Skip to content

The effects of IFN-free 2D regimen (ombitasvir/paritaprevir/ritonavir) on host immune responses against hepatitis C virus

The effects of IFN-free 2D regimen (ombitasvir/paritaprevir/ritonavir) on host immune responses against hepatitis C virus - The effect of HCV elimination on host immune responces against hepatitis C virus

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000020911
Enrollment
200
Registered
2016-02-06
Start date
2016-03-05
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 liver diseases due to infection with genoetype1/serotype 1 hepatitis C virus

Interventions

Viekirax, once per day, 2 tablets per once (Paritaprevir 150mg,Ombitasvir 25mg, ritonavir 100mg), for 12 weeks

Sponsors

Kanazawa University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Patients with chronic hapatitis or compensated liver cirrhosis due to HCV infection, and treated by Viekirax 2) HCV is genotype1 or serotype 1

Exclusion criteria

Exclusion criteria: 1)Patiens who have had allergy to any ingredients of Viekirax 2)Patienes who are taking any medicines which are on the lists of contraindication for coadministration in the pharmaceutical reference of Viekirax 3)Patients who show moderate-severe hepatic dysfunction (Child-Pugh classification B or C) 4)Patients who have been treated for hepatoma within 6 months before taking Viekrax

Design outcomes

Primary

MeasureTime frame
This is an exploratory study to investigate whether 2D therapy with PTV/r/OBV restores host immune response against HCV via comparing changes in gene expression profiles between patients who achieve SVR vs. patients who do not achieve SVR.

Secondary

MeasureTime frame
1)To further explore changes in immune response via analyzing the effect on cytokine changes in peripheral blood and analyzing effect at the molecular level 2)Predicion of hepatoma by using age, sex, fibrotic markers (APRI, FIB-4, and Fibro test etc.), fibrotic scoring, and cellular immunity 3)To explore host or viral factors contributing to SVR

Countries

Japan

Contacts

Public ContactTetsuro Shimakami

Kanazawa University Hospital Department of Gastroenterology

shimakami@m-kanazawa.jp076-265-2235

Outcome results

None listed

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