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

NCT01937728 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 542

Last updated 2016-12-29

No results posted yet for this study

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

Conditions

  • Hepatitis C

Interventions

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    lead OTHER

Principal Investigators

  • Chia-Yen Dai, M.D., PhD. · Kaohsiung Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2016-10-31
Completion
2016-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01937728 on ClinicalTrials.gov