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A Pilot Study to Examine the Role of Nitazoxanide to Prevent Recurrence of Hepatitis C After Transplantation

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ClinicalTrials.gov Identifier: NCT01074203
Recruitment Status : Completed
First Posted : February 24, 2010
Last Update Posted : July 31, 2012
Sponsor:
Information provided by:
Mayo Clinic

February 22, 2010
February 24, 2010
July 31, 2012
February 2009
January 2011   (Final data collection date for primary outcome measure)
undetectable HCV RNA by real-time reverse transcription PCR on day 7 after transplantation. [ Time Frame: at day 7 ]
undetectable HCV RNA by real-time reverse transcription PCR on day 7 after transplantation.
Same as current
Complete list of historical versions of study NCT01074203 on ClinicalTrials.gov Archive Site
  • Viral Kinetics [ Time Frame: 4 months ]
    Viral Kinetics: The decline in HCV RNA will be calculated using the HCV RNA levels obtained during the study at the 12 time points.
  • Safety [ Time Frame: 7 days ]
    Safety of NTZ: The safety and tolerability of NTZ will be monitored by evaluating vital signs, change in laboratory data from baseline, adverse events, UPIRSTOs, dose adjustments and incidence of early drug withdrawal. Tolerability will be defined as the number of patients discontinuing medications or having a dose modification due to an adverse event.
Same as current
Not Provided
Not Provided
 
A Pilot Study to Examine the Role of Nitazoxanide to Prevent Recurrence of Hepatitis C After Transplantation
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
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.
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.
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Hepatitis C Recurrence
Drug: Nitazoxanide

Drug administration: The drug will be available through the research pharmacy. Patients will receive 1000mg (2 tablets) oral NTZ or an equivalent dose of NTZ suspension 1500mg (75mL) according to the schedule below.

Dose timing Dose Schedule Interval Dose Pre-transplant(on admission) 1000mg oral Once Total 1 dose Pre-transplant (delayed surgery >12 hours) 1000mg oral Every 12 hrs Variable Post operative dose 1000mg oral/ nasogastric tube Every 12 hrs Total 6 doses

All attempts will be made to administer the tablet form of the medication, given the higher area under the curve that is achieved. If needed, the suspension formulation will be used. Since the suspension form has 70% bioavailability, the suspension dose administered will be 1.5 grams every 12 hours until the tablet form can be given.

Experimental: Nitazoxanide arm
All patients will receive nitazoxanide
Intervention: Drug: Nitazoxanide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
Same as current
January 2011
January 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01074203
08-006000
No
Not Provided
Not Provided
W Ray Kim, Mayo Clinic College of Medicine
Mayo Clinic
Not Provided
Principal Investigator: W Ray Kim, MD Mayo Clinic College of Medicine
Mayo Clinic
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP