- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01603108
Rifaximin to Prevent Recurrent HCV-Related Fibrosis After Liver Transplant (Rifaximin)
Prospective Randomized Double Blind Placebo Controlled Trial of Rifaximin 550mg PO Twice Daily for Three Months to Prevent Recurrent Fibrosis in Liver Transplant Recipients With Chronic Hepatitis C Virus Infection
The purpose of this study is to determine if the administration of a poorly-absorbable antibiotic (rifaximin) for the first three months after liver transplant will reduce the amount of fibrosis (or scarring of the liver) in liver transplant patients with recurrent hepatitis C virus (HCV) by lowering serum lipopolysaccharide (LPS), a protein in blood that comes from the bacteria in intestines and may cause scarring in the liver.
Approximately 60 subjects will participate in this study. Subjects will be part of the study for approximately 1 year post transplant.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
New York
-
New York, New York, Förenta staterna, 10032
- Columbia University Medical Center - NYPH
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Subject must provide written informed consent before any study assessment is performed
- Age ≥ 18 years
- Willing and able to sign informed consent
- Chronic HCV infection with viremia
- Listed for liver transplantation
- Demonstrate ability to take oral medications prior to randomization (post LT)
Exclusion Criteria:
- Age < 18 years old
- Unwilling/able to sign informed consent
- Cleared HCV infection (and therefore not at risk for recurrent HCV)
- Human immunodeficiency virus (HIV) co-infection
- Hepatitis B (HBV) co-infection
- Participation in another interventional clinical trial
- Females of childbearing (reproductive) potential must have a negative serum pregnancy test at Screening and agree to use an acceptable method of contraception throughout their participation in the study
- Subjects with history of hypersensitivity to rifaximin, rifampin, rifamycin antimicrobial agents, or any of the components of rifaximin
- Subjects with history of tuberculosis infection or has received treatment for tuberculosis infection. If subject has previous positive test for tuberculosis antigen then they must have current negative chest x-ray to be eligible
- Subject has diarrhea and positive Clostridium difficile (C. difficile) toxin via stool examination during Screening period. NOTE: Stool examination for C. difficile toxin will be performed on subjects who have diarrhea during the screening period. Results of stool tests should be confirmed as negative prior to randomization
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Rifaximin Arm
Rifaximin will be initiated post-LT, once the subject is able to tolerate oral medications/diet.
Rifaximin will be dosed at 550mg twice daily for 90 days (+/- 10 days) post-LT.
|
Rifaximin will be initiated post-LT, once the subject is able to tolerate oral medications/diet.
Rifaximin will be dosed at 550mg twice daily for 90 days (+/- 10 days) post-LT.
Andra namn:
|
Placebo-jämförare: Placebo Control Arm
Rifaximin placebo will be initiated post-LT, once the subject is able to tolerate oral medications/diet.
Rifaximin placebo will be taken twice daily for 90 days (+/- 10 days) post-LT.
|
Rifaximin placebo will be initiated post LT, once the subject is able to tolerate oral medications/diet.
Rifaximin placebo dosed at 550 mg twice daily for 90 days (+/10 days) post LT.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Significant recurrence of Hepatitis C
Tidsram: One year post liver transplant
|
Significant recurrence of hepatitis C at one year post-LT defined as at least stage 2 fibrosis, fibrosing cholestatic hepatitis or death/graft failure due to HCV.
|
One year post liver transplant
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Measurement of Serum LPS
Tidsram: 3 months and 12 months post liver transplant
|
Comparison of serum LPS measurements between groups, to determine if the use of rifaximin is associated with reduction in serum LPS.
|
3 months and 12 months post liver transplant
|
Measurement of mRNA markers of the fibrosis cascade
Tidsram: 3 months and 12 months post liver transplant
|
Comparison of mRNA markers of the fibrosis cascade between groups in the 3 month and 1 year post-LT liver biopsies.
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3 months and 12 months post liver transplant
|
Number of adverse events (severe and non-serious)
Tidsram: Up to 30 days post study participation
|
Evaluation of the safety of Rifaximin compared to placebo in early post liver transplant patients, by assessing adverse events and severe adverse events experienced by the patients during the Rifaximin treatment course.
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Up to 30 days post study participation
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Elizabeth Verna, MD, Columbia University
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Patologiska processer
- RNA-virusinfektioner
- Virussjukdomar
- Infektioner
- Blodburna infektioner
- Smittsamma sjukdomar
- Leversjukdomar
- Flaviviridae-infektioner
- Hepatit, Viral, Human
- Fibros
- Hepatit
- Hepatit C
- Anti-infektionsmedel
- Gastrointestinala medel
- Antibakteriella medel
- Rifaximin
Andra studie-ID-nummer
- AAAI4155
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