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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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