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

NCT01378104 | Completed Phase 4 Results DMC

• 1 other identifier: PEGASYS100:80
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 14

Brief Summary

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

Conditions

Sustained Virologic Response; IL28B Polymorphism

Keywords

reducing dose of peginterferon; chronic hepatitis c; Koreans; IL28B polymorphism

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• IL28B Polymorphism Effect on SVR

  post treatment 24 weeks

Study Arms (2)

80% dosage group of peginterferon alfa 2a

EXPERIMENTAL

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.

Drug: peginterferon alfa 2a (pegasys)

100% dosage group of peginterferon alfa 2a

ACTIVE COMPARATOR

These group patients would be treated with standard dose 180 ug/week for 48 weeks.

Drug: peginterferon alfa-2a (pegasys)

Interventions

peginterferon alfa 2a (pegasys) DRUG

dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable

Also known as: Roche

80% dosage group of peginterferon alfa 2a

peginterferon alfa-2a (pegasys) DRUG

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.

Also known as: Roche

100% dosage group of peginterferon alfa 2a

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Catholic University of Korea: lead
• Ulsan University Hospital: collaborator
• National Health Insurance Service Ilsan Hospital: collaborator
• Inje University: collaborator
• Soonchunhyang University Hospital: collaborator
• Yonsei University: collaborator
• Chungnam National University: collaborator
• Keimyung University: collaborator
• Kyungpook National University Hospital: collaborator
• Konyang University Hospital: collaborator
• Inha University Hospital: collaborator
• Hallym University Medical Center: collaborator

Study Sites (14)

Soonchunghyang University Hospital

Bucheon-si, South Korea

Location

Hallym University Chunchun Medical center

Chunchun, South Korea

Location

Keimyung University hospital

Daegu, South Korea

Location

Kyungpook National University Hospital

Daegu, South Korea

Location

Ghungnam National University hospital

Daejun, South Korea

Location

Konyang University hospital

Daejun, South Korea

Location

Incheon St. Mary's Hospital

Incheon, South Korea

Location

Inha University hospital

Incheon, South Korea

Location

Inje University, Ilsan Paik Hospital

Koyang-si, South Korea

Location

NHIC Ilsan hospital

Koyang-si, South Korea

Location

Inje University, Pusan Paik Hospital

Pusan, South Korea

Location

Seoul St. Mary's Hospital, The Catholic University of Korea

Seoul, South Korea

Location

Ulsan university

Ulsan, South Korea

Location

Yonsei University, Wonju Hospital

Wŏnju, South Korea

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Kwon
• Organization: the Catholic University of Korea

doctorkwon@catholic.ac.kr

+82322805886

Study Officials

• Jung Hyun Kwon, MD, Assistant professor

  The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: June 16, 2011
• First Posted: June 22, 2011
• Study Start: October 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2012
• Last Updated: March 8, 2013
• Results First Posted: March 8, 2013

Record last verified: 2013-02

Locations

KR (14)