A Phase 4 interventional study of A: Peg-interferon alpha-2a & Ribavirin and B: Peg-interferon alpha-2a & Ribavirin in Hepatitis C, sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-29.
Sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital · Phase 4, Interventional, and Treatment
The purposes of this study are:
The aims of the present study are:
2,356 studies on the registry are indexed under Hepatitis C; 101 are open to participants now.
This study's enrollment of 542 is above the median of 79 across 1,660 interventional studies indexed under Hepatitis C.
Browse Hepatitis C studies →Kaohsiung Medical University Chung-Ho Memorial Hospital is the lead sponsor of 288 studies on the registry; 57 are open to participants now.
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Exclusion Criteria:
Arm A: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 24 weeks with a follow-up period of 24 weeks.
Drug: A: 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)
Drug: B: 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)
Drug: C: 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)
Drug: D: 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)
Drug: E: 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)
Drug: F: 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.
Also known as: Pegasys & Robatrol
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.
Also known as: Pegasys & Robatrol
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.
Also known as: Pegasys, Robatrol
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.
Also known as: PEGASYS, Robatrol
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.
Also known as: Pegasys, Robatrol
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.
Also known as: Pegasys, Robatrol
Efficacy
Rapid virologic response (RVR), HCV RNA seronegative by PCR at week 4 Sustained virological response (SVR), HCV RNA seronegative by PCR throughout 24-week off-treatment period
Time frame: 24-week off-treatment period
Safety
adverse event rate and profile
Time frame: 24-week off-treatment period
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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Kaohsiung Medical University Chung-Ho Memorial Hospital →