Orthotopic Liver Transplant (OLT) Recipients With Hepatitis C Virus (HCV) Under Preemptive Treatment

NCT00167557 | Withdrawn Phase 4

• 3 other identifiers: HSC-MS-04-0346Astellas PharmaFHIprojectno.JK-04-002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

After a liver transplant, the hepatitis C virus (which destroyed one's own liver) eventually comes back. In many patients, this will eventually cause the loss of the new liver and can also confuse the doctors taking care of them because it is hard to tell the difference between one's body rejecting the new liver and hepatitis. This can cause serious treatment errors that can lead to more severe hepatitis or to rejection of the liver. Some of the drugs used to prevent rejection of one's new liver can cause the hepatitis to come back in a more severe form. This is especially true for the drugs known as corticosteroids. Right now, the only effective treatment against hepatitis C is a combination of two drugs called interferon and ribavirin. These drugs act by strengthening one's immune system to fight the virus and by directly reducing the reproduction of the virus. Because the treatment with these drugs is associated with many side effects, there is little experience with treating patients after liver transplantation with them. In the investigators' transplant program, they have decided to treat all patients with hepatitis C as early as possible after transplantation and to follow them closely for the development of hepatitis and side effects of the treatment. The investigators treat one's hepatitis as early as possible, before any actual damage has occurred in the new liver. This approach has been tried before but it has been hard to tell if it has worked or not. The main reason for failure was that many patients could not complete the treatment due to side effects. The investigators' purpose is to treat those side effects aggressively so that most patients can complete the treatment course. The purpose of this study is to collect all the data regarding the investigators' treatment protocol so that they will be able to learn if this form of treatment is beneficial. The study includes performing liver biopsies at scheduled times after one's liver transplant and for scheduled blood tests to see how much virus is still in the blood. If patients show signs that they are not responding to treatment they will be removed from the study.

Conditions

Hepatitis C

Keywords

Liver Transplantation

Outcome Measures

Primary Outcomes (1)

• Viral clearance after liver transplantation

  3 yrs. post liver transplant

Secondary Outcomes (2)

• histological progression of fibrosis and inflammation

  3 yrs. post liver transplant

• rate of rejection on HCV treatment

  3 yrs post liver transplant

Study Arms (1)

Single Arm Study

EXPERIMENTAL

Drug: Pegylated Interferon; Drug: Ribavirin; Procedure: Liver Biopsy

Interventions

Pegylated Interferon DRUG

180mcg SC weekly starting 30 days post transplant

Single Arm Study

Ribavirin DRUG

goal dose 13mg/kg starting 120 days post transplant for a minimum of 48 wks

Single Arm Study

Liver Biopsy PROCEDURE

Liver biopsies performed at 9 points in time from time of liver transplant

Single Arm Study

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male or female patients between 18 and 70 years of age
• All liver transplant patients with a positive HCV RNA by PCR within 30 days after transplant.
• No evidence of acute or chronic rejection within 4 weeks of enrollment
• Compensated liver disease according to the following criteria:
• Hemoglobin \> 10 gm/dL;
• Neutrophil count \> 1,000/mm3;
• Platelet count \> 50,000/mm3;
• Serum creatinine \< 2.0 mg/dL.
• Documentation of adequate contraception in females and males sexually active or of childbearing potential.

You may not qualify if:

• Hypersensitivity to alpha interferon and/or ribavirin
• Previous treatment with interferon and/or ribavirin post liver transplantation
• HIV
• Autoimmune hepatitis
• Active alcohol or substance abuse
• Non compliance
• Hemoglobinopathies or hemolytic anemia
• Clinical significant retinal abnormalities
• Decompensated cardio-vascular, endocrine, pulmonary, renal, immune, metabolic, dermatologic or psychiatric illness
• Re-transplantation

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Astellas Pharma US, Inc.: collaborator

Study Sites (1)

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

Ribavirin

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)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Hadar J Merhav, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 14, 2005
• Study Start: January 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: November 19, 2013

Record last verified: 2013-11

Locations

US (1)