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Trial record 27 of 1135 for:    IFNA2 AND Antiviral Agents

Effect of Cyclosporine A Versus Tacrolimus on Response to Antiviral Therapy After Hepatitis C Genotype -4 Recurrence Post Liver Transplantation

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ClinicalTrials.gov Identifier: NCT03665766
Recruitment Status : Completed
First Posted : September 11, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Iman Fawzy Montasser, Ain Shams University

Brief Summary:
Background and Aim: The immunosuppression influence on the response to antiviral therapy (AVT) for recurrent hepatitis C virus (HCV) infection in liver transplant (LT) recipients remains controversial, especially for the rarely investigated genotype 4.This study aims to compare the effects of the two widely used calcineurin inhibitors(CNIs)(Cyclosporine A (CsA) and tacrolimus (Tac)) on the therapeutic response to different AVT regimens. Method: In126 living donor liver transplant (LDLT) recipients with recurrent HCV infection, participants were categorized to three groups according to AVT. Group one received pegylated interferon (Peg IFN-α 2a) and ribavirin (RBV) (n= 44), group two received the direct antiviral agent (DAA) sofosbuvir plus RBV (n=52) and group three received daclatasvir, sofosbuvir (other DAAs) plus RBV(n=30) each group was further subdivided according to primary immunosuppression (CsA or Tac). The sustained virological response (SVR) and relapse rates were considered the primary therapeutic outcomes of AVT. The virological response guided therapy end points for AVT were considered the secondary outcomes.

Condition or disease Intervention/treatment
Liver Transplantation Drug: Cycloserine,Tacrolimus

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Study Type : Observational
Actual Enrollment : 126 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Cyclosporine A Versus Tacrolimus on the Response to Antiviral Treatment After HCV Genotype -4 Recurrence in Recipients of Living Donor Liver Transplantation
Actual Study Start Date : May 15, 2014
Actual Primary Completion Date : April 2, 2018
Actual Study Completion Date : April 2, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
IFN group received Cyclosporine
Living donor liver transplantation recipients with recurrent HCV received Peg IFN-α 2a and RBV as antiviral therapy and Cyclosporine A as primary immunosuppression ,this was routinely taken not as intervention according to local practice
Drug: Cycloserine,Tacrolimus
IFN group received tacrolimus
Living donor liver transplantation recipients with recurrent HCV received Peg IFN-α 2a and RBV as antiviral therapy and Tacrolimus as primary immunosuppression ,this was routinely taken not as interventing according to local practice
Drug: Cycloserine,Tacrolimus
Sof plus Rbv group received Cyclosporine
Living donor liver transplantation recipients with recurrent HCV received sofosbuvir and RBV as antiviral therapy and Cyclosporine as primary immunosuppression,this was routinely taken not as intervention according to local practice
Drug: Cycloserine,Tacrolimus
Sof plus Rbv received tacrolimus
Living donor liver transplantation recipients with recurrent HCV received sofosbuvir and RBV as antiviral therapy and Tacrolimus as primary immunosuppression,this was routinely taken not as intervention according to local practice
Drug: Cycloserine,Tacrolimus
Sof,dac pus ribavirin received cyclosporine
Living donor liver transplantation recipients with recurrent HCV received daclatasvir, sofosbuvir and RBV as antiviral therapy and Cyclosporine as primary immunosuppression,this was routinely taken not as intervention according to local practice
Drug: Cycloserine,Tacrolimus
sof,dac plus rbv received tacrolimus
Living donor liver transplantation recipients with recurrent HCV received daclatasvir, sofosbuvir and RBV as antiviral therapy and Tacrolimus as primary immunosuppression,this was routinely taken not as intervention according to local practice
Drug: Cycloserine,Tacrolimus



Primary Outcome Measures :
  1. sustained virological response [ Time Frame: 24 weeks for group I and 12 weeks for group II and III ]
    a negative serum HCV RNA



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
living donor liver transplant (LDLT) recipients with recurrent HCV infection, participants were categorized to three groups according to AVT. Group one received pegylated interferon (Peg IFN-α 2a) and ribavirin (RBV) , group two received the direct antiviral agent (DAA) sofosbuvir plus RBV and group three received daclatasvir, sofosbuvir (other DAAs) plus RBV each group was further subdivided according to primary immunosuppression (CsA or Tac)
Criteria

Inclusion Criteria:group(I):participants received Peg IFN-α 2a and RBV therapy who fulfilled the following inclusion criteria:

  • Age between 18 and 65 years ;
  • elevated aminotransferase levels (ALT and AST)
  • detectable HCV RNA by polymerase chain reaction (PCR)
  • liver biopsy results consistent with HCV recurrence using the Metavir scoring system (Metavir ≥A1F1)
  • For group II and III:
  • age between 18 and 75 years
  • detectable HCV RNA by PCR

Exclusion Criteria:group I

  • if they were younger than 18 years or older than 65 years or had one of the following criteria
  • alcoholic
  • poorly controlled autoimmune disease
  • significant cardiac disease
  • suicidal ideation
  • a history of suicide attempt
  • major psychosis
  • serum creatinine ˃3 mg/dl
  • thyroid dysfunction
  • combined kidney-liver transplantation
  • were currently pregnant or planning pregnancy.

Group II and III:

  • younger than 18 years or older than 75 years
  • total bilirubin (T.Bil) >3 mg/dl
  • serum albumin< 2.8 mg/dl
  • international normalized ratio ≥1.7
  • Platelet count < 5000/mm3
  • HCC, except 4 weeks after intervention with no evidence of activity using computed tomography or magnetic resonance imaging
  • extra hepatic malignancy except after two years of disease free-interval
  • uncontrolled diabetes evidenced by glycated haemoglobin >9%
  • were pregnant .

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Responsible Party: Iman Fawzy Montasser, Associate professor -Tropical medicine-faculty of medicine-Ain Shams University, Ain Shams University
ClinicalTrials.gov Identifier: NCT03665766     History of Changes
Other Study ID Numbers: ASU-1124568
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Additional relevant MeSH terms:
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Antiviral Agents
Immunosuppressive Agents
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Anti-Infective Agents, Urinary
Renal Agents
Antitubercular Agents
Anti-Bacterial Agents
Recurrence
Disease Attributes
Pathologic Processes
Cyclosporine
Cycloserine
Tacrolimus
Cyclosporins
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antitubercular
Antimetabolites