBV combination therapy for patients with chronic hepatitis C who failed to DAC/ASV therapy

Scientific Title

Efficacy and safety on effects of ribavirin with sofosbuir and ledipasvir combination therapy for patients who failed to daclatasvir and asunaprevir combination therapy

Scientific Title:Acronym

LDV/SOF+RBV combination therapy for patients with chronic hepatitis C who failed to DAC/ASV therapy

Region

Japan

Condition

Patients with chronic hepatitis C, who failed to DCV/ASV therapy

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the efficacy and safety of add-on RBV in sofosbuvir plus ledipasvir therapy for patients with a chronic HCV genotype 1 infection, who failed to DCV/ASV therapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Primary outcomes

To investigate the sustained virologic response (SVR) rate after 12 weeks since administration

Key secondary outcomes

1) SVR 24 rates
2) Virological response rates at 1, 2, 4, 8 week and EOTR
3) Incidence of adverse effects
4) resistance-associated variant

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

LDV/SOF plus RBV 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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who satisfy all the inclusion criteria and meet none of the exclusion criteria are eligible for the study.
(inclusion criteria)
1) Patients with a chronic HCV infection and compensated cirrhosis who failed to DCV/ASV combination therapy
2) HCV-RNA positive
3) Patients who are 20 years of age or older at the time of informed consent
4) ECOG performance status 0 or 1
5) Patients who have been fully informed and have provided written informed consent to participate in this study prior to study initiation

Key exclusion criteria

1) HBV or HIV co-infected patients
2) Patients with a hepatocellular carcinoma, at the start of treatment
3) Patients with pregnancy, or possibility to be pregnant, or on breast feeding
4) Patients with a history of hypersensitivity to other nucleoside-analogue
5) Patients with severe renal dysfunction or need to be treated on hemodialysis
6) Patients with poorly controlled cardiac disease (e.g., myocardial infarction, cardiac failure, arrhythmia)
7) Patients with abnormal hemoglobin disease
8) Patients with severe depression, suicidal ideation, or severe mental illness
9) Patients with severe hepatic impairment
10) Patients with Autoimmune hepatitis
11) Patients taking medicine as below: rifampicin, phenytoin, carbamazepine, seiyouotogisou-including foods
12) Patients who took investigational agents within 3 months prior to this study
13) Patients who are unsuitable for study entry in the opinion of the principal investigator, for this study due to any other reason

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Michihiro Suzuki

Organization

St. Marianna University School of Medicine

Division name

Division of gastroenterology and Hepatology　

Zip code

Address

2-16-1 Sugao, Miyamae-2-16-1 Sugao, Miyamae-ku, Kawasaki City, Kanagawa 216-8511, Japank

TEL

+81449778111

Email

michstmu@marianna-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Hiroki　Ikeda

Organization

St. Marianna University School of Medicine

Division name

Division of gastroenterology and Hepatology　

Zip code

Address

2-16-1 Sugao, Miyamae-2-16-1 Sugao, Miyamae-ku, Kawasaki City, Kanagawa 216-8511, Japan

TEL

+81449778111

Homepage URL

Email

ikedahi@marianna-u.ac.jp

Institute

St. Marianna University School of Medicine

Institute

Department

Personal name

Organization

None

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

聖マリアンナ医科大学病院(神奈川県)、川崎市立多摩病院(神奈川県)、聖マリアンナ医科大学横浜市西部病院(神奈川県)

Date of disclosure of the study information

2016

Year

04

Month

06

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

Date of protocol fixation

2016

Year

01

Month

26

Day

Date of IRB

Anticipated trial start date

2016

Year

04

Month

06

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

04

Month

06

Day

Last modified on

2016

Year

04

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025131