Prevention of De Novo HCV With Antiviral HCV Therapy Post-Liver and Post-Kidney Transplant

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-15

Study Completion Date

2020-08-13

Brief Summary

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In this study, subjects that do not have Hepatitis C virus (HCV) will be transplanted with livers or kidneys from donors who do have HCV. Medications that are used to treat HCV will be given to the study subjects shortly after transplant to protect them from developing the problems HCV can cause to the liver.

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Detailed Description

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Conditions

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Hepatitis C Transplantation Disease Transmission

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Treatment Arm

Single Arm: Sofosbuvir/Velpatasvir

Dosage: 400mg/100mg. Once daily for 12 weeks.

Group Type EXPERIMENTAL

Sofosbuvir/Velpatasvir

Intervention Type DRUG

Sofosbuvir/Velpatasvir starting early post-transplant for total of 12 weeks.

Sofosbuvir/Velpatasvir/Voxilaprevir

Intervention Type DRUG

Only for patients who fail initial treatment with Sofosbuvir/Velpatasvir.

Dosage: 400mg/100mg/100mg daily for 12 weeks.

Interventions

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Sofosbuvir/Velpatasvir

Sofosbuvir/Velpatasvir starting early post-transplant for total of 12 weeks.

Intervention Type DRUG

Sofosbuvir/Velpatasvir/Voxilaprevir

Only for patients who fail initial treatment with Sofosbuvir/Velpatasvir.

Dosage: 400mg/100mg/100mg daily for 12 weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult (≥ 18 year-old), wait-listed for primary kidney or liver transplant without a potential suitable living donor or for simultaneous liver kidney transplant;
* HCV non-infected at the time of transplant. Subjects who were previously HCV infected but who have had documented SVR12 are eligible to participate;
* Agree to use two methods of birth control during the study;
* Donor characteristics: serum HCV NAT-positive and negative for hepatitis B surface antigen. For liver transplant: pre-donation liver biopsy with no fibrosis (F0) or minimal fibrosis (F1). For kidney transplant: kidney donor profile index \< 85%.

Exclusion Criteria

* Donor and/or recipient HIV infection
* Subject pregnant or nursing
* Donor and/or recipient Hepatitis B surface antigen positive
* Kidney-pancreas transplant
* Single organ liver recipients who received hemodialysis for more than 7 days prior to liver transplantation
* Kidney recipients: on dialysis for \> 5 years at time of Screening; subjects sensitized with panel reactive antibody \> 80%; for single organ kidney transplant, subjects with advanced liver fibrosis (Knodell stage 3) or cirrhosis
* Individuals being treated with and needing to continue rifabutin, rifampin, carbamazepine, phenytoin, phenobarbital, oxcarbazepine, St. John's wort (Hypericum perforatum), medium- or high-dose rosuvastatin or atorvastatin, or high-dose proton pump inhibitors (See Concomitant Medications).
* Individuals treated with amiodarone within 42 days of organ transplant.

Eligible Sex

ALL

Accepts Healthy Volunteers

No