Hepatitis CEarly Phase 1NCT03702218
Hepatitis C Positive Donor Into Hepatitis C Negative Recipients
A Early Phase 1 study testing Direct Acting Antivirals in people with Hepatitis C, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
Despite many efforts to increase the size of the donor pool, there is a large and growing disparity between the number of donor kidneys and livers available for transplantation and the number of patients on the transplant waiting list. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Direct Acting Antivirals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 1 Jul 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- RECIPIENT INCLUSION CRITERIA
- Patients undergoing solid organ transplantation, including liver, kidney, and simultaneous liver-kidney who are not chronically infected with HCV
- No evident contraindication for organ transplantation
- HCV RNA negative (can be isolated HCV antibody positive provided the patient will have no history of previously treated HCV)
- Age 18-75 years at the time of transplantation
- Signed Informed Consent Form
Show all 12Show fewer
- No identified living organ donor
- Able to travel to the University of Maryland for routine post-transplant and HCV follow-up visits
- Men and women must agree to use at least one barrier method to prevent any secretion exchange
- No active illicit drug use
- DONOR INCLUSION CRITERIA
- Qualitative HCV nucleic acid test (NAT) positive and/or Hepatitis C antibody positive HCV donors offered to the University of Maryland.
Who cannot join
- RECIPIENT EXCLUSION CRITERIA
- History of prior solid organ transplantation
- HIV infection
- HBV surface antigen or DNA positive. Organs from HCV positive donors who are also Hepatitis B core antibody positive (hepatitis B surface antigen negative) can be used. These patients will however need to undergo prophylaxis for HBV according to their respective organ specific criteria and during treatment for hepatitis C due to the increased risk of reactivation of hepatitis B with DAA therapy
- Waitlisted for a multi-organ transplant (with the exception of simultaneous liver-kidney transplant)
- HCV RNA positive (can be isolated HCV antibody positive provided the patient will have no history of previously treated HCV)
Show all 12Show fewer
- Prior direct-acting antiviral (DAA) treatment for HCV. Patients previously treated with interferon-based regimens may be included.
- DONOR EXCLUSION CRITERIA
- Every donor that is considered unsuitable by the transplant surgeon for any reason.
- Hepatocellular carcinoma
- HIV infection
- Use of HCV positive livers to be determined according to current existing criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Medical Center
Baltimore, Maryland, 21201
About this study
Official title: An Open-label Pilot Study to Determine the Safety and Efficacy of Hepatitis C Uninfected Recipients of Renal and Liver Transplants From a Currently Infected or Previously Infected Hepatitis C Donor
Despite many efforts to increase the size of the donor pool, there is a large and growing disparity between the number of donor kidneys and livers available for transplantation and the number of patients on the transplant waiting list. New donor pools are needed to satisfy the lack of available donor organs, along with expanded criteria for the existing donor pools.
A new standard of care now exists at most local and regional transplant centers. This new standard of care is based on the use of multiple direct-acting antiviral agents (DAAs) for treatment of hepatitis C virus (HCV) that have been approved by the Food and Drug Administration (FDA) for the treatment of hepatitis C and are associated with high HCV cure rates and minimal side effect profiles. The efficacy and tolerability of these medications has allowed the expansion of the available donor pool by making HCV antibody positive non viremic organs and HCV-viremic organs (when HCV is detectable in the blood) available to HCV-naive recipients on the organ transplantation waiting list. Expansion of this donor pool may decrease time on the waiting list and improve quality of life and survival while waiting for organ transplantation.
Read more
Study Aim:
We propose a clinical protocol to utilize solid organs from exposed and/or HCV-viremic organ donors for transplantation into HCV negative recipients.
The primary purpose of the clinical protocol is to:
Collect prospective standard of care laboratory data on the results of these interventions
Read the detailed description
Once the donor is accepted for transplantation and the recipient enrolled in the innovative clinical practice, donor HCV Ab status will be requested to initiate HCV RNA viral load testing.
Donor data will be recorded as per our standard practice and as mandated by UNOS. Our University of Maryland Medical Center team will be responsible for the donor operation as per standard of care.
Hep C Ab + NAT - Donor to Naïve Recipient This group will be monitored as illustrated in figure 1. Hep C Ab+ NAT+ Donor to Naïve Recipient HCV RNA levels, liver biochemistries, and renal function will be measured 3 days after transplant. HCV Genotype will be determined after HCV RNA is >1,000 IU/mL. HCV RNA levels will be measured weekly after transplant until HCV treatment is initiated.
