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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000021011

Enrollment

Registered

2016-02-16

Start date

2016-02-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic hepatitis C, compensated liver cirrhosis

Interventions

Ledipasvir (90 mg) and Sofosbuvir (400 mg) combination tablet, once daily for 12 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Variation of iron metabolism at week 24 after antiviral therapy initiation	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactShinjiro Inomata

Fukuoka University Gastroenterology and Medicine

sinomata@fukuoka-u.ac.jp092-801-1011

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026