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
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