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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Chronic Hepatitis C

Intervention / Treatment
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* Drug: Peginterferon alfa-2a plus Ribavirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20 70 years old Patients have never been treated with traditional interferon plus ribavirin or peginterferon plus ribarivin Chronic hepatitis C, genotype 1, HCV-RNA > 0.8x106 IU/ml, achieving RVR (undetectable HCV RNA at week 4) in the SoC treatment Patient must be able to comply with the assessments during the study Compensated liver disease (Child-Pugh Grade A clinical classification for patients with cirrhosis: total score ≦ 6) All fertile males and females receiving ribavirin must be using two forms of effective contraception during treatment with study drugs and 6 months post treatment completion Exclusion Criteria: 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) History or other evidence of decompensated liver disease Signs or symptoms of hepatocellular carcinoma Co-infection with hepatitis A, hepatitis B or human immunodeficiency virus (HIV) Not adequately controlled thyroid dysfunction, diabetes mellitus (HbA1c >8.5%) or psychiatric disorders, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease History of a severe seizure disorder or current anticonvulsant use History of immunologically mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration) or clinically relevant ophthalmological disorder (e.g. due to diabetes mellitus or hypertension) Women with on-going pregnancy or breast feeding Male partners of women who are pregnant Subjects with any of the following laboratory abnormalities Platelet count < 90,000/mm3 Absolute neutrophil count < 1,500 /mm3 Hemoglobin < 12 g/dL (F), 13 g/dL (M) Creatinine > ULN ALT and/or AST > 10X ULN Total serum bilirubin > 1.5 x ULN Inability or unwillingness to provide written informed consent or abide by the requirements of the study

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEGASYS® plus ROBATROL® for 36 weeks<br> | Drug: Peginterferon alfa-2a plus Ribavirin<br>* 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<br>* Other names: PEGASYS® plus ROBATROL®;|
| Active Comparator: PEGASYS® plus ROBATROL® for 48 weeks<br> | Drug: Peginterferon alfa-2a plus Ribavirin<br>* 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<br>* Other names: PEGASYS® plus ROBATROL®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At 24 weeks after end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 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. | At 24 weeks after end of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PEGASYS® PLUS RIBAVIRIN