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Therapeutic effects of pegylated-interferon (Peg-IFN) therapy combined with ribavirin (RBV) and simeprevir on patients with chronic hepatitis C

Therapeutic effects of pegylated-interferon (Peg-IFN) therapy combined with ribavirin (RBV) and simeprevir on patients with chronic hepatitis C - Investigation of the therapeutic effects regarding a new triple therapy for chronic hepatitis C

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000013715
Enrollment
80
Registered
2014-04-14
Start date
2013-12-16
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-alpha2a/RBV/simeprevir 12weeks plus Peg-IFN-alpha2a/RBV 36weeks: a total of 48 weeks treatment Peg-IFN-alpha2a/RBV/simeprevir 12weeks plus Peg-IFN-alpha2a/RBV 36weeks: a total of 48 weeks tr

Sponsors

Division of Hepatobiliary and Pancreatic Disease, Department of Internal Medicine, Hyogo College of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients having genotype 1b high virus titer chronic hepatitis C (HCV-RNA more than 5 LogIU/mL) who did not achieve early viral response and failed in viral eradication with the previous Peg-IFN plus RBV treatment and who met the following inclusion criteria: laboratory data before study treatment of white blood cell count over 3,000/mm3, neutrophil count over 1,500/mm3,platelet count over 90,000/mm3, and hemoglobin over 12 g/dL

Exclusion criteria

Exclusion criteria: Patients who did not fulfill the criteria to receive the approved Peg-IFN-alpha/RBV/simeprevir treatment

Design outcomes

Primary

MeasureTime frame
The rate of sustained viral response (having undetectable serum HCV-RNA 24 weeks after the end of treatment)

Countries

Japan

Contacts

Public ContactHirayuki Enomoto

Hyogo College of Medicine Division of Hepatobiliary and Pancreatic Disease, Department of Internal Medicine

enomoto@hyo-med.ac.jp0798-45-6472

Outcome results

None listed

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