100% VS 80% Of Pegasys In Koreans With Chronic Hepatitis C (CHC)

T

The Catholic University of Korea

Status and phase

Completed
Phase 4

Conditions

Sustained Virologic Response
IL28B Polymorphism

Treatments

Drug: peginterferon alfa 2a (pegasys)
Drug: peginterferon alfa-2a (pegasys)

Study type

Interventional

Funder types

Other

Identifiers

NCT01378104
PEGASYS100:80

Details and patient eligibility

About

Randomized controlled multicenter study The response of reducing dose of peginterferon alfa-2a in Koreans with chronic hepatitis C genotype 1 IL28B polymorphism in Koreans with CHC

Full description

The virologic response of Koreans to combination therapy for chronic hepatitis C is similar to non-Asians; however, dose modification occurs more frequently in Koreans. -When we evaluated the rates of peginterferon α-2a and ribavirin dose modifications and their effect on the virologic response in Koreans, we suggested that using at least 80% of the peginterferon α-2a dose in Koreans not only maintains SVR but also reduces drug side effects during the entire treatment period and a lower dose of ribavirin may be as efficacious as a standard dose(Korean J Intern Med 2009;24:203-211). So we investigate whether the group of 80% use dosage of peginterferon alfa-2a did not show inferior response rather than that of 100 % use dosage group and minimize the adverse events. There are recently reports that Koreans have favorable IL28B SNP for CHC treatment. -We investigate the IL28B polymorphism in Koreans with CHC and this result can effect on the SVR depending on the dosage of peginterferon alfa 2a

Enrollment

178 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • chronic hepatitis C (anti HCV+, HCV RNA +)
  • Genotype 1
  • over 18 year-old
  • Pregnancy test negative if women of childbearing age

Exclusion criteria

  • pregnant women or breast feeding women
  • systemic chemotherapy or steroid therapy before 6 months of trial
  • Coinfection with HAV, HBV, and HIV
  • Other liver disease such as hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxic hepatitis
  • Hepatocellular carcinoma
  • Evidence of decompensation such as variceal bleeding,ascites, encephalopathy
  • ANC less than 1500, platelet less than 90k
  • Cr more than 1.5 of UNL
  • Severe psychiatric problem
  • Poorly controlled thyroid disease
  • Severe retinopathy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

178 participants in 2 patient groups

80% dosage group of peginterferon alfa 2a
Experimental group
Description:
This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment.
Treatment:
Drug: peginterferon alfa 2a (pegasys)
100% dosage group of peginterferon alfa 2a
Active Comparator group
Description:
These group patients would be treated with standard dose 180 ug/week for 48 weeks.
Treatment:
Drug: peginterferon alfa-2a (pegasys)

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems