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Protocol transitioned to standard of care, no funding available to continue support of research work or data analysis
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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.
Patients will be selected based on diminished likelihood of receiving a liver from the waitlist within a period during which they would be likely to succumb to severe comorbidities. This will be determined in part through use of a patient's Model of End Stage Liver Disease (MELD) score, listing status, and clinical judgment. To ensure maximal benefit for the recipient, only high quality donor livers will be accepted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with Direct Acting Antiviral (DAA) Fixed Dose Combination | Experimental | 12 weeks of HCV treatment with medically appropriate direct acting antiviral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment with Direct Acting Antiviral tablet | Drug | HCV Treatment for 12 Weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events and Out of Range Lab Values | Safety and tolerability of direct acting antiviral therapy in the liver transplant patient will be monitored by quantifying the number of treatment related adverse events per patient and evaluating clinically significant out of range laboratory results as compared to baseline/pretreatment values per patient. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raymond Chung, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masschusetts General Hospital | Boston | Massachusetts | 02114 | United States |
Coded data is anticipated to be shared with potential collaborators.
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)
Data would only be shared with Institutional Review Board (IRB) approved collaborators.
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Enrolled subjects who did not require treatment with direct acting antivirals were excluded from analysis.
Recruitment occurred between November 2017 and March 2021. 33 subjects underwent liver transplant from an Hepatitis C Virus (HCV) Antibody (Ab) positive donor. 9 subjects received HCV Ab positive/HCV Ribonucleic acid (RNA) (Nucleic Acid Testing (NAT)-) donors and did not receive Direct Acting Antiviral (DAA) treatment. 24 subjects initiated treatment with DAAs.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment With Direct Acting Antiviral Fixed Dose Combination | 12 weeks of HCV treatment with medically appropriate direct acting antiviral Treatment with Direct Acting Antiviral tablet: HCV Treatment for 12 Weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline Analysis population is number of consented subjects initiating Direct Antiviral Treatment
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment With Direct Acting Antiviral Fixed Dose Combination | 12 weeks of HCV treatment with medically appropriate direct acting antiviral Treatment with Direct Acting Antiviral tablet: HCV Treatment for 12 Weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 1 subject died and was not included in analysis | Posted | Count of Participants | Participants | 12 weeks post treatment |
|
|
Adverse events were collect from time of Direct Acting Antiviral Treatment initiation through last dose of therapy, an average of 12 weeks.
Only treatment emergent adverse events were collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment With Direct Acting Antiviral Fixed Dose Combination | 12 weeks of HCV treatment with medically appropriate direct acting antiviral Treatment with Direct Acting Antiviral tablet: HCV Treatment for 12 Weeks |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Raymond Chung, MD | Massachusetts General Hospital | 617-724-7562 | chung.raymond@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 28, 2020 | May 11, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D058625 | End Stage Liver Disease |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| 12 weeks |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Recipient Negative HCV status at time of transplant | Count of Participants | Participants |
|
|
|
| Secondary | Number of Participants With Treatment Emergent Adverse Events and Out of Range Lab Values | Safety and tolerability of direct acting antiviral therapy in the liver transplant patient will be monitored by quantifying the number of treatment related adverse events per patient and evaluating clinically significant out of range laboratory results as compared to baseline/pretreatment values per patient. | Number of participants receiving at least 1 dose of DAA treatment were included in the analysis | Posted | Count of Participants | Participants | 12 weeks |
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|
|
| 2 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
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| D000086982 |
| Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |