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Utilization of Hepatitis C Positive Kidneys in Negative Recipients (USE-Hep C)

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ClinicalTrials.gov Identifier: NCT03801707
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Reem Daloul, Ohio State University

Brief Summary:
To evaluate the safety and feasibility of transplanting kidneys from Hepatitis C virus (HCV) infected donors into recipients without HCV infection

Condition or disease Intervention/treatment Phase
Kidney Transplant Hepatitis C HCV Drug: Sofosbuvir/Velpatasvir Phase 2 Phase 3

Detailed Description:
This will be an open label, prospective, interventional, proof of concept study to evaluate the feasibility and safety of kidney transplant from HCV positive donors into HCV negative recipients using Sofosbuvir/Velpatasvir as a treatment for post-transplant HCV transmission

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Prospective, Interventional, Proof of Concept Study to Evaluate the Feasibility and Safety of Kidney Transplant From HCV Positive Donors Into HCV Negative Recipient Using Sofosbuvir/Velpatasvir as a Treatment for Post-Transplant HCV Transmission
Actual Study Start Date : January 9, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arm Intervention/treatment
Experimental: Sofosbuvir/Velpatasvir (Epclusa) Drug: Sofosbuvir/Velpatasvir
fixed dose combination medication for the treatment of hepatitis C




Primary Outcome Measures :
  1. Proportion of patients with undetectable HCV PCR at 12 weeks after completion of HCV treatment with Sofosbuvir/Velpatasvir [ Time Frame: 12 weeks ]
    Efficacy

  2. The incidence of adverse events related to Sofosbuvir/Velpatasvir drug therapy [ Time Frame: 12 weeks ]
    safety


Secondary Outcome Measures :
  1. eGFR at 6 and 12 months post-transplant [ Time Frame: 6 and 12 months ]
  2. Patient's survival at 6 and 12 months [ Time Frame: 6 and 12 months ]
  3. Graft survival at 12 months [ Time Frame: 12 months ]


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

Recipient Inclusion/Exclusion Criteria:

Inclusion Criteria:

  • Adult age >18 years able to provide consent
  • Lack of available living donor
  • Calculated pre-transplant reactive panel (cPRA) of <80%
  • Estimated post-transplant survival (EPTS) index >20% and <80%
  • Negative pre-transplant HIV, HCV, and HBV serology and blood HCV PCR
  • No clinically significant pre-transplant liver disease
  • Pre-enrollment approval by patient's insurance to cover DAAs therapy
  • Contraception based on the REMS protocol
  • Agree to abstinence form alcohol for at least 6 months post-transplant

Exclusion Criteria:

  • Living donor available Dialysis time >5 years History of previous organ transplantation Listing for multi-organ transplantation Active or recent history (<6 months) of alcohol or substance abuse Clinically significant liver disease as determined by principal investigator History of hepatocarcinoma Pregnancy or lactation Refusal to accept blood transfusion HIV infection HCV pcr or antibody positive HBV infection

Donor Inclusion Criteria:

  • Positive HCV PCR at time of donation
  • KDPI<85%

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): NCT03801707


Contacts
Contact: Reem Daloul, MD 614-293-4665 Reem.Daloul@osumc.edu
Contact: Margaret Wuebker Margaret.Wuebker@osumc.edu

Locations
United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Margaret Wuebker    614-293-4665    Margaret.Wuebker@osumc.edu   
Contact: Corey Newsome       Corey.Newsome@osumc.edu   
Principal Investigator: Reem Daloul         
Sub-Investigator: Todd Pesavento         
Sub-Investigator: Anthony Michaels         
Sub-Investigator: Amer Rajab         
Sub-Investigator: Ashraf El-Hinnawi         
Sub-Investigator: Kenneth Washburn         
Sponsors and Collaborators
Ohio State University

Additional Information:
Publications:

Responsible Party: Reem Daloul, Assistant Professor of Clinical Medicine, Transplant Nephrology, Ohio State University
ClinicalTrials.gov Identifier: NCT03801707     History of Changes
Other Study ID Numbers: 2018H0499
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Sofosbuvir
Sofosbuvir-velpatasvir drug combination
Antiviral Agents
Anti-Infective Agents