Due to risk of HBV reactivation with DAA therapy, Hepatitis B surface antigen, surface antibody and core antibody status will be determined prior to HCV therapy. In patients with a prior exposure to HBV (i.e. positive HBV core antibody), Hepatitis B surface antigen levels will be monitored throughout therapy.
All patients will be seen in the Hepatology clinic within 4 weeks of transplant to establish care and follow-up.
HCV Therapy DAA therapy will be prescribed to all patients according to AASLD and IDSA joint guidelines, after giving consideration to the transplanted organ, renal function, and HCV genotype. All regimens exclude administration of ribavirin.
Therapy will be initiated as soon as possible (pending initiation of oral intake and insurance approval) following organ transplantation.
DAAs will be prescribed, after which medications will then be delivered to the patient's home or to the bedside.
If therapy is delayed beyond the 4-week appointment with Hepatology post-transplant, a protocol to monitor for infection, new-onset diabetes mellitus, glomerulonephritis and severe cholestatic hepatitis will be implemented. This protocol will include weekly blood work to include: CBC with differential, hepatic function panel, basic metabolic panel, and coagulation studies.
Liver Transplant:
- Combinations of choice:
- Mavyret (glecaprevir/pibrentasvir) - Genotype 1-6
- Harvoni (ledipasvir/sofosbuvir) + Ribavirin - Genotypes 1, 4, 5, 6; GFR>30
- Epclusa (sofosbuvir/velpatasvir) + Ribavirin - Genotypes 1-6; GFR>30
Kidney Transplant:
- Combinations of choice:
- Mavyret (glecaprevir/pibrentasvir) - genotype 1-6
- Harvoni (sofosbuvir/ledipasvir) - genotype 1, 4; GFR>30 HCV Follow-Up HCV RNA, complete blood count (CBC) and liver biochemistries will be checked 4 weeks, 8 weeks, and 12 weeks after starting therapy. In patients previously exposed to HBV, HBV surface antigen will be followed qualitatively at the same intervals.
HCV RNA will also be checked 12 weeks after completion of therapy to define cure, or sustained virologic response. As part of long-term follow-up, HCV RNA will be checked annually at routine post-transplant visits.
If SVR is not achieved, a second, and if needed, third antiviral regimen will be provided to the participant at no cost.
Transplant, Post-Operative, Immunosuppression Follow Up All will be as per UMMC standard of care. Unless otherwise contraindicated, tacrolimus immune suppression will be favored, due to drug-drug interactions associated with DATs and cyclosporine.
- Conditions
- Hepatitis C
- Being tested
- Direct Acting Antivirals
- Keywords
- Transplantation, Hepatitis C
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Acting AntiviralsDrug
Patients who are given organ transplants from donors that are Ab positive and NAT negative or Ab positive and NAT positive for Hepatitis C will be treated with direct acting antivirals after transplant if they become NAT+ for hepatitis C.
Interventions as follows.
Liver Transplant:
- Combinations of choice:
- Mavyret (glecaprevir/pibrentasvir) - Genotype 1-6
- Harvoni (ledipasvir/sofosbuvir) + Ribavirin - Genotypes 1, 4, 5, 6; GFR>30
- Epclusa (sofosbuvir/velpatasvir) + Ribavirin - Genotypes 1-6; GFR>30
Kidney Transplant:
- Combinations of choice:
- Mavyret (glecaprevir/pibrentasvir) - genotype 1-6
- Harvoni (sofosbuvir/ledipasvir) - genotype 1, 4; GFR>30
| Study group | Role | What they receive |
|---|---|---|
| Hep C Ab + NAT - Donor to Naïve Recipient | Experimental | HCV Ab and HCV NAT testing at 3 days, week 1, week 2 and monthly for 3 months, at 6 months and 1 year. In approximately 16% of the patients, active hepatis C infection will ensue. For these patients, treatment is as follows.
