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

Sustained Virologic Response Clinical Trial

Official title:

The Response of Reducing Dose of Peginterferon Alfa-2a in Koreans With Chronic Hepatitis C Genotype 1; Randomized Controlled Multicenter Study 100% Versus 80%

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01378104
• Other study ID #: PEGASYS100:80
• Status: Completed
• Phase: Phase 4
• First received: June 16, 2011
• Last updated: February 3, 2013
• Start date: October 2008
• Est. completion date: September 2012

Study information

• Verified date: February 2013
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

1. Randomized controlled multicenter study

2. The response of reducing dose of peginterferon alfa-2a in Koreans with chronic hepatitis C genotype 1

3. IL28B polymorphism in Koreans with CHC

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: September 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• IL28B Polymorphism
• Sustained Virologic Response

Intervention

Drug:
• peginterferon alfa 2a (pegasys)
dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable
• peginterferon alfa-2a (pegasys)
These patients would be treated with standard dose 180ug /week for 48 weeks. In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose.

Locations

Country	Name	City	State
Korea, Republic of	Soonchunghyang University Hospital	Bucheon
Korea, Republic of	Hallym University Chunchun Medical center	Chunchun
Korea, Republic of	Keimyung University hospital	Daegu
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Ghungnam National University hospital	Daejun
Korea, Republic of	Konyang University hospital	Daejun
Korea, Republic of	Incheon St. Mary's Hospital	Incheon
Korea, Republic of	Inha University hospital	Incheon
Korea, Republic of	Inje University, Ilsan Paik Hospital	Koyang-si
Korea, Republic of	NHIC Ilsan hospital	Koyang-si
Korea, Republic of	Inje University, Pusan Paik Hospital	Pusan
Korea, Republic of	Seoul St. Mary's Hospital, The Catholic University of Korea	Seoul
Korea, Republic of	Ulsan university	Ulsan
Korea, Republic of	Yonsei University, Wonju Hospital	Wonju-si

Sponsors (12)

Lead Sponsor	Collaborator
The Catholic University of Korea	Chungnam National University, Hallym University Medical Center, Inha University Hospital, Inje University, Keimyung University, Konyang University Hospital, Kyungpook National University, NHIC Ilsan hospital, Soonchunhyang University Hospital, Ulsan University Hospital, Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained Virologic Response Depending on the Dosage of Peginterferon Alfa 2a	We investigate whether the SVR between 100% and 80% group of peginterferon alfa 2a is not different.	post treatment 24 weeks	Yes
Secondary	IL28B Polymorphism Effect on SVR	We additionally investigate the IL28B polymorphism and this result can effect on the SVR depending on dosage of peginterferon alfa-2a.	post treatment 24 weeks	No