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

NCT03208127 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 2017P000653
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center study for the donation of Hepatitis C Virus (HCV)-positive livers to HCV negative recipient patients, with preemptive, interventional treatment to prevent HCV transmission upon transplantation.

Conditions

End Stage Liver Disease; Hepatitis C

Keywords

HCV; Epclusa; ESLD

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Undetectable Hepatitis C Virus (HCV) Viral RNA

  Number of dosed subjects with negative HCV viral RNA at 12 weeks after the last dose of treatment.

  12 weeks post treatment

Secondary Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events and Out of Range Lab Values

  12 weeks

Study Arms (1)

Treatment with Direct Acting Antiviral (DAA) Fixed Dose Combination

EXPERIMENTAL

12 weeks of HCV treatment with medically appropriate direct acting antiviral

Drug: Treatment with Direct Acting Antiviral tablet

Interventions

Treatment with Direct Acting Antiviral tablet DRUG

HCV Treatment for 12 Weeks

Also known as: DAA

Treatment with Direct Acting Antiviral (DAA) Fixed Dose Combination

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
• Met Massachusetts General Hospital (MGH) transplant center criteria, listed for liver transplant
• HCV naïve
• Able to sign informed consent

You may not qualify if:

• Pregnant or nursing (lactating) women
• Human immunodeficiency virus (HIV) positivity
• Need for dual organ transplant
• Any contra-indication to liver transplantation per center protocol

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Masschusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

End Stage Liver Disease; Hepatitis C

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Protocol transitioned out of research to standard of care and was closed prior to completion and planned enrollment goal was not met. Review of data from enrolled patient was used for reporting purposes and data is primarily descriptive and not based on statistical analysis.

Results Point of Contact

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

chung.raymond@mgh.harvard.edu

617-724-7562

Study Officials

• Raymond 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

Study Record Dates

• First Submitted: July 3, 2017
• First Posted: July 5, 2017
• Study Start: November 21, 2017
• Primary Completion: June 4, 2021
• Study Completion: June 4, 2021
• Last Updated: July 28, 2022
• Results First Posted: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Anticipated that data from the study will become available within 6 months after the final patient completes the primary study endpoint (12 weeks post treatment)
• Access Criteria: Data would only be shared with Institutional Review Board (IRB) approved collaborators.

Locations

US (1)