A Pilot Study to Examine the Role of Nitazoxanide to Prevent Recurrence of Hepatitis C After Transplantation
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|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|
- undetectable HCV RNA by real-time reverse transcription PCR on day 7 after transplantation. [ Time Frame: at day 7 ] [ Designated as safety issue: No ]undetectable HCV RNA by real-time reverse transcription PCR on day 7 after transplantation.
- Viral Kinetics [ Time Frame: 4 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||February 2009|
|Study Completion Date:||January 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Experimental: Nitazoxanide arm
All patients will receive 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01074203
|United States, Minnesota|
|Mayo Clinic College of Medicine|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||W Ray Kim, MD||Mayo Clinic College of Medicine|