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Trial record 2 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"

Early Treatment With Sofosbuvir (SOF) and Ledipasvir (LDV) to Prevent HCV Recurrence After Liver Transplantation (OLT)

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ClinicalTrials.gov Identifier: NCT02478229
Recruitment Status : Terminated (difficulty recruiting patients)
First Posted : June 23, 2015
Last Update Posted : August 8, 2016
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
The study is a single centre, single arm, open-label, proof of concept study enrolling 20 adult primary liver transplant recipients with genotype 1 HCV infection. Subjects will receive Sofosbuvir (SOF) and Ledipasvir (LDV) starting at time of liver transplantation (OLT) and continues for 12 weeks. Subjects will be receive 24 week post-treatment follow up.

Condition or disease Intervention/treatment Phase
Hepatitis C Viral Infection Drug: Sofosbuvir (SOF) and Ledipasvir (LDV) Phase 3

Detailed Description:
Hepatitis C viral infection (HCV) leading to end-stage liver disease is the leading indication for liver transplant worldwide. HCV recurrence following liver transplantation is universal, associated with 100-fold increase in viremia levels, and runs at an accelerated course, leading to graft cirrhosis in up to 30% of patients within 5 years. Successful eradication of HCV post transplant normalizes the long term survival of HCV positive liver transplant recipients. This study aims to treat HCV infection starting at the time of transplant. The study is a single centre, single arm, open-label,proof of concept study enrolling 20 adult primary liver transplant recipients with genotype 1 HCV infection. Subjects will receive Sofosbuvir (SOF) 400 mg and Ledipasvir (LDV) 90 mg as a fixed dose combination (FDC) tablet starting at time of liver transplantation (OLT) and continues for 12 weeks. Subjects will receive 24 week post-treatment follow up. The study will investigate if the patient has achieved sustained virological response (SVR) 12 weeks after cessation of treatment (SVR12). Furthermore, safety and efficacy of this treatment regimen beginning at the time of transplant will be investigated.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Treatment With Sofosbuvir (SOF) and Ledipasvir (LDV) to Prevent HCV Recurrence After Liver Transplantation (OLT)
Study Start Date : June 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arm Intervention/treatment
Experimental: SOF and LDV
Single arm: All participants will be started on Sofosbuvir (SOF) 400 mg and Ledipasvir (LDV) 90 mg as a fixed dose combination (FDC) tablet p.o. once daily with or without food starting at the time of liver transplantation (OLT), i.e. first doses given immediately prior to OLT, and continuing for 12 weeks.
Drug: Sofosbuvir (SOF) and Ledipasvir (LDV)



Primary Outcome Measures :
  1. Sustained Virological Response (SVR12) [ Time Frame: 12 weeks after cessation of treatment ]
    Defined as HCV RNA in serum below lower limit of quantification (LLOQ)


Secondary Outcome Measures :
  1. Sustained Virological Response (SVR24) [ Time Frame: 24 weeks after cessation of treatment ]
    Defined as HCV RNA in serum below lower limit of quantification (LLOQ)


Other Outcome Measures:
  1. Virological Relapse [ Time Frame: 12 weeks after cessation of treatment or 24 weeks after cessation of treatment (becoming quantifiable again at 12 (relapse 12) or 24 (relapse 24) weeks after cessation of treatment, respectively) ]
    Defined as HCV RNA in serum below lower limit of quantification (LLOQ)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recipient of a first (primary) live or deceased (after brain or cardiac death) donor liver transplant
  • Willing and able to provide written informed consent
  • Male or Female, age 18-70 years old
  • Medical MELD score ≤30 at time of transplant (calculated based on serum bilirubin, creatinine and INR, i.e. not taking exception points into account)
  • Quantifiable HCV RNA at time of listing or transplant evaluation
  • HCV genotype 1a or 1b infection
  • Female patients must have a negative pregnancy test at enrolment

Exclusion Criteria:

  • Liver re-transplantation
  • Recipients of multiple solid organ transplants
  • Estimated GFR <30ml/min at time of transplant
  • Participants transplanted for fulminant hepatic failure
  • Participants co-infected with HBV or HIV
  • Previous treatment with a Sofosbuvir or Ledipasvir containing regimen
  • Participation in an interventional clinical trial within 1 month prior to enrolment
  • Known allergies or hypersensitivity to Sofosbuvir or Ledipasvir
  • Pregnancy and/or lactation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02478229


Locations
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Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2N2
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Eberhard Renner, M.D. University Health Network, Toronto

Publications:

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02478229     History of Changes
Other Study ID Numbers: 15-8883-A
First Posted: June 23, 2015    Key Record Dates
Last Update Posted: August 8, 2016
Last Verified: August 2016
Keywords provided by University Health Network, Toronto:
Liver transplant
Genotype 1 HCV infection
Sofosbuvir (SOF)/ Ledipasvir (LDV)
Sustained virological response (SVR12 )
Additional relevant MeSH terms:
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Virus Diseases
RNA Virus Infections
Ledipasvir
Hepatitis C
Recurrence
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Flaviviridae Infections
Disease Attributes
Pathologic Processes
Sofosbuvir
Antiviral Agents
Anti-Infective Agents