Cyclosporine in Hepatitis C Infection Viral Clearance Following Liver Transplantation (NCT00821587) | Clinical Trial Compass
CompletedPhase 4
Cyclosporine in Hepatitis C Infection Viral Clearance Following Liver Transplantation
39 participantsStarted 2004-06
Plain-language summary
The purpose of this study is to evaluate the effect of cyclosporine, an anti-rejection drug, on the clearance of the hepatitis C virus in liver transplant subjects being treated with peg-interferon and ribavirin.
Who can participate
Age range
18 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:
* Males and females age 18 years and older
* HCV RNA positive by PCR after liver transplantation
* Elevated ALT at any time point after liver transplantation
* Protocol liver biopsy (standard of care) consistent with Stage greater than or equal to 2 of Ishak fibrosis score after liver transplantation
* Able to provide written informed consent
* Willing to practice acceptable birth control during the study period.
Exclusion Criteria:
* Decompensated Cirrhosis
* hemoglobin \< 12 g/dl
* WBC \< 3,500/cubic mm
* Platelets \< 75,000/cubic mm
* Human immunodeficiency virus infection
* Pregnancy
* Positive HbsAg
* History of coronary artery disease, history of seizure disorder, poorly controlled autoimmune conditions, thyroid dysfunction, diabetes mellitus, major psychosis, intolerance to previous interferon-based therapy other than anemia or neutropenia
* History of suicidal ideation or suicidal attempts
* Creatinine \> 2.0 mg/dl
* Severe non-hepatic illnesses
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
Number of Participants With Less Than 100 Hepatitis C Virus RNA Copies/mL
Timeframe: 6 months after completion of interferon based therapy