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Lack of funding, transitioned to standard of care
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This is a proof of concept, single center study for the donation of HCV-positive lungs to HCV negative recipient patients, with preemptive, interventional treatment with 8 weeks of commercially available DAA therapy to prevent HCV transmission upon transplantation.
The goal of this study is to determine if preoperative dosing and sustained administration of pan-genotypic DAA therapy after lungs transplantation prevents the transmission of hepatitis C virus (HCV) infection from an HCVpositive donor lung to an HCV naïve recipient.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with Direct Acting Antiviral for HCV | Experimental | 8 weeks of treatment with HCV Direct Acting Antiviral tablet (Mavyret or Epclusa) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinically prescribed direct acting antiviral (Mavyret or Epclusa) HCV treatment for 8 weeks | Drug | 8 weeks of direct acting antiviral treatment based on clinical indication (either Mavyret or Epclusa) |
| Measure | Description | Time Frame |
|---|---|---|
| Undetectable Blood HCV RNA Level | Negative HCV RNA by blood testing at 12 weeks after the last dose of treatment. | 12 weeks post last dose of treatment with DAA |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events | Safety and tolerability of DAA therapy in the lung transplant recipient monitored by quantifying the number of treatment related adverese events per patient and evaluation clinically significant out of range lab results as compared to baseline/pretreatment values per patient | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raymond T Chung, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
Anticipate to share coded data with collaborators
Anticipate data would be available to share within 6 months after the final patient completes the study.
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.
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19 subjects received transplant with an HCV Ab positive organ. 3 of the 19 subjects received an HCV Ab positive/HCV RNA negation (NAT negative) transplant and did not irequire DAA therapy per protocol. 16 subjects received HCV Ab positive/HCV RNA positive (NAT positive) transplant and initiated DAA therapy.
Recruitment occurred between February 2019 and December 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment With Direct Acting Antiviral for HCV | 8 weeks of treatment with HCV Direct Acting Antiviral tablet (Mavyret) Clinically prescribed direct acting antiviral (Mavyret) HCV treatment for 8 weeks: 8 weeks of direct acting antiviral treatment based on clinical indication (Mavyret) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Dec 12, 2018 |
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| Tolerability (Based on Number of Adverse Events and Clinically Significant Laboratory Values) | Tolerability of commercially available DAA therapy in the lung transplant patient will be monitored by quantifying the number of treatment related adverse events per patient and evaluating clinically significant laboratory results | 8 weeks |
| COMPLETED |
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| NOT COMPLETED |
|
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Subjects receiving HCV RNA positive lung transplant and initiating treatment with DAA
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment With Direct Acting Antiviral for HCV | 8 weeks of treatment with HCV Direct Acting Antiviral tablet (Mavyret) Clinically prescribed direct acting antiviral (Mavyret) HCV treatment for 8 weeks: 8 weeks of direct acting antiviral treatment based on clinical indication (either Mavyret) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age collected at time of consent. | Count of Participants | 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 | Count of Participants | Participants |
| ||||||||||||||||||||
| Recipient HCV negative status at time of consent | Count of Participants | 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 | Undetectable Blood HCV RNA Level | Negative HCV RNA by blood testing at 12 weeks after the last dose of treatment. | Number of subjects completing full course of treatment | Posted | Count of Participants | Participants | 12 weeks post last dose of treatment with DAA |
|
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| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Adverse Events | Safety and tolerability of DAA therapy in the lung transplant recipient monitored by quantifying the number of treatment related adverese events per patient and evaluation clinically significant out of range lab 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 | 8 weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Tolerability (Based on Number of Adverse Events and Clinically Significant Laboratory Values) | Tolerability of commercially available DAA therapy in the lung transplant patient will be monitored by quantifying the number of treatment related adverse events per patient and evaluating clinically significant laboratory results | Number of participants receiving at least one dose of DAA were included in the analysis | Posted | Count of Participants | Participants | 8 weeks |
|
|
Adverse events were collected from the time of Direct Acting Antiviral Treatment initiation through last dose of therapy (8 week treatment period)
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 for HCV | Eight weeks of treatment with HCV Direct Acting Antiviral tablet (Mavyret or Epclusa) Clinically prescribed direct acting antiviral (Mavyret or Epclusa) HCV treatment for 8 weeks: 8 weeks of direct acting antiviral treatment based on clinical indication (either Mavyret or Epclusa) | 1 | 16 | 0 | 16 | 0 | 16 |
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Study was terminated prior to completion and prior to meeting enrollment goal primarily due to lack of resources (staffing and funding) and transition of HCV-positive to HCV-negative lung transplants to standard of care. Full planned analysis was not completed due to enrollment number, however primary endpoint was assessed for all 16 subjects receiving treatment.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Raymond Chung, MD | Massachusetts General Hospital | 6177247562 | Chung.Raymond@mgh.harvard.edu |
| May 10, 2022 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D006526 | Hepatitis C |
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| 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 |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000654128 | glecaprevir and pibrentasvir |
| C000611331 | sofosbuvir-velpatasvir drug combination |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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