DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: The Catholic University of Korea
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sustained Virologic Response; IL28B Polymorphism

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

Phase: Phase 4

Status: Completed

Sponsored by: The Catholic University of Korea

Official(s) and/or principal investigator(s):
Jung Hyun Kwon, MD, Assistant professor, Principal Investigator, Affiliation: The Catholic University of Korea

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

Clinical Details

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%

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

Primary outcome: Sustained Virologic Response Depending on the Dosage of Peginterferon Alfa 2a

Secondary outcome: IL28B Polymorphism Effect on SVR

Detailed 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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

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, Korea, Republic of

Additional Information

Starting date: October 2008
Last updated: February 3, 2013

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017