Efficacy and safety of Simeprevir/PEG alpha-IFN-2a/RBV therapy for patients with chronic hepatitis C after resection of hepatocellular carcinoma

Efficacy and safety of Simeprevir/PEG alpha-IFN-2a/RBV therapy for patients with chronic hepatitis C after resection of hepatocellular carcinoma - Simeprevir/PEG alpha-IFN-2a/RBV therapy for patients with chronic hepatitisC after resection of HCC

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012937

Enrollment

100

Registered

2014-03-01

Start date

2014-03-10

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

PEG IFN alpha-2a 180microgram/w+Ribavirin+Simeprevir 100mg/day Daclatasvir 60mg/day + Asunaprevir 200mg/day Observation Group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with chronic hepatitis C after resection of hepatocellular carcinoma, are fit with all criteria. 1.Ages >=20,80<= 2.3 month after complete response to resection confirmed by imaging 3.Platelet counts >=90000/mm3(interferon group only) 4.Neutrophil counts >=1500/mm3(interferon group only) 5.Hemoglobin concentration >= 12g/dL(interferon group only) 6.Having received adequate explanation of the contents of the trial and given their written consent.

Exclusion criteria

Exclusion criteria: 1.Concomitant herbal medication of Sho-saiko-to. 2.History of interstitial pneumonia 3.Autoimmune hepatitis 4.Allegic to vaccine or biological preperations. 5.Uncontrolled cardiopathy. 6.Hemoglobinopathy. 7.Chronic renal failure or renal dysfunction with creatinine clearance <=50mL/min. 8.Severe depression or psychosomatic disorders. 9.Patients with moderate liver diseases.(Child-Pugh grade BorC) 10.Patient with a history of photosensitivity 11.Women of childbearing potential and pregnancy, lactating women. 12.Drug allegy against interferon or nucleoside analog. 13.Patients receiving rifampicin, rifabutin, phenytoin, carbamazepine, phenobarbital, systemic administration of dexamethasone, azole antifungal drug, clarithromycin, erythromycin, diltiazem, verapamil hydrochloride, cobicistat included drugs,HIV Protease inhibitor, modafinil, nonnucleoside reverse transcriptase inhibitor(except for rilpivirine hydrochloride), bosentan hydrate, St John's Wort included foods, cyclosporine, flecainide, propafenone. 14.Other conditions considered inappropriate by attending physician

Design outcomes

Primary

Measure	Time frame
Sustained virological response rate	—

Secondary

Measure	Time frame
Intrahepatic recurrence rate	—

Countries

Japan

Contacts

Public ContactMasaki Kaibori

Kansai Medical University Department of Surgery

kaibori@hirakata.kmu.ac.jp072-804-0101

Outcome results

None listed

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