Inhibition of Disease Progression in Hepatitis C-infected Patients With Compensated Liver Cirrhos… (NCT00811967) | Clinical Trial Compass
TerminatedPhase 3
Inhibition of Disease Progression in Hepatitis C-infected Patients With Compensated Liver Cirrhosis (P03811) (COMPLETED)
50 participantsStarted 2003-02
Plain-language summary
The objective of the study is to evaluate the superiority of treatment with PegIntron and Rebetol over no antiviral therapy (control group) in subjects with chronic hepatitis C and type C compensated cirrhosis. Subjects will be randomized in a ratio of 2:1 (Treatment Arm to Control Arm). Subjects in the Treatment Arm will receive combination therapy with PegIntron and Rebetol for 48 weeks; then will enter a 24-week post-treatment Follow-up. Subjects who have detectable Hepatitis C Virus-RNA at Treatment Week 24 will discontinue treatment and enter Follow-up.
Who can participate
Age range
20 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Patients with compensated hepatic cirrhosis secondary to chronic hepatitis C who would meet all the inclusion criteria below and would not interfere with any of the exclusion criteria below.
* Patients (regardless of gender) who can take contraceptive measures from date of informed consent to the end of follow-up
* Patients who meet all the criteria below in the test/observation/ investigation in 30 days before the beginning of treatment.
* Patients with quantitative HCV-RNA (+)
* ALT \> 40 IU/L
* Patients who are classified as Child-Pugh Classification A, and who do not have ascites or hepatic encephalopathy
* Prothrombin Time \<=3.0 seconds prolonged, total bilirubin \<= 1.5 mg/dL or direct bilirubin \<= 0.7 mg/dL, Albumin \>= 3.0 g/dL
* AFP within normal limits, AFP-L3 \<= 10%,PIVKA-II \<= 100 mAU/mL
* Serum creatinine \<= upper limit of normal, creatinine clearance \>= 51 mL/minute
* Patients with fasting blood glucose \< 110 mg/dL.
* Thyroid-stimulating hormone within normal limits
* Hemoglobin level \>= 12 g/dL,leukocyte count \>= 3,000/mm3,neutrophil count \>= 1,500 /mm3,platelet count \>= 80,000/mm3
* Patients who weighs more than 40 kg and not more than 100 kg within 60 days prior to registration
* Patients who were diagnosed with liver cirrhosis (fibrosis score: F4) based on the liver biopsy performed within a year prior to registration and is able to provide with liver tissue sample.
* Patients who between the ages of 20 and…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sustained virologic response rate, defined as the proportion of subjects with undetectable HCV-RNA at 24-week post-treatment follow-up