Liver Transplant:
• Combinations of choice:
* Mavyret (glecaprevir/pibrentasvir) - Genotype 1-6
* Harvoni (ledipasvir/sofosbuvir) + Ribavirin - Genotypes 1, 4, 5, 6; GFR>30
* Epclusa (sofosbuvir/velpatasvir) + Ribavirin - Genotypes 1-6; GFR>30
Kidney Transplant:
• Combinations of choice:
* Mavyret (glecaprevir/pibrentasvir) - genotype 1-6
* Harvoni (sofosbuvir/ledipasvir) - genotype 1, 4; GFR>30 Receives: Drug: Direct Acting Antivirals |
| Hep C Ab+ NAT+ Donor to Naïve Recipient | Experimental | HCV RNA levels, liver biochemistries, and renal function will be measured 3 days after transplant. HCV Genotype will be determined after HCV RNA is >1,000 IU/mL. HCV RNA levels will be measured weekly after transplant until HCV treatment is initiated.
Liver Transplant:
• Combinations of choice:
* Mavyret (glecaprevir/pibrentasvir) - Genotype 1-6
* Harvoni (ledipasvir/sofosbuvir) + Ribavirin - Genotypes 1, 4, 5, 6; GFR>30
* Epclusa (sofosbuvir/velpatasvir) + Ribavirin - Genotypes 1-6; GFR>30
Kidney Transplant:
• Combinations of choice:
* Mavyret (glecaprevir/pibrentasvir) - genotype 1-6
* Harvoni (sofosbuvir/ledipasvir) - genotype 1, 4; GFR>30 Receives: Drug: Direct Acting Antivirals |
| Hep C Ab- NAT - Donor to Naïve Recipient | Active comparator | Current standard of care for donor recipient infectious disease matching. No treatment necessary Receives: Drug: Direct Acting Antivirals |
What is being measured
The primary outcome is the main question the study is designed to answer.
SVR after receiving an organ from a donor previously exposed to Hepatitis C after treatment direct-acting antiviral drugs.
To improve access to transplantation with use of HCV-non viremic and HCV-viremic organs in HCV negative patients
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start1 Jul 2019
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Why it stopped: never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03702218
- Sponsor's protocol ID
- HP-00083009
- Status last verified
- Jul 2019
- First submitted
- 8 Oct 2018
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Results will be published in peer reviewed journals.
Publications
Goldberg DS, Blumberg E, McCauley M, Abt P, Levine M. Improving Organ Utilization to Help Overcome the Tragedies of the Opioid Epidemic. Am J Transplant. 2016 Oct;16(10):2836-2841. doi: 10.1111/ajt.13971. Epub 2016 Aug 24.
PubMed 27438538Bari K, Luckett K, Kaiser T, Diwan T, Cuffy M, Schoech MR, Safdar K, Blackard JT, Apewokin S, Paterno F, Sherman KE, Zucker SD, Anwar N, Shah SA. Hepatitis C transmission from seropositive, nonviremic donors to non-hepatitis C liver transplant recipients. Hepatology. 2018 May;67(5):1673-1682. doi: 10.1002/hep.29704. Epub 2018 Mar 26.
PubMed 29205441
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Pilot Study to Determine the Safety and Efficacy of Hepatitis C Uninfected Recipients of Renal and Liver Transplants From a Currently Infected or Previously Infected Hepatitis C Donor
- ClinicalTrials.gov ID
- NCT03702218
- Acronym / sponsor ID
- HP-00083009
- Conditions
- Hepatitis C
- Keywords
- Transplantation, Hepatitis C
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 11 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite many efforts to increase the size of the donor pool, there is a large and growing disparity between the number of donor kidneys and livers available for transplantation and the number of patients on the transplant waiting list. New donor pools are needed to satisfy the lack of available donor organs, along with expanded criteria for the existing donor pools.
A new standard of care now exists at most local and regional transplant centers. This new standard of care is based on the use of multiple direct-acting antiviral agents (DAAs) for treatment of hepatitis C virus (HCV) that have been approved by the Food and Drug Administration (FDA) for the treatment of hepatitis C and are associated with high HCV cure rates and minimal side effect profiles. The efficacy and tolerability of these medications has allowed the expansion of the available donor pool by making HCV antibody positive non viremic organs and HCV-viremic organs (when HCV is detectable in the blood) available to HCV-naive recipients on the organ transplantation waiting list. Expansion of this donor pool may decrease time on the waiting list and improve quality of life and survival while waiting for organ transplantation.
Study Aim:
We propose a clinical protocol to utilize solid organs from exposed and/or HCV-viremic organ donors for transplantation into HCV negative recipients.
