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 |
Analysis of iron metabolism during Ledipasvir/Sofosbuvir treatment in patients with genotype 1 hepatitis C virus infection and compensated cirrhosis
Analysis of iron metabolism in chronic hepatitis C and liver cirrhosis treated by Ledipasvir/Sofosbuvir
Analysis of iron metabolism during Ledipasvir/Sofosbuvir treatment in patients with genotype 1 hepatitis C virus infection and compensated cirrhosis
Analysis of iron metabolism in chronic hepatitis C and liver cirrhosis treated by Ledipasvir/Sofosbuvir
Japan |
Chronic hepatitis C, compensated liver cirrhosis
Hepato-biliary-pancreatic medicine |
Others
NO
Evaluation of iron metabolism and improvement of viremia by antiviral therapy in chronic hepatitis C and compensated liver cirrhosis
Safety,Efficacy
Confirmatory
Pragmatic
Phase IV
Variation of iron metabolism at week 24 after antiviral therapy initiation
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Ledipasvir (90 mg) and Sofosbuvir (400 mg) combination tablet, once daily for 12 weeks
20 | years-old | <= |
Not applicable |
Male and Female
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
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
25
1st name | Shotaro |
Middle name | |
Last name | Sakisaka |
Fukuoka University
Gastroenterology and Medicine
814-0180
7-45-1, Nanakuma, Jonan-ku, Fukuoka City, Japan
092-801-1011
syokaki@minf.med.fukuoka-u.ac.jp
1st name | Shinjiro |
Middle name | |
Last name | Inomata |
Fukuoka University
Gastroenterology and Medicine
814-0180
7-45-1, Nanakuma, Jonan-ku, Fukuoka City, Japan
092-801-1011
sinomata@fukuoka-u.ac.jp
Fukuoka University
None
Self funding
Fukuoka University Hospital IRB
Nanakuma, Jonan-ku, Fukuoka City, Japan
092-801-1011
hayakawaka@adm.fukuoka-u.ac.jp
NO
2016 | Year | 02 | Month | 16 | Day |
Unpublished
Completed
2016 | Year | 01 | Month | 26 | Day |
2016 | Year | 02 | Month | 17 | Day |
2018 | Year | 01 | Month | 16 | Day |
2016 | Year | 02 | Month | 14 | Day |
2019 | Year | 04 | Month | 18 | Day |
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 |