UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021011
Receipt number R000024249
Scientific Title Analysis of iron metabolism during Ledipasvir/Sofosbuvir treatment in patients with genotype 1 hepatitis C virus infection and compensated cirrhosis
Date of disclosure of the study information 2016/02/16
Last modified on 2019/04/18 17:06:46

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Basic information

Public title

Analysis of iron metabolism during Ledipasvir/Sofosbuvir treatment in patients with genotype 1 hepatitis C virus infection and compensated cirrhosis

Acronym

Analysis of iron metabolism in chronic hepatitis C and liver cirrhosis treated by Ledipasvir/Sofosbuvir

Scientific Title

Analysis of iron metabolism during Ledipasvir/Sofosbuvir treatment in patients with genotype 1 hepatitis C virus infection and compensated cirrhosis

Scientific Title:Acronym

Analysis of iron metabolism in chronic hepatitis C and liver cirrhosis treated by Ledipasvir/Sofosbuvir

Region

Japan


Condition

Condition

Chronic hepatitis C, compensated liver cirrhosis

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of iron metabolism and improvement of viremia by antiviral therapy in chronic hepatitis C and compensated liver cirrhosis

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

Variation of iron metabolism at week 24 after antiviral therapy initiation

Key secondary outcomes

1. Variation of liver inflammation, fibrosis and carcinogenesis
2. Variation of glycolipid metabolism
3. Variation of reactive oxygen species
4. Sustained viral response rate and its predictors


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

Ledipasvir (90 mg) and Sofosbuvir (400 mg) combination tablet, once daily 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

1. Chronic hepatitis and compensated liver cirrhosis with HCV genotype 1 infection
2. Hb more than 12 g/dL
3. Patients who provided written informed consent to participate in this study
4. Patients who meet none of the bellow exclusion criteria

Key exclusion criteria

1. Pregnant or lactating
2. History of hypersensitivity to HCV protease inhibitors
3. Positive for Daclatasvir or Asunaprevir-resistant HCV
4. Viable HCC
5. Poorly controlled cardiac disease (e.g., myocardial infarction, cardiac failure, arrhythmia)
6. Hemoglobinopathy
7. Severe renal dysfunction (eGFR less than 30 mL/min/1.73 m2)
8. Decompensated liver cirrhosis
9. Autoimmune hepatitis
10. Patients who have administered prohibited substances
11. Poorly controlled diabetes
12. Any other patients who are regarded as unsuitable for this study by the investigator

Target sample size

25


Research contact person

Name of lead principal investigator

1st name Shotaro
Middle name
Last name Sakisaka

Organization

Fukuoka University

Division name

Gastroenterology and Medicine

Zip code

814-0180

Address

7-45-1, Nanakuma, Jonan-ku, Fukuoka City, Japan

TEL

092-801-1011

Email

syokaki@minf.med.fukuoka-u.ac.jp


Public contact

Name of contact person

1st name Shinjiro
Middle name
Last name Inomata

Organization

Fukuoka University

Division name

Gastroenterology and Medicine

Zip code

814-0180

Address

7-45-1, Nanakuma, Jonan-ku, Fukuoka City, Japan

TEL

092-801-1011

Homepage URL


Email

sinomata@fukuoka-u.ac.jp


Sponsor or person

Institute

Fukuoka University

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


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Fukuoka University Hospital IRB

Address

Nanakuma, Jonan-ku, Fukuoka City, Japan

Tel

092-801-1011

Email

hayakawaka@adm.fukuoka-u.ac.jp


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

2016 Year 02 Month 16 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

2016 Year 01 Month 26 Day

Date of IRB


Anticipated trial start date

2016 Year 02 Month 17 Day

Last follow-up date

2018 Year 01 Month 16 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 02 Month 14 Day

Last modified on

2019 Year 04 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024249


Research Plan
Registered date File name
2019/07/02 研究計画書.doc

Research case data specifications
Registered date File name
2019/07/02 症例data.xlsx

Research case data
Registered date File name
2019/07/02 症例data.xlsx