The primary purpose of the clinical protocol is to:
Collect prospective standard of care laboratory data on the results of these interventions
Detailed description
Once the donor is accepted for transplantation and the recipient enrolled in the innovative clinical practice, donor HCV Ab status will be requested to initiate HCV RNA viral load testing.
Donor data will be recorded as per our standard practice and as mandated by UNOS. Our University of Maryland Medical Center team will be responsible for the donor operation as per standard of care.
Hep C Ab + NAT - Donor to Naïve Recipient This group will be monitored as illustrated in figure 1. Hep C Ab+ NAT+ Donor to Naïve Recipient HCV RNA levels, liver biochemistries, and renal function will be measured 3 days after transplant. HCV Genotype will be determined after HCV RNA is >1,000 IU/mL. HCV RNA levels will be measured weekly after transplant until HCV treatment is initiated.
Due to risk of HBV reactivation with DAA therapy, Hepatitis B surface antigen, surface antibody and core antibody status will be determined prior to HCV therapy. In patients with a prior exposure to HBV (i.e. positive HBV core antibody), Hepatitis B surface antigen levels will be monitored throughout therapy.
All patients will be seen in the Hepatology clinic within 4 weeks of transplant to establish care and follow-up.
HCV Therapy DAA therapy will be prescribed to all patients according to AASLD and IDSA joint guidelines, after giving consideration to the transplanted organ, renal function, and HCV genotype. All regimens exclude administration of ribavirin.
Therapy will be initiated as soon as possible (pending initiation of oral intake and insurance approval) following organ transplantation.
DAAs will be prescribed, after which medications will then be delivered to the patient's home or to the bedside.
If therapy is delayed beyond the 4-week appointment with Hepatology post-transplant, a protocol to monitor for infection, new-onset diabetes mellitus, glomerulonephritis and severe cholestatic hepatitis will be implemented. This protocol will include weekly blood work to include: CBC with differential, hepatic function panel, basic metabolic panel, and coagulation studies.
Liver Transplant:
- Combinations of choice:
- Mavyret (glecaprevir/pibrentasvir) - Genotype 1-6
- Harvoni (ledipasvir/sofosbuvir) + Ribavirin - Genotypes 1, 4, 5, 6; GFR>30
- Epclusa (sofosbuvir/velpatasvir) + Ribavirin - Genotypes 1-6; GFR>30
Kidney Transplant:
- Combinations of choice:
- Mavyret (glecaprevir/pibrentasvir) - genotype 1-6
- Harvoni (sofosbuvir/ledipasvir) - genotype 1, 4; GFR>30 HCV Follow-Up HCV RNA, complete blood count (CBC) and liver biochemistries will be checked 4 weeks, 8 weeks, and 12 weeks after starting therapy. In patients previously exposed to HBV, HBV surface antigen will be followed qualitatively at the same intervals.
HCV RNA will also be checked 12 weeks after completion of therapy to define cure, or sustained virologic response. As part of long-term follow-up, HCV RNA will be checked annually at routine post-transplant visits.
If SVR is not achieved, a second, and if needed, third antiviral regimen will be provided to the participant at no cost.
