Hepatitis CPhase 4PRO-ACT:NCT03619837
Prevention of De Novo HCV With Antiviral HCV Therapy Post-Liver and Post-Kidney Transplant
A Phase 4 study testing Sofosbuvir/Velpatasvir and Sofosbuvir/Velpatasvir/Voxilaprevir in people with Hepatitis C and Transplantation Disease Transmission, run by University of California, San Francisco at 6 sites in United States.
Trial summary
In this study, subjects that do not have Hepatitis C virus (HCV) will be transplanted with livers or kidneys from donors who do have HCV. Medications that are used to treat HCV will be given to the study subjects shortly after transplant to protect them from developing the problems HCV can cause to the liver. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis C, Transplantation Disease Transmission
- What is being tested?
- Sofosbuvir/Velpatasvir and Sofosbuvir/Velpatasvir/Voxilaprevir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 6 sitesUnited States
- Study dates
- 15 Jul 2018to 13 Aug 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult (≥ 18 year-old), wait-listed for primary kidney or liver transplant without a potential suitable living donor or for simultaneous liver kidney transplant;
- HCV non-infected at the time of transplant. Subjects who were previously HCV infected but who have had documented SVR12 are eligible to participate;
- Agree to use two methods of birth control during the study;
- Donor characteristics: serum HCV NAT-positive and negative for hepatitis B surface antigen. For liver transplant: pre-donation liver biopsy with no fibrosis (F0) or minimal fibrosis (F1). For kidney transplant: kidney donor profile index < 85%.
Who cannot join
- Donor and/or recipient HIV infection
- Subject pregnant or nursing
- Donor and/or recipient Hepatitis B surface antigen positive
- Kidney-pancreas transplant
- Single organ liver recipients who received hemodialysis for more than 7 days prior to liver transplantation
- Kidney recipients: on dialysis for > 5 years at time of Screening; subjects sensitized with panel reactive antibody > 80%; for single organ kidney transplant, subjects with advanced liver fibrosis (Knodell stage 3) or cirrhosis
- Individuals being treated with and needing to continue rifabutin, rifampin, carbamazepine, phenytoin, phenobarbital, oxcarbazepine, St. John's wort (Hypericum perforatum), medium- or high-dose rosuvastatin or atorvastatin, or high-dose proton pump inhibitors (See Concomitant Medications).
- Individuals treated with amiodarone within 42 days of organ transplant.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Piedmont Research Institute
Atlanta, Georgia, 30309
University of Colorado Denver
Aurora, Colorado, 80045
Baylor University Medical Center - Dallas
Dallas, Texas, 75246
Houston Methodist Hospital
Houston, Texas, 77030
Columbia University
New York, New York, 10032
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: PRO-ACT: Prevention of De Novo HCV With Antiviral HCV Therapy Post-Liver
In this study, subjects that do not have Hepatitis C virus (HCV) will be transplanted with livers or kidneys from donors who do have HCV. Medications that are used to treat HCV will be given to the study subjects shortly after transplant to protect them from developing the problems HCV can cause to the liver.
- Conditions
- Hepatitis C, Transplantation Disease Transmission
- Being tested
- Sofosbuvir/Velpatasvir, Sofosbuvir/Velpatasvir/Voxilaprevir
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sofosbuvir/VelpatasvirDrug
Sofosbuvir/Velpatasvir starting early post-transplant for total of 12 weeks.
Sofosbuvir/Velpatasvir/VoxilaprevirDrug
Only for patients who fail initial treatment with Sofosbuvir/Velpatasvir.
Dosage: 400mg/100mg/100mg daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Single Arm: Sofosbuvir/Velpatasvir
Dosage: 400mg/100mg. Once daily for 12 weeks. Receives: Drug: Sofosbuvir/Velpatasvir; Drug: Sofosbuvir/Velpatasvir/Voxilaprevir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With HCV RNA Level Below Limits of Quantification (LOQ)
The primary outcome was sustained virologic response, defined as HCV RNA below the lower limit of quantification 12 weeks after treatment completion (SVR12). Secondary outcomes included the proportion of patients with SVR24 defined as HCV RNA < lower limit of quantification 24 weeks after the end of treatment; with viral relapse defined as HCV RNA <LLOQ at end of treatment with subsequent quantifiable HCV RNA; and with on-treatment virologic breakthrough defined as > 1 log increase in viral RNA after treatment week 1.
Safety was measured as the adverse events and serious adverse events attributed by the investigator to HCV infection or antiviral therapy; the proportion of recipients who prematurely discontinued antiviral therapy before the planned end of treatment; and patient and graft survival at 6 months post-transplant.
