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
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
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 2Virological 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.
Eligibility
Minimum age: 20 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
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
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