PegIFN Alfa-2a and RBV for 16 or 24 Weeks in Patients With Chronic Hepatitis C(CHC) 2 With Rapid Virologic Response(RVR)

NCT01056172 | Unknown Phase 4 DMC

• 1 other identifier: PNUYH-CHC001
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 8

Brief Summary

This study aim to evaluate the non-inferiority of sustained virologic response in peginterferon alfa-2a and weight-based ribavirin for 16 weeks compare with standard treatment duration of 24 weeks in patients who achieved rapid virologic response with genotype 2 CHC.

Conditions

Chronic Hepatitis C

Keywords

Chronic hepatitis C; Genotype 2; Rapid virologic response; Sustained virologic response; Peginterferon alfa-2a; Ribavirin

Outcome Measures

Primary Outcomes (1)

• Sustained virologic response (SVR)

  24 weeks post-treatment (week 40 or week 48)

Secondary Outcomes (3)

• AEs

  up to 24 weeks after last treatment visit

• laboratory parameters

  up to 24 weeks after last treatment visit

• vital signs

  up to 24 weeks after last treatment visit

Study Arms (2)

A. 24 weeks in RVR patients.

ACTIVE COMPARATOR

Peginterferon alfa-2a and weight-based ribavirin (800-1200mg/day) for 24 weeks in patients with RVR.

Drug: Peginterferon alfa-2a and Ribavirin

B. 16 weeks in RVR patients.

EXPERIMENTAL

Peginterferon alfa-2a and weight-based ribavirin (800-1200mg/day) for 16 weeks in patients with RVR.

Drug: Peginterferon alfa-2a and Ribavirin

Interventions

Peginterferon alfa-2a and Ribavirin DRUG

1. PegIFN alfa-2a (PEgasys) 180 ug/week 2. Weight-based ribavirin (\<65kg: 800mg/day, 65-85kg: 1000mg/day, \>85kg: 1200mg/day) 3. Treatment duration: 16 weeks

B. 16 weeks in RVR patients.

Eligibility Criteria

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

You may qualify if:

• Age older than 18 years old
• Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
• Detectable serum quantitative HCV-RNA
• HCV genotype 2 (VERSANT HCV Genotype Assay (LIPA))
• Patients have never been treated with traditional interferon plus ribavirin or peginterferon plus ribavirin

You may not qualify if:

• Co-infection with hepatitis B and/or human immunodeficiency virus (HIV)
• History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
• Decompensated liver disease (Child-Pugh class B or C)
• Neoplastic disease within 5 years
• Evidence of drug abuse (including excessive alcohol consumption) within one year of study entry
• Women with ongoing pregnancy or breast feeding
• Hgb \< 11 g/dL in women or \< 12 g/dL in men at screening
• Neutrophil count \< 1500 cells/mm3 or platelet count \< 90,000 cells/mm3 at screening
• Serum creatinine level \> 1.5 times the upper limit of normal at screening
• Serum alpha-fetoprotein \> 100 ng/mL
• History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease
• History of immunologically mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
• History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
• History of a severe seizure disorder or current anticonvulsant use
• Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration)

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead
• Severance Hospital: collaborator
• Pusan National University Hospital: collaborator
• Incheon St.Mary's Hospital: collaborator
• Soon Chun Hyang University: collaborator
• Inje University: collaborator
• Inje University Ilsan Paik Hospital: collaborator
• Inje University Haeundae Paik Hospital: collaborator

Study Sites (8)

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 626-770, South Korea

RECRUITING

Soon Chun Hyang University Bucheon Hospital

Bucheon-si, 420-767, South Korea

RECRUITING

Pusan National University Hospital

Busan, 602-739, South Korea

RECRUITING

Inje University Pusan Paik Hospital

Busan, 633-165, South Korea

RECRUITING

Inje University Haeundae Paik Hospital

Busan, South Korea

RECRUITING

Inje University Ilsan Paik Hospital

Goyang, South Korea

ACTIVE NOT RECRUITING

Incheon St. Mary's Hospital

Incheon, South Korea

RECRUITING

Severance Hospital

Seoul, 120-752, South Korea

RECRUITING

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2a; Ribavirin

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

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Ki Tae Yoon, M.D

  Pusan National University Yangsan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ki Tae Yoon, M.D

CONTACT

+82-55-360-2362; ktyoon@pusan.ac.kr

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: January 25, 2010
• First Posted: January 26, 2010
• Study Start: January 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 20, 2012

Record last verified: 2012-04

Locations

KR (8)