UMIN-CTR Clinical Trial

Public title

An explosive study on add-on effects of ribavirin in sofosbuir and ledipasvir combination therapy for patients who failed to daclatasvir and asunaprevir combination therapy.

Acronym

SOF/LDV/RBV combination therapy for patients who failed to DAC/ASV therapy

Scientific Title

An explosive study on add-on effects of ribavirin in sofosbuir and ledipasvir combination therapy for patients who failed to daclatasvir and asunaprevir combination therapy.

Scientific Title:Acronym

SOF/LDV/RBV combination therapy for patients who failed to DAC/ASV therapy

Region

Japan

Condition

Patients with chronic HCV infection, 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 DAC/ASV

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Primary outcomes

To investigate the sustained virologic response (SVR) rate at follow-up Week 12

Key secondary outcomes

Effects of HCV NS5A/B mutations as viral factors on virologic response
2) Rate of emergence of drug-resistant variants
3) Presence or absence of a reversal of liver fibrosis
4) Presence or absence of an improvement in AFP levels
5) Incidence of AEs

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

RBV add-on 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 (1) with the target disease who (2) satisfy all the inclusion criteria and (3) meet none of the exclusion criteria are eligible for the study.
(1) Subjects
Patients with a chronic HCV infection and compensated cirrhosis who failed to DCV/ASV combination therapy
(2) Inclusion criteria
[1] Patients who are 20 years of age or older at the time of informed consent
[2] Patients who have been fully informed and have provided written informed consent to participate in this study prior to study initiation
[3] Patients with a chronic HCV genotype 2 infection and compensated cirrhosis who do not meet any of the following exclusion criteria

Key exclusion criteria

1) Patients with poorly controlled cardiac disease (e.g., myocardial infarction, cardiac failure, arrhythmia)
2) Patients with severe hepatic impairment
3) Patients with a history of hypersensitivity to HCV NS5B inhibitors, Ribavirin and NS5A inhibitors
4) Patients with a concurrent malignancy, including hepatocellular
carcinoma, at the start of treatment
5) Patients deemed unsuitable for
study entry by their treating physician
6) Patients with renal dysfunction
eGFR 50 ml/min
7) Patients who are unsuitable, in the opinion of the principal investigator, for this study due to any other reason

Target sample size

15

Name of lead principal investigator

1st name
Middle name
Last name	Goki Suda

Organization

Hokkaido University

Division name

Department of Gastroenterology and Hepatology, Graduate School of Medicine,

Zip code

Address

Kita 14-jo Nishi 5-jo, Kita-ku, Sapporo city, Hokkaid

TEL

+81117161161

Email

gsudgast@pop.med.hokudai.ac.jp

Name of contact person

1st name
Middle name
Last name	Goki Suda

Organization

Hokkaido University

Division name

Department of Gastroenterology and Hepatology, Graduate School of Medicine,

Zip code

Address

Kita 14-jo Nishi 5-jo, Kita-ku, Sapporo city, Hokkaid

TEL

+81117161161

Homepage URL

Email

gsudgast@pop.med.hokudai.ac.jp

Institute

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

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

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

2015

Year

12

Month

03

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

Completed

Date of protocol fixation

2015

Year

10

Month

22

Day

Date of IRB

2015

Year

10

Month

22

Day

Anticipated trial start date

2015

Year

12

Month

03

Day

Last follow-up date

2020

Year

06

Month

02

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

11

Month

30

Day

Last modified on

2020

Year

06

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023099