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Efficacy and safety of Ledipasvir Plus Sofosbuvir in Patients With Hepatitis C Virus Genotype 2 Infection

Efficacy and safety of Ledipasvir Plus Sofosbuvir in Patients With Hepatitis C Virus Genotype 2 Infection - Harvoni in Genotype 2 HCV patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000038604
Enrollment
80
Registered
2019-12-01
Start date
2020-03-31
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 With Hepatitis C Virus Genotype 2 Infection

Interventions

None listed

Sponsors

Ogaki Municipal Hospital
Lead Sponsor
Internal Medicine, Japanese Red Cross Society Himeji Hospital Department of Hepatology, Kagawa Prefectural Central Hospital Center for Gastroenterology, Teine Keijinkai Hospital Gastroenterology Center, Ehime Prefectural Central Hospital Division of Gastroenterology and Hepatology, Department of Internal Medicine, Otakanomori Hospital Department of Gastroenterology, Asahi General Hospital Department of Hepatology, Saiseikai Niigata Daini Hospital Department of Gastroenterology, Okayama Ci
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: More than 20 years old and had chronic infection with HCV genotype 2. With or without Child-Pugh A compensated cirrhosis. Body weight more than 40 kg. Written informed consent

Exclusion criteria

Exclusion criteria: Prior exposure to a direct-acting antiviral agent targeting HCV NS5A or NS5B Decompensated cirrhosis Creatinine clearance (Cockcroft-Gault) less than 30 mL/min

Design outcomes

Primary

MeasureTime frame
Safety and efficacy of ledipasvir-sofosbuvir for 12 weeks treatment with Japanese GT2 patients

Secondary

MeasureTime frame
Completion rate for treatment completion (without discontinuation of safety reason).

Countries

Japan

Contacts

Public ContactTakashi Kumada

Gifu Kyoritsu University Department of Nursing, Faculty of Nursing

takashi.kumada@gmail.com+81-584-77-3512

Outcome results

None listed

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