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Transplanting Hepatitis C Positive Thoracic Organs

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ClinicalTrials.gov Identifier: NCT03086044
Recruitment Status : Recruiting
First Posted : March 22, 2017
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Lindsey Baden, MD, Brigham and Women's Hospital

Brief Summary:
This is an open-label, pilot safety and efficacy trial for adults who are active on the heart or lung transplantation lists and are eligible to receive an organ from an increased risk donor who has evidence of active or prior hepatitis C infection (HCV).

Condition or disease Intervention/treatment Phase
Hepatitis C Awaiting Organ Transplant Drug: Sofosbuvir/velpatasvir Other: Monitoring Phase 4

Detailed Description:
This is an open label pilot study transplanting thoracic organs from Hepatitis C positive donors into HCV uninfected recipients at Brigham and Women's Hospital. Heart and lung transplant participants will be stratified into two different study arms depending on whether the donor of the thoracic organ was HCV nucleic acid amplifications technology (NAT) positive or negative. In the NAT positive arm, the recipients will receive a course of direct acting antivirals (DAA) to begin on the day of transplant, or at the earliest time point post-transplant. If the donor was HCV antibody (Ab) positive and NAT negative, the recipients will receive close monitoring with serial HCV viral loads (VL) and will only begin treatment with DAA if they develop HCV viremia.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transplanting Thoracic Organs From Hepatitis C Positive Donors to Hepatitis C Uninfected Recipients
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arm Intervention/treatment
Experimental: HCV NAT Positive Donor

Intervention: 4 week treatment course with a direct acting antiviral, sofosbuvir 400mg / velpatasvir 100mg daily

Participants who receive either heart or lung allografts from a donor who is HCV NAT positive will receive treatment with a direct acting antiviral, sofosbuvir 400mg / velpatasvir 100mg daily, beginning on the day of transplant or as soon as the recipient is able to tolerate oral medications after transplantation.

Drug: Sofosbuvir/velpatasvir
4 weeks of treatment beginning on the day of transplant or as soon as the recipient is able to tolerate oral medications after transplantation.
Other Name: Epclusa

Experimental: HCV NAT Negative, HCV Ab Positive Donor

Intervention: HCV viral load monitoring

Participants who receive either heart or lung allografts from a donor who is HCV Ab positive and NAT negative will have close serial HCV viral load monitoring and will be treated with a direct acting antiviral, 400mg / velpatasvir 100mg daily, for 6 weeks if HCV viremia develops.

Drug: Sofosbuvir/velpatasvir
4 weeks of treatment beginning on the day of transplant or as soon as the recipient is able to tolerate oral medications after transplantation.
Other Name: Epclusa

Other: Monitoring
Close HCV viral load monitoring Will receive direct acting antiviral treatment with 6 weeks of sofosbuvir/velpatasvir if the recipient develops HCV viremia during the post-transplant HCV viral load testing
Other Name: Sofosbuvir/velpatasvir (Epclusa)




Primary Outcome Measures :
  1. Graft survival [ Time Frame: 6 months post-transplant ]
    Functioning cardiac or lung allograft not requiring mechanical support

  2. HCV status of the transplant recipient [ Time Frame: 6 months post-transplant ]
    Sustained virologic response (SVR) 12 weeks after HCV treatment completion in Arm A or at 6 months in Arm B (SVR defined as HCV RNA < lower limit of quantification)


Secondary Outcome Measures :
  1. Treatment related adverse events [ Time Frame: 6 months post-transplant ]
    Number of treatment related adverse events per patient using direct-acting antiviral HCV regimens in post lung and cardiac transplant recipients



Information from the National Library of Medicine

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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

Inclusion Criteria:

  • Men and women who are age ≥ 18 years
  • Active on either the cardiac or lung transplant waiting list
  • Willing and able to provide written informed consent to receive organs from an increased risk donor with a known transmissible infection

Exclusion Criteria:

  • HIV antibody or HIV NAT positive
  • Hepatitis B surface antigen or Hepatitis B NAT or viral load positive
  • Evidence of cirrhosis or clinically significant liver disease

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): NCT03086044


Contacts
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Contact: Ann Woolley, MD 617-732-5500 awoolley@bwh.harvard.edu

Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Ann Woolley, MD    617-525-8418    awoolley@partners.org   
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Principal Investigator: Lindsey Baden, MD Brigham and Women's Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lindsey Baden, MD, Associate Professor at Harvard Medical School, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03086044     History of Changes
Other Study ID Numbers: 2016-P001170
First Posted: March 22, 2017    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
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.: No

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