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

NCT ID: NCT01639547

Last Updated: 2015-07-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 410 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2014-07-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

PEGASYS® plus ROBATROL® for 36 weeks

Group Type: EXPERIMENTAL

Peginterferon alfa-2a plus Ribavirin

Intervention Type: DRUG

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

PEGASYS® plus ROBATROL® for 48 weeks

Group Type: ACTIVE_COMPARATOR

Peginterferon alfa-2a plus Ribavirin

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

PEGASYS® plus ROBATROL®

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

I-Shyan Sheen

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

I-Shyan Sheen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Linkou Medical Center, Chang Gung Memorial Hospital

Locations

Show Chwan Memorial Hospital

Changhua, , Taiwan

Changhua Christian Hospital

Changhua County, , Taiwan

Keelung Chang Gung Memorial Hospital

Keelung, , Taiwan

China Medical University Hospital

Taichung, , Taiwan

Tungs' Taichung MetroHarbor Hospital

Taichung, , Taiwan

Taipei Medical University - Shuang Ho Hospital

Taipei County, , Taiwan

Linkou Medical Center, Chang Gung Memorial Hospital

Taoyuan, , Taiwan

Countries

Taiwan

Other Identifiers

CTC-133

Identifier Type: -

Identifier Source: org_study_id