Efficacy and safe of Ledipasvir/Sofosbuvir with Ribavirin in Patients who failed Daclatasvir/Asunaprevir with chronic hepatitis C-multicenter,pilot study-

Efficacy and safe of Ledipasvir/Sofosbuvir with Ribavirin in Patients who failed Daclatasvir/Asunaprevir with chronic hepatitis C-multicenter,pilot study- - Retreatment of Patients who failed DCV/ASV with LDV/SOF+RBV

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000021969

Enrollment

Registered

2016-04-19

Start date

2016-04-25

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

Ledipasvir/Sofosbuvir with Ribavirin Ledipasvir/Sofosbuvir with Ribavirin (Precedence)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who failed Daclatasvir/Asunaprevir with chronic hepatitis C

Exclusion criteria

Exclusion criteria: 1) Patients with serious renal disease(eGFR<30mL/min/1.73m2) or dialysis 2) Patients with haemoglobinopathies (thalassemia, sickle cell anemia) 3) Decompenstated liver cirrhosis 4) HCC, malignat tumor 5) Patients with Hb less than 10 g/dl. 6) Pregnant or lactating women and women who may be pregnant 7) Judged by investigator not to be appropriate for inclusion in this study

Design outcomes

Primary

Measure	Time frame
sustained virologic response 12 weeks after treatment	—

Secondary

Measure	Time frame
virologic response at 1,2,3,4,8,12weeks and sustend virologic response Safety ( moniterd clinical and laboratory evaluation)	—

Countries

Japan

Contacts

Public ContactYoshiiku Kawakami

graduate school of biomedical science, Hiroshima university Department and medicine and molecular science

kamy4419@hiroshima-u.ac.jp082-257-5190

Outcome results

None listed

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