Skip to content

A Study on Predictors of Treatment Response to Sofosbuvir and Ledipasvir Therapy in Patients with genotype 1 Chronic Hepatitis C Virus Infection

A Study on Predictors of Treatment Response to Sofosbuvir and Ledipasvir Therapy in Patients with genotype 1 Chronic Hepatitis C Virus Infection - Predictor of treatment response to SOF LDV therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000019011
Enrollment
260
Registered
2015-10-01
Start date
2015-10-09
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 genotype 1 HCV infection

Interventions

None listed

Sponsors

Department of Gastroenterology and Hepatology, Graduate School of Medicine, Hokkaido University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients (1) with the target disease who (2) satisfy all the inclusion criteria and (3) meet none of the exclusion criteria are eligible for the study. (1) Subjects Patients with a chronic HCV infection and compensated cirrhosis who are being treated as outpatients or inpatients at institutions participating in this study (2) Inclusion criteria [1] Patients who are 20 years of age or older at the time of informed consent [2] Patients who have been fully informed and have provided written informed consent to participate in this study prior to study initiation [3] Patients with a chronic HCV genotype 2 infection and compensated cirrhosis who do not meet any of the following exclusion criteria

Exclusion criteria

Exclusion criteria: 1 Patients with poorly controlled cardiac disease (myocardial infarction, cardiac failure, arrhythmia) 2 Patients with severe hepatic impairment 3 Patients with a history of hypersensitivity to HCV NS5B inhibitors or Ribavirin 4 Patients with a concurrent malignancy, including hepatocellular carcinoma, at the start of treatment 5 Patients deemed unsuitable for study entry by their treating physician 6 Patients with renal dysfunction 7 Patients who are unsuitable, in the opinion of the principal investigator, for this study due to any other reason

Design outcomes

Primary

MeasureTime frame
To investigate the predictors obtained at baseline and affecting the sustained virologic response (SVR) rate/occurrence of adverse drug reactions at follow-up Week 12

Countries

Japan

Contacts

Public ContactGoki Suda

Hokkaido University Department of Gastroenterology and Hepatology, Graduate School of Medicine,

gsudgast@pop.med.hokudai.ac.jp+81-11-716-1161

Outcome results

None listed

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