DAA Treatment in Donor HCV-positive to Recipient HCV-negative Heart Transplant

NCT03208244 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 2017P001427
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a proof of concept, single center study for the donation of HCV-positive hearts to HCV negative recipient patients, with preemptive, interventional treatment with 12 weeks of commercially available DAA therapy to prevent HCV transmission upon transplantation.

Conditions

End Stage Heart Disease; Hepatitis C

Keywords

Heart Disease; Heart Transplant; HCV; Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Undetectable HCV RNA at 12 Weeks Post Treatment

  Negative HCV viral RNA at 12 weeks after the last dose of treatment.

  12 weeks post treatment

Secondary Outcomes (1)

• Number of Participants With Adverse Events and Clinically Significant Out of Range Lab Values of DAA Therapy in Patients Undergoing Cardiac Transplantation

  12 weeks

Study Arms (1)

Treatment with Direct Acting Antiviral for HCV

EXPERIMENTAL

12 weeks of treatment with HCV Direct Acting Antiviral tablet

Drug: Clinically prescribed direct acting antiviral

Interventions

Clinically prescribed direct acting antiviral DRUG

HCV treatment for 12 weeks

Also known as: DAA treatment

Treatment with Direct Acting Antiviral for HCV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recipient is Age ≥ 18 years
• Serum ALT within normal limits with no history of liver disease
• Lack of sensitization (i.e. PRA \< 20%) that would be expected to result in a high likelihood of needing aggressive immunosuppression to treat rejection

You may not qualify if:

• Sensitization (i.e. PRA \>20%)
• Any liver disease in recipient
• Albumin \< 3g/dl or platelet count \< 75 x 103/mL
• Need for dual organ transplant

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Masschusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Bethea ED, Gaj K, Gustafson JL, Axtell A, Lebeis T, Schoenike M, Turvey K, Coglianese E, Thomas S, Newton-Cheh C, Ibrahim N, Carlson W, Ho JE, Shah R, Nayor M, Gift T, Shao S, Dugal A, Markmann J, Elias N, Yeh H, Andersson K, Pratt D, Bhan I, Safa K, Fishman J, Kotton C, Myoung P, Villavicencio MA, D'Alessandro D, Chung RT, Lewis GD. Pre-emptive pangenotypic direct acting antiviral therapy in donor HCV-positive to recipient HCV-negative heart transplantation: an open-label study. Lancet Gastroenterol Hepatol. 2019 Oct;4(10):771-780. doi: 10.1016/S2468-1253(19)30240-7. Epub 2019 Jul 26.

  PMID: 31353243 DERIVED

MeSH Terms

Conditions

Hepatitis C; Heart Diseases

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Cardiovascular Diseases

Limitations and Caveats

Protocol was terminated prior to completion, primarily due to lack of resources (research staffing and funding) and clinical team moving HCV+ donor to HCV- recipient transplants to standard of care.

Results Point of Contact

• Title: Raymond Chung, MD
• Organization: Massachusetts General Hospital

Chung.Raymond@mgh.harvard.edu

617-724-7562

Study Officials

• Raymond L Chung, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Hepatology

Model Details: Received heart transplant from HCV+ donor

Study Record Dates

• First Submitted: July 3, 2017
• First Posted: July 5, 2017
• Study Start: November 9, 2017
• Primary Completion: April 20, 2021
• Study Completion: April 28, 2021
• Last Updated: June 22, 2022
• Results First Posted: June 2, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Anticipate data would be available to share within 6 months after the final patient completes the study.
• Access Criteria: Coded data would be shared with collaborators who have received IRB approval to use the data and have been approved by the PI for their collaboration.

Locations

US (1)