Measured: 12 weeks after end of treatment
Secondary outcomes (1)
Safety as Measured by the Proportion of Participants Who Prematurely Discontinue Antiviral Therapy Before the Planned End of Treatment
1 of 23 patients prematurely discontinued antiviral therapy due to intercurrent graft-versus-host disease that progressed to multiorgan failure.
Measured: 12 weeks after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start15 Jul 2018
- Primary completion21 Dec 2019
- Study completion13 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claus Niemann, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619837
- Sponsor's protocol ID
- 18-24323
- Acronym
- PRO-ACT:
- Status last verified
- Feb 2021
- First submitted
- 13 Jul 2018
- Last updated
- 3 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRO-ACT: Prevention of De Novo HCV With Antiviral HCV Therapy Post-Liver
- ClinicalTrials.gov ID
- NCT03619837
- Acronym / sponsor ID
- PRO-ACT: / 18-24323
- Conditions
- Hepatitis C, Transplantation Disease Transmission
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 15 Jul 2018 (actual)
- Primary completion
- 21 Dec 2019 (actual)
- Study completion
- 13 Aug 2020 (actual)
- First posted
- 8 Aug 2018 (actual)
- Results
- Posted 3 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, subjects that do not have Hepatitis C virus (HCV) will be transplanted with livers or kidneys from donors who do have HCV. Medications that are used to treat HCV will be given to the study subjects shortly after transplant to protect them from developing the problems HCV can cause to the liver.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: Sofosbuvir/Velpatasvir, Drug: Sofosbuvir/Velpatasvir/VoxilaprevirSingle Arm: Sofosbuvir/Velpatasvir Dosage: 400mg/100mg. Once daily for 12 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Adult (≥ 18 year-old), wait-listed for primary kidney or liver transplant without a potential suitable living donor or for simultaneous liver kidney transplant;
- HCV non-infected at the time of transplant. Subjects who were previously HCV infected but who have had documented SVR12 are eligible to participate;
- Agree to use two methods of birth control during the study;
- Donor characteristics: serum HCV NAT-positive and negative for hepatitis B surface antigen. For liver transplant: pre-donation liver biopsy with no fibrosis (F0) or minimal fibrosis (F1). For kidney transplant: kidney donor profile index < 85%.
Key exclusion criteria (8 listed)
- Donor and/or recipient HIV infection
- Subject pregnant or nursing
- Donor and/or recipient Hepatitis B surface antigen positive
- Kidney-pancreas transplant
- Single organ liver recipients who received hemodialysis for more than 7 days prior to liver transplantation
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 |
|---|---|---|
| Sofosbuvir/VelpatasvirSofosbuvir/Velpatasvir starting early post-transplant for total of 12 weeks. | Drug | Treatment Arm |
| Sofosbuvir/Velpatasvir/VoxilaprevirOnly for patients who fail initial treatment with Sofosbuvir/Velpatasvir. Dosage: 400mg/100mg/100mg daily for 12 weeks. | Drug | Treatment Arm |
Primary outcome
Proportion of Participants With HCV RNA Level Below Limits of Quantification (LOQ)
Time frame: 12 weeks after end of treatment
The primary outcome was sustained virologic response, defined as HCV RNA below the lower limit of quantification 12 weeks after treatment completion (SVR12). Secondary outcomes included the proportion of patients with SVR24 defined as HCV RNA < lower limit of quantification 24 weeks after the end of treatment; with viral relapse defined as HCV RNA <LLOQ at end of treatment with subsequent quantifiable HCV RNA; and with on-treatment virologic breakthrough defined as > 1 log increase in viral RNA after treatment week 1. Safety was measured as the adverse events and serious adverse events attributed by the investigator to HCV infection or antiviral therapy; the proportion of recipients who prematurely discontinued antiviral therapy before the planned end of treatment; and patient and graft survival at 6 months post-transplant.
1 secondary outcome
Safety as Measured by the Proportion of Participants Who Prematurely Discontinue Antiviral Therapy Before the Planned End of Treatment
Time frame: 12 weeks after start of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Claus Niemann, MD principal investigator
University of California, San Francisco
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sofosbuvir/Velpatasvir and Sofosbuvir/Velpatasvir/Voxilaprevir in people with Hepatitis C and Transplantation Disease Transmission, run by University of California, San Francisco at 6 sites 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Participants With HCV RNA Level Below Limits of Quantification (LOQ) (time frame: 12 weeks after end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2021.