UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027851
Receipt number R000031904
Scientific Title Efficacy and safety of Ledipasvir/Sofosbuvir in chronic hepatitis C of Genotype1b with chronic kidney disease(eGFR30-60ml/min/1.73m2)
Date of disclosure of the study information 2017/06/21
Last modified on 2020/04/29 07:32:01

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Basic information

Public title

Efficacy and safety of Ledipasvir/Sofosbuvir in chronic hepatitis C of Genotype1b with chronic kidney disease(eGFR30-60ml/min/1.73m2)

Acronym

Efficacy and safety of Ledipasvir/Sofosbuvir in patient with chronic kidney disease

Scientific Title

Efficacy and safety of Ledipasvir/Sofosbuvir in chronic hepatitis C of Genotype1b with chronic kidney disease(eGFR30-60ml/min/1.73m2)

Scientific Title:Acronym

Efficacy and safety of Ledipasvir/Sofosbuvir in patient with chronic kidney disease

Region

Japan


Condition

Condition

Chronic hepatitis C

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To confirm the efficacy and safety of Ledipasvir and Sofosbuvir combination therapy for genotype1b-infected chronic hepatitis C patients with chronic kidney disease

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Sustained virological response rate

Key secondary outcomes

1. Change in serum HCV RNA during treatment and follow-up duration
2. Change in hematological and biochemical test during treatment and follow-up duration
3.Change of renal function during a treatment period
4. Frequency of a side effect during a treatment period
5. Change in Mac-2 Binding Protein,hyaluronic acid, type IV collagen,gamma globulin during treatment and follow-up duration.


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

Patients were treated with Ledipasvir and Sofosbuvir combination therapy

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

18 years-old <=

Age-upper limit

85 years-old >

Gender

Male and Female

Key inclusion criteria

Patients with chronic hepatitis C who treat with Ledipasvir/Sofosbuvir combination therapy.

Key exclusion criteria

1.History of allergy to Ledipasvir and Sofosbuvir.
2.Decompensated liver cirrhosis
3.pregnant woman or lactating mother
4.Hepatocellular carcinoma, or other malignant tumor.
5.severe depression
6.Judged by investigator not to be appropriate for inclusion in this study
7.Patient with dialysis or patients with severe renal function disorder (eGFR<30ml/min/1.73m2)
8.Receiving contraindicated drugs for
Ledipasvir and Sofosbuvir combined therapy

Target sample size

700


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masanori Atsukawa

Organization

Nippon Medical School Chiba Hokusoh Hospital

Division name

Division of Gastroenterology

Zip code


Address

1715,Kamakari,Inzai,Chiba, 270-1694, Japan

TEL

0476-99-1111

Email

atsukawa-nms@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masanori Atsukawwa

Organization

Nippon Medical School Chiba Hokusoh Hospital

Division name

Division of Gastroenterology

Zip code


Address

1715,Kamakari,Inzai,Chiba, 270-1694, Japan

TEL

0476-99-1111

Homepage URL


Email

atsukawa-nms@umin.ac.jp


Sponsor or person

Institute

Nippon Medical School Chiba Hokusoh Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Nippon Medical School Hospital
Nippon Medical School Musashi Kosugi Hospital
The Jikei University Hospital
Otakanomori Hospital
Hakujikai Healthcare foundation
Tokyo Metropolitan Bokutoh Hospital
Tokyo Medical University Ibaraki Medical Center
Shinmatsudo Central General Hospital
Japanese Red Cross Narita Hospital

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



Other administrative information

Date of disclosure of the study information

2017 Year 06 Month 21 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

Completed

Date of protocol fixation

2015 Year 09 Month 01 Day

Date of IRB

2015 Year 09 Month 15 Day

Anticipated trial start date

2015 Year 09 Month 01 Day

Last follow-up date

2020 Year 03 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 06 Month 21 Day

Last modified on

2020 Year 04 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031904


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name