Efficacy and safety of ledipasvir/sofosubuvir/ribavirin combination therapy for failures to daculatasvir/asunaprevir combination therapy.

Efficacy and safety of ledipasvir/sofosubuvir/ribavirin combination therapy for failures to daculatasvir/asunaprevir combination therapy. - LDV/SOF/RBV for failures to DCV/ASV.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000022418

Enrollment

Registered

2016-05-23

Start date

2016-08-17

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

Patients infected with HCV genotype 1, who failed to daculatasvir/asunaprevir comnination therapy.

Interventions

Ribavirin add-on ledipasvir/sofosubuvir for 12 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Age of 20 years or more. 2) Patients who have provided written informed consent to participate in this study. 3) HCV genotype 1 4) Chronic hepatitis or compensated cirrhosis. 5) Failures to daculatasvir/asunaprevir combination therapy.

Exclusion criteria

Exclusion criteria: 1) Patients with history of hypersensitivity to HCV NS5A inhibitors/ NS5B inhibitors/ ribavirin. 2) Patients with hepatocellular carcinoma. 3) Females who are pregnant or lactating. 4) Patients with renal dysfunction (eGFR <50 mL/min/1.73m2) and hemodialysis patients. 5) Unsuitable patients for this study who were evaluated by principal investigator.

Design outcomes

Primary

Measure	Time frame
The rates of HCV-RNA negativity at 12 weeks after the completion of therapy (Sustained virological response rates).	—

Countries

Japan

Contacts

Public ContactNorio Akuta

Toranomon Hospital Hepatology

norioakuta@toranomon.gr.jp044-877-5111

Outcome results

None listed

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