Analysis of iron metabolism during Ledipasvir/Sofosbuvir treatment in patients with genotype 1 hepatitis C virus infection and compensated cirrhosis
Phase 4
- Conditions
- Chronic hepatitis C, compensated liver cirrhosis
- Registration Number
- JPRN-UMIN000021011
- Lead Sponsor
- Fukuoka University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Variation of iron metabolism at week 24 after antiviral therapy initiation
- Secondary Outcome Measures
Name Time Method 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