Tailored Regimens of PEGASYS® and Ribavirin for Genotype 1 Chronic Hepatitis C Patients Trial (TARGET-1)
NCT ID: NCT01937728
Last Updated: 2016-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
542 participants
INTERVENTIONAL
2010-03-31
2016-12-31
Brief Summary
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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
Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A: Peg-interferon alpha-2a & Ribavirin
Arm A: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 24 weeks with a follow-up period of 24 weeks.
A: Peg-interferon alpha-2a & Ribavirin
Arm A: Patients who have low viral loads (LVL, defined as baseline HCV RNA \< 400,000 IU/mL) and RVR will be treated with PEGASYS 180ug/week and Ribavirin 1000-1200 mg/day for 24 weeks with a follow-up period of 24 weeks.
B: Peg-interferon alpha-2a & Ribavirin
Arm B: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 36 weeks with a follow-up period of 24 weeks.
(Patients who have HVL and an RVR will be randomized into arm B or arm C with a ratio of 1:1)
B: Peg-interferon alpha-2a & Ribavirin
Patients who have HVL and an RVR will be randomized into arm B or arm C with a ratio of 1:1.
Arm B: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 36 weeks with a follow-up period of 24 weeks.
C: Peg-interferon alpha-2a & Ribavirin
Arm C: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 48 weeks with a follow-up period of 24 weeks.
(Patients who have HVL and an RVR will be randomized into arm B or arm C with a ratio of 1:1)
C: Peg-interferon alpha-2a & Ribavirin
Patients who have HVL and an RVR will be randomized into arm B or arm C with a ratio of 1:1.
Arm C: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 48 weeks with a follow-up period of 24 weeks.
D: Peg-interferon alpha-2a & Ribavirin
Arm D: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 48 weeks with a follow-up period of 24 weeks.
(Patients who do not achieve a RVR but have HCV RNA PCR-seronegative at week 12 of treatment)
D: Peg-interferon alpha-2a & Ribavirin
Arm D: Patients who do not achieve a RVR but have HCV RNA PCR-seronegative at week 12 of treatment will be treated with PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 48 weeks with a follow-up period of 24 weeks.
E: Peg-interferon alpha-2a & Ribavirin
Arm E: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 48 weeks with a follow-up period of 24 weeks.
(Patients who do not achieve a RVR and remain HCV RNA PCR-seropositive at week 12 of treatment will be randomized into arm E or arm F a ratio of 1:1)
E: Peg-interferon alpha-2a & Ribavirin
Patients who do not achieve a RVR and remain HCV RNA PCR-seropositive at week 12 of treatment will be randomized into arm E or arm F with a ratio of 1:1.
Arm E: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 48 weeks with a follow-up period of 24 weeks.
F: Peg-interferon alpha-2a & Ribavirin
Arm F: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 72 weeks with a follow-up period of 24 weeks.
(Patients who do not achieve a RVR and remain HCV RNA PCR-seropositive at week 12 of treatment will be randomized into arm E or arm F a ratio of 1:1)
F: Peg-interferon alpha-2a & Ribavirin
Patients who do not achieve a RVR and remain HCV RNA PCR-seropositive at week 12 of treatment will be randomized into arm E or arm F with a ratio of 1:1.
Arm F: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 72 weeks with a follow-up period of 24 weeks.
Interventions
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A: Peg-interferon alpha-2a & Ribavirin
Arm A: Patients who have low viral loads (LVL, defined as baseline HCV RNA \< 400,000 IU/mL) and RVR will be treated with PEGASYS 180ug/week and Ribavirin 1000-1200 mg/day for 24 weeks with a follow-up period of 24 weeks.
B: Peg-interferon alpha-2a & Ribavirin
Patients who have HVL and an RVR will be randomized into arm B or arm C with a ratio of 1:1.
Arm B: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 36 weeks with a follow-up period of 24 weeks.
C: Peg-interferon alpha-2a & Ribavirin
Patients who have HVL and an RVR will be randomized into arm B or arm C with a ratio of 1:1.
Arm C: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 48 weeks with a follow-up period of 24 weeks.
D: Peg-interferon alpha-2a & Ribavirin
Arm D: Patients who do not achieve a RVR but have HCV RNA PCR-seronegative at week 12 of treatment will be treated with PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 48 weeks with a follow-up period of 24 weeks.
E: Peg-interferon alpha-2a & Ribavirin
Patients who do not achieve a RVR and remain HCV RNA PCR-seropositive at week 12 of treatment will be randomized into arm E or arm F with a ratio of 1:1.
Arm E: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 48 weeks with a follow-up period of 24 weeks.
F: Peg-interferon alpha-2a & Ribavirin
Patients who do not achieve a RVR and remain HCV RNA PCR-seropositive at week 12 of treatment will be randomized into arm E or arm F with a ratio of 1:1.
Arm F: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 72 weeks with a follow-up period of 24 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Kaohsiung Medical University Chung-Ho Memorial Hospital
OTHER
Responsible Party
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Chia-Yen Dai
Professor, School of Medicine, Hepatology Division
Principal Investigators
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Chia-Yen Dai, M.D., PhD.
Role: PRINCIPAL_INVESTIGATOR
Kaohsiung Medical University
Locations
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Kaohsiung Medical University Hospital
Kaohsiung City, , Taiwan
Countries
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Other Identifiers
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KMUH-IRB-970119
Identifier Type: -
Identifier Source: org_study_id