A Phase 4 interventional study of Cyclosporine and Tacrolimus in Hepatitis C, sponsored by University of Florida. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-01.
Sponsored by University of Florida · Phase 4, Interventional, and Treatment
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.
This is a randomized, single-center controlled study comparing two different immunosuppression regimens (CsA and TAC) in patients with recurrent HCV after LT undergoing antiviral therapy for HCV.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 39 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Tacrolimus
Drug: Tacrolimus
Cyclosporine
Drug: Cyclosporine
Patients randomized to CsA had TAC discontinued and were treated with CsA at a dose of 2.0-4.0 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 150-200 ng/ml.
Also known as: Gengraf
Patients receiving TAC were treated with a dose of 0.08-0.12 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 10-15 ng/ml for the first month post-transplant followed by 5-10 ng/ml thereafter. Immunosuppression was typically tapered to monotherapy (TAC alone) within 4-6 months of transplantation.
Also known as: Prograf
Number of Participants With Less Than 100 Hepatitis C Virus RNA Copies/mL
Number of Participants with Undetectable or Less than 100 copies/ml Hepatitis C Viral Level --defined as SVR -Sustained Virologic Response
Time frame: 6 months after completion of interferon based therapy
The study was conducted at the University of Florida in Gainesville between July 2004 and April 2008. Patients attended clinic visits at the time of randomization (baseline) and at 12-week intervals for 72 weeks.
| Milestone | Tacrolimus | Cyclosporine |
|---|---|---|
| Started | 20 | 19 |
| Completed | 20 | 18 |
| Not completed | 0 | 1 |
| Withdrew: Physician decision | 0 | 1 |
Number of Participants with Undetectable or Less than 100 copies/ml Hepatitis C Viral Level --defined as SVR -Sustained Virologic Response
| Participants | Tacrolimus (TAC) | Cyclosporine (CsA) |
|---|---|---|
| Number of Participants With Less Than 100 Hepatitis C Virus RNA Copies/mL | 7 | 7 |
Collected over 72 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tacrolimus | — | 0/20 (0%) | 16/20 (80%) |
| Cyclosporine | — | 1/19 (5.3%) | 17/19 (89.5%) |
| Event | Tacrolimus | Cyclosporine |
|---|---|---|
| DeathImmune system disorders | 0/20 | 1/19 |
| Event | Tacrolimus | Cyclosporine |
|---|---|---|
| AnemiaBlood and lymphatic system disorders | 16/20 | 16/19 |
| ThrombocytopeniaBlood and lymphatic system disorders | 11/20 | 10/19 |
| DepressionPsychiatric disorders | 8/20 | 9/19 |
| InsomniaGeneral disorders | 6/20 | 9/19 |
| NeutropeniaBlood and lymphatic system disorders | 8/20 | 3/19 |
| NauseaGastrointestinal disorders | 5/20 | 5/19 |
| FeverGeneral disorders | 4/20 | 4/19 |
| IrritabilityPsychiatric disorders | 2/20 | 3/19 |
| Age, Categorical(Participants) | Tacrolimus | Cyclosporine | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 20 | 19 | 39 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Tacrolimus | Cyclosporine | Total |
|---|---|---|---|
| Mean | 54.4 ± 5.4 | 52.2 ± 6.4 | 53.3 ± 5.9 |
| Sex: Female, Male(Participants) | Tacrolimus | Cyclosporine | Total |
|---|---|---|---|
| Female | 2 | 5 | 7 |
| Male | 18 | 14 | 32 |
| Region of Enrollment(participants) | Tacrolimus | Cyclosporine | Total |
|---|---|---|---|
| United States | 20 | 19 | 39 |
No study locations are listed for this record.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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University of Florida