UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021790
Receipt number R000025131
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
Date of disclosure of the study information 2016/04/06
Last modified on 2016/04/06 00:50:13

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Basic information

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

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


Objectives

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



Assessment

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


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

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



Eligibility

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


Research contact person

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


Public contact

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


Sponsor or person

Institute

St. Marianna University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


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

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)


Other administrative information

Date of disclosure of the study information

2016 Year 04 Month 06 Day


Related information

URL releasing protocol


Publication of results

Unpublished


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

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

Other related information



Management 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name