Transplant, Post-Operative, Immunosuppression Follow Up All will be as per UMMC standard of care. Unless otherwise contraindicated, tacrolimus immune suppression will be favored, due to drug-drug interactions associated with DATs and cyclosporine.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hep C Ab + NAT - Donor to Naïve Recipient | Experimental | Drug: Direct Acting AntiviralsHCV Ab and HCV NAT testing at 3 days, week 1, week 2 and monthly for 3 months, at 6 months and 1 year. In approximately 16% of the patients, active hepatis C infection will ensue. For these patients, treatment is as follows. Liver Transplant: • Combinations of choice: * Mavyret (glecaprevir/pibrentasvir) - Genotype 1-6 * Harvoni (ledipasvir/sofosbuvir) + Ribavirin - Genotypes 1, 4, 5, 6; GFR>30 * Epclusa (sofosbuvir/velpatasvir) + Ribavirin - Genotypes 1-6; GFR>30 Kidney Transplant: • Combinations of choice: * Mavyret (glecaprevir/pibrentasvir) - genotype 1-6 * Harvoni (sofosbuvir/ledipasvir) - genotype 1, 4; GFR>30 |
| Hep C Ab+ NAT+ Donor to Naïve Recipient | Experimental | Drug: Direct Acting AntiviralsHCV RNA levels, liver biochemistries, and renal function will be measured 3 days after transplant. HCV Genotype will be determined after HCV RNA is >1,000 IU/mL. HCV RNA levels will be measured weekly after transplant until HCV treatment is initiated. Liver Transplant: • Combinations of choice: * Mavyret (glecaprevir/pibrentasvir) - Genotype 1-6 * Harvoni (ledipasvir/sofosbuvir) + Ribavirin - Genotypes 1, 4, 5, 6; GFR>30 * Epclusa (sofosbuvir/velpatasvir) + Ribavirin - Genotypes 1-6; GFR>30 Kidney Transplant: • Combinations of choice: * Mavyret (glecaprevir/pibrentasvir) - genotype 1-6 * Harvoni (sofosbuvir/ledipasvir) - genotype 1, 4; GFR>30 |
| Hep C Ab- NAT - Donor to Naïve Recipient | Active comparator | Drug: Direct Acting AntiviralsCurrent standard of care for donor recipient infectious disease matching. No treatment necessary |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- RECIPIENT INCLUSION CRITERIA
- DONOR INCLUSION CRITERIA
- Qualitative HCV nucleic acid test (NAT) positive and/or Hepatitis C antibody positive HCV donors offered to the University of Maryland.
Key exclusion criteria (12 listed)
- RECIPIENT EXCLUSION CRITERIA
- History of prior solid organ transplantation
- HIV infection
- HBV surface antigen or DNA positive. Organs from HCV positive donors who are also Hepatitis B core antibody positive (hepatitis B surface antigen negative) can be used. These patients will however need to undergo prophylaxis for HBV according to their respective organ specific criteria and during treatment for hepatitis C due to the increased risk of reactivation of hepatitis B with DAA therapy
- Waitlisted for a multi-organ transplant (with the exception of simultaneous liver-kidney transplant)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct Acting AntiviralsPatients who are given organ transplants from donors that are Ab positive and NAT negative or Ab positive and NAT positive for Hepatitis C will be treated with direct acting antivirals after transplant if they become NAT+ for hepatitis C. Interventions as follows. Liver Transplant: • Combinations of choice: * Mavyret (glecaprevir/pibrentasvir) - Genotype 1-6 * Harvoni (ledipasvir/sofosbuvir) + Ribavirin - Genotypes 1, 4, 5, 6; GFR>30 * Epclusa (sofosbuvir/velpatasvir) + Ribavirin - Genotypes 1-6; GFR>30 Kidney Transplant: • Combinations of choice: * Mavyret (glecaprevir/pibrentasvir) - genotype 1-6 * Harvoni (sofosbuvir/ledipasvir) - genotype 1, 4; GFR>30 | Drug | Hep C Ab + NAT - Donor to Naïve Recipient, Hep C Ab+ NAT+ Donor to Naïve Recipient, Hep C Ab- NAT - Donor to Naïve Recipient |
Primary outcome
SVR after receiving an organ from a donor previously exposed to Hepatitis C after treatment direct-acting antiviral drugs.
Time frame: 12 months
To improve access to transplantation with use of HCV-non viremic and HCV-viremic organs in HCV negative patients
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Background: PubMed 27438538Goldberg DS, Blumberg E, McCauley M, Abt P, Levine M. Improving Organ Utilization to Help Overcome the Tragedies of the Opioid Epidemic. Am J Transplant. 2016 Oct;16(10):2836-2841. doi: 10.1111/ajt.13971. Epub 2016 Aug 24.
- Background: PubMed 29205441Bari K, Luckett K, Kaiser T, Diwan T, Cuffy M, Schoech MR, Safdar K, Blackard JT, Apewokin S, Paterno F, Sherman KE, Zucker SD, Anwar N, Shah SA. Hepatitis C transmission from seropositive, nonviremic donors to non-hepatitis C liver transplant recipients. Hepatology. 2018 May;67(5):1673-1682. doi: 10.1002/hep.29704. Epub 2018 Mar 26.
- Individual participant dataSharing planned: Yes. Results will be published in peer reviewed journals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Direct Acting Antivirals in people with Hepatitis C, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SVR after receiving an organ from a donor previously exposed to Hepatitis C after treatment direct-acting antiviral drugs. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03702218, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023; AzTrials last refreshed its copy on 30 Oct 2026.