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Tailored Regimens of PEGASYS® and Ribavirin for Genotype 1 Chronic Hepatitis C Patients Trial (TARGET-1)

Information source: Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C

Intervention: A: Peg-interferon alpha-2a & Ribavirin (Drug); B: Peg-interferon alpha-2a & Ribavirin (Drug); C: Peg-interferon alpha-2a & Ribavirin (Drug); D: Peg-interferon alpha-2a & Ribavirin (Drug); E: Peg-interferon alpha-2a & Ribavirin (Drug); F: Peg-interferon alpha-2a & Ribavirin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Kaohsiung Medical University Chung-Ho Memorial Hospital

Official(s) and/or principal investigator(s):
Chia-Yen Dai, M.D., PhD., Principal Investigator, Affiliation: Kaohsiung Medical University

Overall contact:
Chia-Yen Dai, Phone: 886 7-312 1101, Ext: 7475, Email: research.kmuhb@gmail.com

Summary

The purposes of this study are: 1. To test if 36 weeks of standard dose of ribavirin with PEGASYS® is non-inferior to standard dose of 48 weeks of ribavirin with PEGASYS® in SVR for patients with RVR and HVL 2. To test if the 72 weeks of treatment with PEGASYS® plus standard dose ribavirin is superior to 48 weeks of the same treatment for patients with HCV RNA seropositivity at week 12

Clinical Details

Official title: A Randomized, Multicenter, Open Label Study Evaluating the Efficacy and Safety of Tailored Regimens With Peginterferon Alfa-2a Plus Ribavirin According Viral Kinetics for Genotype 1 Chronic Hepatitis C Patients

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

Primary outcome: Efficacy

Secondary outcome: Safety

Detailed description: The aims of the present study are: 1. To evaluate the efficacy and safety of 36-week versus 48-week regimen of PEGASYS® (peginterferon alfa-2a, PegIFN) plus standard-dose of ribavirin (RBV) in hepatitis C virus (HCV) genotype 1 infected, treatment-naïve CHC patients who have high viral loads (HVL, defined as baseline HCV RNA ≧ 400,000 IU/mL) and achieve a rapid virologic response (RVR) (defined as seronegativity of HCV RNA at week 4 of treatment) 2. To evaluate the efficacy and safety of 48-week versus 72-week regimen of PegIFN plus standard-dose of RBV in HCV virus genotype 1 infected, treatment-naïve CHC patients with PCR-seropositive of HCV RNA at week 12

Eligibility

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

Criteria:

Inclusion Criteria:

- Male and female patients *18 years of age

- Patients have never been treated with traditional interferon plus ribavirin or

peginterferon plus ribavirin

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

- Detectable serum HCV-RNA and HCV viral genotype 1

- Liver biopsy findings consistent with the diagnosis of chronic hepatitis C infection

with or without compensated cirrhosis (Exception: hemophiliacs in whom biopsy is medically contra-indicated do not require biopsy.)

- Compensated liver disease (Child-Pugh Grade A clinical classification)

- Negative urine or blood pregnancy test (for women of childbearing potential)

documented within the 24-hour period prior to the first dose of study drug

- All fertile males and females receiving ribavirin must be using two forms of

effective contraception during treatment and during the 6 months after treatment end Exclusion Criteria:

- Women with ongoing pregnancy or breast feeding

- Therapy with any systemic anti-neoplastic or immunomodulatory treatment (including

supraphysiologic doses of steroids and radiation) *6 months prior to the first dose of study drug

- Any investigational drug *6 weeks prior to the first dose of study drug

- Co-infection with active hepatitis A, 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)

- Signs or symptoms of hepatocellular carcinoma

- History or other evidence of bleeding from esophageal varices or other conditions

consistent with decompensated liver disease

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

Locations and Contacts

Chia-Yen Dai, Phone: 886 7-312 1101, Ext: 7475, Email: research.kmuhb@gmail.com

Kaohsiung Medical University Hospital, Kaohsiung, Taiwan; Recruiting
Chia-Yen Dai, Phone: 886 7-312 1101, Ext: 7475, Email: daichiayen@gmail.com
Additional Information

Starting date: March 2010
Last updated: September 4, 2013

Page last updated: August 23, 2015

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