An interventional study of Peginterferon alfa-2a plus Ribavirin in Chronic Hepatitis C, sponsored by Chang Gung Memorial Hospital. Terminated at 7 sites in Taiwan. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-07-29.
Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Supportive care
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
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.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's planned enrollment of 410 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.
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Exclusion Criteria:
Subjects with any of the following laboratory abnormalities
Drug: Peginterferon alfa-2a plus Ribavirin
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
Also known as: PEGASYS® plus ROBATROL®
Sustained virological response
Sustained virological response (SVR) defined as percentage of patients with HCV RNA \< 15 IU/ML as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test at 24 weeks post completion of the 36 or 48 week treatment periods.
Time frame: At 24 weeks after end of treatment
Virological Response Rate at week 2
Virological Response Rate at week 2 defined as the percentage of patients with HCV RNA \< 15 IU/ML as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV at 2 weeks post treatment.
Time frame: At treatment week 2
Virological response at end of treatment
Virological response at end of treatment defined as the percentage of patients with HCV RNA \< 15 IU/ML as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test after the last dose of study medication(± 28 days).
Time frame: At end of treatment
Correlation of virological response and SVR rate
Correlation of virological response (HCV RNA \< 15 IU/ML) at week 2 and SVR rate in each group.
Time frame: At 24 weeks after end of treatment
This study is terminated, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Chang Gung Memorial Hospital