Cyclosporine in Hepatitis C Infection Viral Clearance Following Liver Transplantation

NCT00821587 | Completed Phase 4 Results

• 1 other identifier: 20040658
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hepatitis C

Keywords

Hepatitis C Post Liver Transplant

Outcome Measures

Primary Outcomes (1)

• 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

  6 months after completion of interferon based therapy

Study Arms (2)

Tacrolimus

ACTIVE COMPARATOR

Tacrolimus

Drug: Tacrolimus

Cyclosporine

ACTIVE COMPARATOR

Cyclosporine

Drug: Cyclosporine

Interventions

Cyclosporine DRUG

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

Cyclosporine

Tacrolimus DRUG

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

Tacrolimus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• Novartis Pharmaceuticals: collaborator

MeSH Terms

Conditions

Hepatitis C

Interventions

Cyclosporine; Cyclosporins; Tacrolimus

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Roberto J. Firpi-Morell, MD
• Organization: University of Florida

firpirj@medicine.ufl.edu

352-273-9500

Study Officials

• Roberto J Firpi-Morell, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2009
• First Posted: January 13, 2009
• Study Start: June 1, 2004
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: June 1, 2023
• Results First Posted: December 8, 2011

Record last verified: 2023-05