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

Chronic Hepatitis C Clinical Trial

Official title:

A Prospective Randomized, Open Labeled, Phase IV, Multicenter Study for Peginterferon Alfa-2a and Weight-based Ribavirin for 16 or 24 Weeks in genotype2 Chronic Hepatitis C Patients Who Achieved Rapid Virologic Response

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01056172
• Other study ID #: PNUYH-CHC001
• Status: Recruiting
• Phase: Phase 4
• First received: January 25, 2010
• Last updated: April 18, 2012
• Start date: January 2010
• Est. completion date: December 2012

Study information

• Verified date: April 2012
• Source: Pusan National University Yangsan Hospital
• Contact: Ki Tae Yoon, M.D
• Phone: +82-55-360-2362
• Email: ktyoon[@]pusan.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

In recent study (the ACCELERATE trial), treatment with peginterferon alfa-2a and ribavirin (800mg/day) for 16 weeks in patients infected with HCV genotype 2 or 3 result in a lower overall sustained virologic response rate than treatment with the standard 24 weeks regimen. Ribavirin was used as a flat dose (800mg/day) in ACCELERATE trial. But, previous studies which used the weight-based dose of ribavirin (800-1400mg/day) had shown that a treatment duration of 16 weeks was as effective as 24 weeks regimen in HCV genotype 2 patients with a RVR. But, there was too small number of patient enrolled study to argue logically about ACCELERATE trial. In this study, we aimed to confirm the non-inferiority 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 164
• Est. completion date: December 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age older than 18 years old

2. Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test

3. Detectable serum quantitative HCV-RNA

4. HCV genotype 2 (VERSANT HCV Genotype Assay (LIPA))

5. Patients have never been treated with traditional interferon plus ribavirin or peginterferon plus ribavirin

Exclusion Criteria:

1. Co-infection with hepatitis B and/or human immunodeficiency virus (HIV)

2. 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)

3. Decompensated liver disease (Child-Pugh class B or C)

4. Neoplastic disease within 5 years

5. Evidence of drug abuse (including excessive alcohol consumption) within one year of study entry

6. Women with ongoing pregnancy or breast feeding

7. Hgb < 11 g/dL in women or < 12 g/dL in men at screening

8. Neutrophil count < 1500 cells/mm3 or platelet count < 90,000 cells/mm3 at screening

9. Serum creatinine level > 1.5 times the upper limit of normal at screening

10. Serum alpha-fetoprotein > 100 ng/mL

11. 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

12. 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

13. History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease

14. History of a severe seizure disorder or current anticonvulsant use

15. Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration)

16. Inability or unwillingness to provide informed consent or abide by the requirements of the study

Study Design

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

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Peginterferon alfa-2a and Ribavirin
PegIFN alfa-2a (PEgasys) 180 ug/week Weight-based ribavirin (<65kg: 800mg/day, 65-85kg: 1000mg/day, >85kg: 1200mg/day) Treatment duration: 16 weeks
• Peginterferon alfa-2a and Ribavirin
PegIFN alfa-2a (PEgasys) 180 ug/week Weight-based ribavirin (<65kg: 800mg/day, 65-85kg: 1000mg/day, >85kg: 1200mg/day) Treatment duration: 24 weeks

Locations

Country	Name	City	State
Korea, Republic of	Soon Chun Hyang University Bucheon Hospital	Bucheon
Korea, Republic of	Inje University Haeundae Paik Hospital	Busan
Korea, Republic of	Inje University Pusan Paik Hospital	Busan
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Inje University Ilsan Paik Hospital	Goyang
Korea, Republic of	Incheon St. Mary's Hospital	Incheon
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan	Gyeongnam

Sponsors (6)

Lead Sponsor	Collaborator
Pusan National University Yangsan Hospital	Incheon St.Mary's Hospital, Inje University, Pusan National University Hospital, Severance Hospital, Soon Chun Hyang University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained virologic response (SVR)		24 weeks post-treatment (week 40 or week 48)	No
Secondary	AEs	16 weeks treatment arm: 40 weeks; 24 weeks treatment arm: 48 weeks	up to 24 weeks after last treatment visit	No
Secondary	laboratory parameters	16 weeks treatment arm: 40 weeks; 24 weeks treatment arm: 48 weeks	up to 24 weeks after last treatment visit	No
Secondary	vital signs	16 weeks treatment arm: 40 weeks; 24 weeks treatment arm: 48 weeks	up to 24 weeks after last treatment visit	No