Efficacy and Safety of Ombitasvir plus Paritaprevir/r combination regimen for Hepatitis C infected patients with immune disorders

Efficacy and Safety of Ombitasvir plus Paritaprevir/r combination regimen for Hepatitis C infected patients with immune disorders - Ombitasvir /Paritaprevir/r therapy for patients with immune disorders

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000020302

Enrollment

Registered

2015-12-24

Start date

2016-01-04

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 who have immune disorder

Interventions

None listed

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 immune disorder, who have a chronic HCV infection and compensated cirrhosis (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 1 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 (e.g., myocardial infarction, cardiac failure, arrhythmia) 2) Patients with severe hepatic impairment 3) Patients with a history of hypersensitivity to HCV protease inhibitors or NS5A inhibitor 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 who are unsuitable, in the opinion of the principal investigator, for this study due to any other reason

Design outcomes

Primary

Measure	Time frame
To evaluate efficacy (SVR12 rate) and safety of Ombitasvir / Paritaprevir/r therapy in CHC patients with immune disorders (cryoglobulinemia or Sjogrens syndrome)	—

Secondary

Measure	Time frame
To assess the effect of HCV treatment on the status of immune disorders (cryoglobulinemia or Sjogrens syndrome). 2)mutations as viral factors on virologic response 3) Rate of emergence of drug-resistant variants 4) Presence or absence of a reversal of liver fibrosis 5) Presence or absence of an improvement in AFP levels 6) Effects of glucose/lipid-related factors on treatment response	—

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