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Prevention of De Novo HCV With Antiviral HCV Therapy Post-Liver and Post-Kidney Transplant (PRO-ACT:)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03619837
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatitis C Transplantation Disease Transmission Drug: Sofosbuvir/Velpatasvir Drug: Sofosbuvir/Velpatasvir/Voxilaprevir Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: PRO-ACT: Prevention of De Novo HCV With Antiviral HCV Therapy Post-Liver
Actual Study Start Date : July 15, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arm Intervention/treatment
Experimental: Treatment Arm

Single Arm: Sofosbuvir/Velpatasvir

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

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

Drug: Sofosbuvir/Velpatasvir/Voxilaprevir

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

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





Primary Outcome Measures :
  1. Proportion of participants with HCV RNA level below limits of quantification (LOQ) [ Time Frame: 12 weeks after end of treatment ]

Secondary Outcome Measures :
  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 ]

Other Outcome Measures:
  1. Survival rate of patients and their allografts 6 months post liver transplant [ Time Frame: 6 months from time of liver transplant ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03619837


Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Rae Davis    415-514-3274    rayshawnda.davis@ucsf.edu   
Contact: Wesley Chan    415-476-5504    wesley.chan@ucsf.edu   
Principal Investigator: Norah Terrault, MD         
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Sandra Boimbo    303-724-8892    Sandra.Boimbo@ucdenver.edu   
Principal Investigator: James Burton, MD         
United States, Georgia
Piedmont Research Institute Recruiting
Atlanta, Georgia, United States, 30309
Contact: Natasha Morris    404-605-4618    Natasha.Morris@piedmont.org   
Contact: Bethany.Lane@piedmont.org Lane    404.605.4618    Bethany.Lane@piedmont.org   
Principal Investigator: Raymond Rubin, MD         
United States, New York
Columbia University Not yet recruiting
New York, New York, United States, 10032
Contact: Ashley Rodriguez    212-305-3839    Ar3450@cumc.columbia.edu   
Contact: Lauren Starks    212-305-3839    Lvs2132@cumc.columbia.edu   
Principal Investigator: Elizabeth Verna, MD         
United States, Texas
Baylor University Medical Center - Dallas Not yet recruiting
Dallas, Texas, United States, 75246
Contact: Sharon Primeaux    214-818-7876    Sharon.Primeaux@BSWHealth.org   
Principal Investigator: Joanna Bayer,, MD         
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Susan Dorman, RN    713-441-6316    sadorman@houstonmethodist.org   
Contact: Darrel Cleere, RN       dwcleere@houstonmethodist.org   
Principal Investigator: David Victor, MD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Norah Terrault, MD University of California, San Francisco

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03619837     History of Changes
Other Study ID Numbers: 18-24323
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.: Yes

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