Study of Liver Transplant For End-Stage Liver Disease Caused By Chronic Hepatitis C Infection

NCT00163657 | Completed Phase 4 Results DMC

• 2 other identifiers: 02-01-LZEN159
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare three treatment regimens in patients who have received a liver transplant for end-stage liver disease caused by Chronic Hepatitis C infection.

Conditions

End Stage Liver Disease; Hepatitis C

Keywords

Hepatitis C Virus; Immunosuppressive Agents

Outcome Measures

Primary Outcomes (2)

• Freedom From Acute Rejection or HCV Recurrence or Treatment Failure

  Freedom from acute rejection (Banff\>grade 2 with RAI score\>4) or freedom from HCV recurrence (Batts/Ludwig\>Stage 2, or \>Grade 3) that requires HCV antiviral therapy or treatment failure (patient death, graft loss, premature withdrawal from study regimen or treatment with more than 1 dose of corticosteroids for presumptive rejection without a biopsy to confirm the rejection; reported values represent the "Number of participants with Freedom From Acute Rejection or HCV Recurrence or Treatment Failure"

  12 months

• Freedom From HCV Recurrence Within First Year That Requires HCV Antiviral Therapy and Freedom From Treatment Failure

  Participants would have their blood drawn and tested for the HCV virus to determine if they had recurrence

  12 month post transplant

Study Arms (3)

tacrolimus and cyclosporine

ACTIVE COMPARATOR

immunosuppressant treatment regimens the intervention is antirejection treatment with the above labeled drugs tacrolimus and cyclosporine

Drug: Daclizumub; Drug: Tacrolimus

MMF, tacrolimus and cyclosporine

ACTIVE COMPARATOR

immunosuppressant treatment regimensthe intervention is antirejection treatment with the above labeled drugs MMF tacrolimus and cyclosporine

Drug: Tacrolimus; Drug: Cyclosporine; Drug: MMF

daclizumub, MMFand tacrolimus

ACTIVE COMPARATOR

immunosuppressant treatment regimens

Drug: Daclizumub; Drug: Tacrolimus; Drug: MMF

Interventions

Daclizumub DRUG

anti-rejection drug

Also known as: Zenapax

daclizumub, MMFand tacrolimus; tacrolimus and cyclosporine

Tacrolimus DRUG

anti rejection drug

Also known as: Prograf

MMF, tacrolimus and cyclosporine; daclizumub, MMFand tacrolimus; tacrolimus and cyclosporine

Cyclosporine DRUG

anti rejection drug

Also known as: Neoral

MMF, tacrolimus and cyclosporine

MMF DRUG

anti rejection drug

Also known as: mycophenolate mofetil

MMF, tacrolimus and cyclosporine; daclizumub, MMFand tacrolimus

Eligibility Criteria

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

You may qualify if:

• Patient has been fully informed and has signed an IRB approved informed consent form and is willing and able to follow study procedures for the full 2 years.
• Patient is a recipient of a primary whole/split, cadaveric/living donor liver transplant for end stage chronic Hepatitis C.
• Patient is \> age 18.
• Female patients of child bearing potential must have a negative urine or serum pregnancy test upon hospitalization or within 7 days prior to enrollment and have agreed to utilize effective birth control throughout the study as well as for 6 weeks following study completion.

You may not qualify if:

• Patient has previously received or is receiving an organ transplant other than a liver.
• Patient has received a liver transplant from a Hepatitis B core antibody or a Hepatitis C antibody positive donor.
• Patient has received an ABO (blood group anti A, anti B antibodies) incompatible donor liver.
• Patient has fulminant liver failure with a life expectancy without a liver transplant of less than 7 days as defined by UNOS (Adult Patient Status 1, UNOS Policy 3.6.4.1: See Appendix C).
• Patient has renal dysfunction pre-transplant that, in the opinion of the investigator, will prohibit the use of calcineurin inhibitors within 72 hours post transplant.
• Patient is intubated, on vasopressors, is ICU bound, or has experienced a significant blood loss (greater than 5 units) 72 hours prior to transplant procedure.
• Recipient or donor is seropositive for human immunodeficiency virus (HIV) or HbsAg positive serology.
• Patient is to receive antilymphocyte antibody induction therapy, such as ATGAM (lymphocyte immune globulin), OKT3 (muromonab-CD3), Simulect (basiliximab), or Thymoglobulin.
• Patient has a known hypersensitivity to Prograf (TAC), HCO-60, CellCept (MMF), Zenapax or corticosteroids.
• Patient is pregnant or lactating.
• Patient has participated in a blinded trial or participated in a trial involving a non-marketed (investigational) drug within 3 months of enrollment.
• Patient has participated in a trial involving a market drug within 30 days. However, patients who participated in any interferon or ribavirin trials are permitted.

Sponsors & Collaborators

• Baylor Research Institute: lead
• Baylor Health Care System: collaborator
• Emory University: collaborator
• University of Southern California: collaborator
• Mayo Clinic - Scottsdale/Phoenix, Arizona: collaborator
• New York Presbyterian Hospital: collaborator
• Oregon Health and Science University: collaborator
• New York University: collaborator
• University of Cincinnati: collaborator
• University of Alabama at Birmingham: collaborator
• The University of Texas Health Science Center at San Antonio: collaborator
• University of Chicago: collaborator
• University of California, San Francisco: collaborator
• Mayo Clinic - Rochester, Minnesota: collaborator
• Medical University of South Carolina: collaborator
• University of Virginia: collaborator
• Lahey Clinic: collaborator
• University of Medicine and Dentistry of New Jersey: collaborator
• Northwestern Memorial Hospital: collaborator

Study Sites (1)

Baylor Regional Transplant Institute - Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

End Stage Liver Disease; Hepatitis C

Interventions

Daclizumab; Tacrolimus; Cyclosporine; Mycophenolic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Macrolides; Lactones; Organic Chemicals; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids

Results Point of Contact

• Title: Goran Klintmalm, MD Director
• Organization: Baylor University Medical Center

michelle.acker@baylorhealth.edu

214-820-2050

Study Officials

• Goran Klintmalm, MD

  Baylor Univeristy Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

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: September 9, 2005
• First Posted: September 14, 2005
• Study Start: July 1, 2002
• Primary Completion: April 1, 2006
• Study Completion: January 1, 2007
• Last Updated: January 12, 2017
• Results First Posted: January 12, 2017

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)