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Completed

NCT Number: NCT03619837

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

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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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Transplantation Disease Transmission Virus Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of California, San Francisco, San Francisco, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

sofosbuvir/velpatasvir

Drug

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

Sofosbuvir/Velpatasvir/Voxilaprevir

Drug

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

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

Primary outcomes

  1. Proportion of Participants With HCV RNA Level Below Limits of Quantification (LOQ)

    Time frame: 12 weeks after end of treatment

    The primary outcome was sustained virologic response, defined as HCV RNA below the lower limit of quantification 12 weeks after treatment completion (SVR12). Secondary outcomes included the proportion of patients with SVR24 defined as HCV RNA < lower limit of quantification 24 weeks after the end of treatment; with viral relapse defined as HCV RNA <LLOQ at end of treatment with subsequent quantifiable HCV RNA; and with on-treatment virologic breakthrough defined as > 1 log increase in viral RNA after treatment week 1.

    Safety was measured as the adverse events and serious adverse events attributed by the investigator to HCV infection or antiviral therapy; the proportion of recipients who prematurely discontinued antiviral therapy before the planned end of treatment; and patient and graft survival at 6 months post-transplant.

Secondary outcomes

  1. Safety as Measured by the Proportion of Participants Who Prematurely Discontinue Antiviral Therapy Before the Planned End of Treatment

    Time frame: 12 weeks after start of treatment

    1 of 23 patients prematurely discontinued antiviral therapy due to intercurrent graft-versus-host disease that progressed to multiorgan failure.

Other outcomes

  1. Survival Rate of Patients and Their Allografts 6 Months Post Transplant

    Time frame: 6 months from time of liver transplant

    Graft and patient survival at 24 weeks after transplant

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

PRO-ACT: Prevention of De Novo HCV With Antiviral HCV Therapy Post-Liver

Acronym: PRO-ACT:

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Aug 8, 2018
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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