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

Information source: Chang Gung Memorial Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Hepatitis C

Intervention: Peginterferon alfa-2a plus Ribavirin (Drug)

Phase: N/A

Status: Terminated

Sponsored by: Chang Gung Memorial Hospital

Official(s) and/or principal investigator(s):
I-Shyan Sheen, M.D., Principal Investigator, Affiliation: Linkou Medical Center, Chang Gung Memorial Hospital


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

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome: Sustained virological response

Secondary outcome:

Virological Response Rate at week 2

Virological response at end of treatment

Correlation of virological response and SVR rate

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.


Minimum age: 20 Years. Maximum age: 70 Years. Gender(s): Both.


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

Locations and Contacts

Show Chwan Memorial Hospital, Changhua City 500, Taiwan

Changhua Christian Hospital, Changhua County 500, Taiwan

Keelung Chang Gung Memorial Hospital, Keelung City 222, Taiwan

China Medical University Hospital, Taichung City 404, Taiwan

Tungs' Taichung MetroHarbor Hospital, Taichung City 435, Taiwan

Taipei Medical University - Shuang Ho Hospital, Taipei County 235, Taiwan

Linkou Medical Center, Chang Gung Memorial Hospital, Taoyuan County 333, Taiwan

Additional Information

Starting date: July 2012
Last updated: July 27, 2015

Page last updated: August 23, 2015

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