NCT01639547

Sustained Virological Response (SVR)Rate of Pegasys Plus Ribavirin in Patients With Chronic Hepatitis C

A Randomized, Open-lable, Multicenter, Parallel Group Study to Compare SVR Rate of Pegasys Plus Ribavirin for 48 Weeks vs. 36 Weeks in Patients With Chronic Hepatitis C

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 410 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effect of PEGASYS® (peginterferon alfa-2a 40KD) plus Robatrol® (ribavirin) combination therapy given for 36 weeks versus 48 weeks on the clearance of HCV viremia 24 weeks after treatment end

Detailed description

Pegylated interferon plus ribavirin brings a good therapeutic response and curability. However, the adverse effects and sufferings are lots. Response-guided, personalized treatment is current principle. In patients of CHC, GT1 PR treatment for 24 weeks is established in rapid virologic responders (RVR) who have low viral load before treatment. As to patients with RVR but high viral load (HVL), the treatment duration is 48 weeks that is the same as patients with complete early virologic response (cEVR). Is a shorter duration of treatment feasible for those with a good virokinetic response? The ideal treatment duration for patients of chronic hepatitis C, GT-1, high viral load with RVR has had no enough data yet. Is it really necessary to double the treatment duration (48 weeks) for patients of chronic hepatitis C, GT-1, high viral load with RVR? Is 36-week adequate for them? A multicenter trial of INDIV-2 was presented at EASL 2010. They treated CHC patients of naïve GT1 HVL and RVR for 30 weeks and got similarly good SVR as those treated for 48 weeks (85% vs. 82%). Therefore, investigators design a randomized controlled study to investigate the SVR rates between treatment for 36 weeks and for 48 weeks in patients of CHC, GT1, HVL and RVR.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	Peginterferon alfa-2a plus Ribavirin	Peginterferon alfa-2a(pre-filled syringes 180 mcg/0.5 ml once a week) plus ribavirin(200 mg/Capsules, 1000\~1200 mg daily in split doses (morning/evening)) for 36 or 48 weeks

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2012-07-12
• Last updated: 2015-07-29

Locations

7 sites across 1 country: Taiwan