Relationship between viral clearance and prevention of carcinogenesis in patients with chronic hepatitis genotype2 treated with sofosuvubir plus ribavirin combination therapy

Relationship between viral clearance and prevention of carcinogenesis in patients with chronic hepatitis genotype2 treated with sofosuvubir plus ribavirin combination therapy - Efficacy of sofosuvubir plus ribavirin combination therapy for patients with chronic hepatitis genotype 2

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000018453

Enrollment

300

Registered

2015-07-29

Start date

2015-07-29

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

Interventions

The patients were treated with sofosubuvir plus ribavirin combination therapy for 12 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with chronic hepatitis C who were treated with sofosubuvir plus ribavirin combination therapy or other new agents.

Exclusion criteria

Exclusion criteria: 1. History of allergy to sofosubuvir, Ribavirin, and other nucleotide analog. 2. severe renal disorder or chronic renal failure on hemodialysis 3. medication with carbamazepine, phenytoin, rifampicin, St. John's wort 4. pregnant woman or lactating mother 5. poorly controlled heart disease 6. hemoglobinopathy 7. severe depression 8. autoimmune hepatitis 9. Hepatocellular carcinoma, or other malignant tumor 10. severe liver disorder (T-Bil>3.0mg/dL, and/or PT%<70%, and/or Alb<3.4g/dL) 11. Judged by investigator not to be appropriate for inclusion in this study

Design outcomes

Primary

Measure	Time frame
Sustained virologic response rate at 12 weeks after the completion of treatment	—

Secondary

Measure	Time frame
1. Changes in serum HCV RNA during treatment and follow-up duration 2. Changes in hematological and biochemical test during treatment and follow-up duration 3. Changes in Mac-2 Binding Protein,hyaluronic acid, type IV collagen,gamma globulin during treatment and follow-up duration 4. Changes in fibrosis during treatment and follow-up duration by fibroscan 5. Analysis of the relationship between ITPA(Inosine triphosphate pyrophosphatase)gene polymorphism and the treatment response 6. The resistance profile of sofosubuvir and the concentration of ribavirin before the treatment, during the treatment, and after the treatment. 7. The carciogenic rate of hepatocellular carcinoma after the treatment	—

Measure

Time frame

1. Changes in serum HCV RNA during treatment and follow-up duration 2. Changes in hematological and biochemical test during treatment and follow-up duration 3. Changes in Mac-2 Binding Protein,hyaluronic acid, type IV collagen,gamma globulin during treatment and follow-up duration 4. Changes in fibrosis during treatment and follow-up duration by fibroscan 5. Analysis of the relationship between ITPA(Inosine triphosphate pyrophosphatase)gene polymorphism and the treatment response 6. The resistance profile of sofosubuvir and the concentration of ribavirin before the treatment, during the treatment, and after the treatment. 7. The carciogenic rate of hepatocellular carcinoma after the treatment

—

Countries

Japan

Contacts

Public ContactMasanori Atsukawa

Nippon Medical School Chiba Hokusoh Hospital Division of Gastroenterology

atsukawa-nms@umin.ac.jp0476-99-1111

Outcome results

None listed

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