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Enrollment terminated due to not having any other eligible participants.
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The purpose of this study is to evaluate whether treatment with Epclusa (sofosbuvir/velpatasvir) after lung transplantation in individuals with chronic hepatitis C infection is feasible, safe and effective at curing HCV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epclusa | Other | Epclusa (sofosbuvir 400mg/velpatasvir 100mg) 1 tablet oral or via tube daily for 12 weeks, taken with or without food. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epclusa | Drug | Patients will be treated with this drug for 12 weeks post lung transplant. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Sustained Virologic Response 12 Weeks (SVR 12) in Those Treated With EPCLUSA. | Sustained Virologic Response 12 weeks (SVR 12) in those treated with EPCLUSA. | 12 weeks |
| Number of Patients That Reported an Adverse Event Resulting in Discontinuation of EPCLUSA | Adverse events resulting in discontinuation of EPCLUSA | 1 year |
| Number of Patients Eligible for EPCLUSA Treatment | Eligibility for EPCLUSA treatment within 12 months of lung transplant | within 12 months of lung transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum HCV RNA Levels | Serum HCV RNA levels at 12-, 24-, and 48-weeks after initiation of EPCLUSA | 12, 24, and 48 weeks after initiation of EPCLUSA |
| Number of Participants With Adverse Events Requiring Temporary Interruption of EPCLUSA Therapy |
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Inclusion Criteria:
Exclusion Criteria:
Age <18
Treatment with any of the following agents:
Have any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with subject treatment, assessment or compliance
Hepatitis B surface antigen positive
History of hepatic encephalopathy or variceal hemorrhage
Abnormal hematological and biochemical parameters, including:
Pregnant women or women planning to become pregnant
Women or are breastfeeding
Active or recent history (<=1 year) of drug or alcohol abuse
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| Name | Affiliation | Role |
|---|---|---|
| Omar Mohamedaly, MD | Duke Heath | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Epclusa | Epclusa (sofosbuvir 400mg/velpatasvir 100mg) 1 tablet oral or via tube daily for 12 weeks, taken with or without food. Epclusa: Patients will be treated with this drug for 12 weeks post lung transplant. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Epclusa | Epclusa (sofosbuvir 400mg/velpatasvir 100mg) 1 tablet oral or via tube daily for 12 weeks, taken with or without food. Epclusa: Patients will be treated with this drug for 12 weeks post lung transplant. |
| 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 Sustained Virologic Response 12 Weeks (SVR 12) in Those Treated With EPCLUSA. | Sustained Virologic Response 12 weeks (SVR 12) in those treated with EPCLUSA. | Posted | Count of Participants | Participants | 12 weeks |
|
|
11 months
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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 | Epclusa | Epclusa (sofosbuvir 400mg/velpatasvir 100mg) 1 tablet oral or via tube daily for 12 weeks, taken with or without food. Epclusa: Patients will be treated with this drug for 12 weeks post lung transplant. |
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Enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Omar Mohamedaly | Duke University Medical Center | 919-684-4589 | omar.mohamedaly@duke.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 | May 10, 2018 | May 22, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 28, 2018 | May 22, 2019 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000611331 | sofosbuvir-velpatasvir drug combination |
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Adverse events requiring temporary interruption in EPCLUSA therapy |
| 1 year |
| Patient Survival | 90-day post transplant patient survival | 90 days post-transplant |
| Patient Survival | 1 year post transplant patient survival | 1 year post-tranplant |
| Patient Survival | 90-day post transplant patient survival in recipients of HCV NAT positive donor organ | 90 days post-transplant |
| Patient Survival | 1 year post transplant patient survival in recipients of HCV NAT positive donor organ | 1 year post-transplant |
| 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 |
|
|
| Primary | Number of Patients That Reported an Adverse Event Resulting in Discontinuation of EPCLUSA | Adverse events resulting in discontinuation of EPCLUSA | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Primary | Number of Patients Eligible for EPCLUSA Treatment | Eligibility for EPCLUSA treatment within 12 months of lung transplant | Posted | Count of Participants | Participants | within 12 months of lung transplant |
|
|
|
| Secondary | Change in Serum HCV RNA Levels | Serum HCV RNA levels at 12-, 24-, and 48-weeks after initiation of EPCLUSA | Posted | Number | IU/mL | 12, 24, and 48 weeks after initiation of EPCLUSA |
|
|
|
| Secondary | Number of Participants With Adverse Events Requiring Temporary Interruption of EPCLUSA Therapy | Adverse events requiring temporary interruption in EPCLUSA therapy | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Patient Survival | 90-day post transplant patient survival | Posted | Count of Participants | Participants | 90 days post-transplant |
|
|
|
| Secondary | Patient Survival | 1 year post transplant patient survival | Posted | Count of Participants | Participants | 1 year post-tranplant |
|
|
|
| Secondary | Patient Survival | 90-day post transplant patient survival in recipients of HCV NAT positive donor organ | Posted | Count of Participants | Participants | 90 days post-transplant |
|
|
|
| Secondary | Patient Survival | 1 year post transplant patient survival in recipients of HCV NAT positive donor organ | Posted | Count of Participants | Participants | 1 year post-transplant |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
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| D006525 |
| Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
|