Clinical trial NCT01074203: A Pilot Study to Examine the Role of Nitazoxanide to Prevent Recurrence of Hepatitis C After Transplantation
Official title: A Pilot Study to Explore a Potential Role of Nitazoxanide (NTZ) in the Prevention of Recurrent Hepatitis C Virus (HCV) Infection After Orthotopic Liver Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C Recurrence
Keywords: nitazoxanide
liver transplantation
HCV recurrence
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2010-02-24
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Recurrence of Hepatitis C virus infection (HCV) is universal after orthotopic liver transplantation (LTx) and is associated with allograft failure, death and need for re-transplantation. Currently, there are no effective therapies to prevent HCV recurrence. Nitazoxanide (NTZ), an oral thiazolide anti-infectious agent, was safe, well tolerated and effective in achieving sustained viral response in patients with chronic HCV genotype 4. Its role in the prevention of HCV recurrence after liver transplantation has not been studied. The investigators propose to conduct an open label pilot study examining the role of NTZ in the prevention of HCV re-infection in eight patients undergoing LTx. First time transplant recipients for chronic HCV without history of renal failure or HIV/HBV co-infection, will receive NTZ immediately prior to LTx and for 3 days thereafter. The primary endpoint is the number of patients who remain HCV-RNA-negative at day 7 after LTx. If at least one patient remains negative, the study will be determined to be positive. Additionally, the investigators will examine the viral kinetics of HCV, tolerability and safety of NTZ.

Detailed description: Recurrence of Hepatitis C virus infection (HCV) is universal after orthotopic liver transplantation (LTx) and is associated with allograft failure, death and need for re-transplantation. Currently, there are no effective therapies to prevent HCV recurrence. Nitazoxanide (NTZ), an oral thiazolide anti-infectious agent, was safe, well tolerated and effective in achieving sustained viral response in patients with chronic HCV genotype 4. Its role in the prevention of HCV recurrence after liver transplantation has not been studied. We propose to conduct an open label pilot study examining the role of NTZ in the prevention of HCV re-infection in eight patients undergoing LTx. First time transplant recipients for chronic HCV without history of renal failure or HIV/HBV co-infection, will receive NTZ immediately prior to LTx and for 3 days thereafter. The primary endpoint is the number of patients who remain HCV-RNA-negative at day 7 after LTx. If at least one patient remains negative, the study will be determined to be positive. Additionally, we will examine the viral kinetics of HCV, tolerability and safety of NTZ.

Eligibility criteria: Inclusion Criteria:

* Adult male or female patients age 18-75
* HCV infection identified by positive, quantifiable HCV RNA prior to transplant

Exclusion Criteria:

* Scheduled recipient of living donor transplantation
* History of chronic hepatitis B or HIV infection
* Transplantation for fulminant hepatic failure
* Estimated glomerular filtration rate \<60ml/min
* Women who are pregnant or breast feeding and men or women that are sexually active but do not agree to use acceptable birth control

Primary outcomes:
measure: undetectable HCV RNA by real-time reverse transcription PCR on day 7 after transplantation.
timeFrame: at day 7
Secondary outcomes:
measure: Viral Kinetics
timeFrame: 4 months
measure: Safety
timeFrame: 7 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic College of Medicine
state: Minnesota
Study officials:
affiliation: Mayo Clinic College of Medicine
name: W Ray Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: