Cardiac Transplant DisorderPhase 4NCT03026023
Preemptive Zepatier Treatment in Donor HCV Positive to Recipient HCV Negative Cardiac Transplant
A Phase 4 study testing Combindation treatment with Grazoprevir and Elbasvir fixed dose combination tablet, with or without ribavirin in people with Cardiac Transplant Disorder and Hepatitis C, run by Raymond T. Chung, MD at 1 site in United States.
Trial summary
This is a proof of concept, single center study for the donation of HCV-positive hearts to HCV negative recipient patients, with preemptive, interventional treatment with 12-16 weeks of grazoprevir and elbasvir (with or without ribavirin) to prevent HCV transmission upon transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Transplant Disorder, Hepatitis C
- What is being tested?
- Combindation treatment with Grazoprevir and Elbasvir fixed dose combination tablet, with or without ribavirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 30 Jun 2021
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recipient is Age ≥ 18 years
- Serum ALT within normal limits with no history of liver disease
- Lack of sensitization (i.e. PRA < 20%) that would be expected to result in a high likelihood of needing aggressive immunosuppression to treat rejection
Who cannot join
- Sensitization (i.e. PRA >20%)
- Any liver disease in recipient
- Albumin < 3g/dl or platelet count < 75 x 103/mL
- Need for dual organ transplant
Trial locations and contacts
1 site in 1 country.
United States1 site
Masschusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: A Proof of Concept Study for Preemptive Treatment With Grazoprevir and Elbasvir in Donor HCV-positive to Recipient HCV-negative Cardiac Transplant
This is a proof of concept, single center study for the donation of HCV-positive hearts to HCV negative recipient patients, with preemptive, interventional treatment with 12-16 weeks of grazoprevir and elbasvir (with or without ribavirin) to prevent HCV transmission upon transplantation.
Read the detailed description
Phase 1 of this study will be a single case study with only one subject enrolled. Once safety has been demonstrated and HCV infection transmission shown to be prevented by the protocol, the study will expand to 10 additional patients.
Patients will be selected based on their diminished likelihood of receiving a heart 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 listing status (1A, 1B, 2) and clinical judgment, and the Seattle Heart Failure Model.
- Conditions
- Cardiac Transplant Disorder, Hepatitis C
- Being tested
- Combindation treatment with Grazoprevir and Elbasvir fixed dose combination tablet, with or without ribavirin
- Keywords
- Heart Transplant, Cardiac Transplant, Hepatitis C, Zepatier
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combindation treatment with Grazoprevir and Elbasvir fixed dose combination tablet, with or without ribavirinDrug
Also called Zepatier
HCV treatment for 12 to 16 weeks. Treatment length and addition of ribavirin based upon presence of baseline resistance associated variant in the HCV virus. Medications given concurrently.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with grazoprevir + elbasvir +/- ribavirin | Experimental | 12 to 16 weeks of treatment with combination tablet of grazoprevir + elbasvir +/- ribavirin Receives: Drug: Combindation treatment with Grazoprevir and Elbasvir fixed dose combination tablet, with or without ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Undetectable HCV
Negative HCV viral RNA at 12 weeks after the last dose of treatment.
Measured: 12 Weeks post treatment
Secondary outcomes (1)
Safety and tolerability (based on number of adverse events and out of range lab values) of grazoprevir and elbasvir (with or without ribavirin) in patients who have undergone cardiac transplantation
Safety and tolerability of grazoprevir and elbasvir in the cardiac transplant patient will be monitored by quantifying the number of treatment related adverse events per patient and evaluating out of range laboratory results as compared to baseline/pretreatment values per patient.
Measured: Upto 16 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study start1 Aug 2018 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion30 Jun 2021 (estimated)
Why it stopped: moved forward with another protocol utilizing pan genotypic treatment once it became commercially available and FDA approved
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Transplant DisorderStudies 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
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Raymond T. Chung, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor-investigator, Raymond T. Chung, MD, Massachusetts General Hospital
- Investigators
- Raymond T Chung, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03026023
- Sponsor's protocol ID
- 2017P000074
- Status last verified
- Dec 2018
- First submitted
- 13 Jan 2017
- Last updated
- 20 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified patient data will be shared with research collaborators for safety and data analysis.
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept Study for Preemptive Treatment With Grazoprevir and Elbasvir in Donor HCV-positive to Recipient HCV-negative Cardiac Transplant
- ClinicalTrials.gov ID
- NCT03026023
- Acronym / sponsor ID
- 2017P000074
- Conditions
- Cardiac Transplant Disorder, Hepatitis C
- Keywords
- Heart Transplant, Cardiac Transplant, Hepatitis C, Zepatier
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: moved forward with another protocol utilizing pan genotypic treatment once it became commercially available and FDA approved
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Raymond T. Chung, MDUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 1 Aug 2018 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 20 Jan 2017 (estimated)
- 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.
This is a proof of concept, single center study for the donation of HCV-positive hearts to HCV negative recipient patients, with preemptive, interventional treatment with 12-16 weeks of grazoprevir and elbasvir (with or without ribavirin) to prevent HCV transmission upon transplantation.
Detailed description
Phase 1 of this study will be a single case study with only one subject enrolled. Once safety has been demonstrated and HCV infection transmission shown to be prevented by the protocol, the study will expand to 10 additional patients.
Patients will be selected based on their diminished likelihood of receiving a heart 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 listing status (1A, 1B, 2) and clinical judgment, and the Seattle Heart Failure Model.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with grazoprevir + elbasvir +/- ribavirin | Experimental | Drug: Combindation treatment with Grazoprevir and Elbasvir fixed dose combination tablet, with or without ribavirin12 to 16 weeks of treatment with combination tablet of grazoprevir + elbasvir +/- ribavirin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Recipient is Age ≥ 18 years
- Serum ALT within normal limits with no history of liver disease
- Lack of sensitization (i.e. PRA < 20%) that would be expected to result in a high likelihood of needing aggressive immunosuppression to treat rejection
Key exclusion criteria (4 listed)
- Sensitization (i.e. PRA >20%)
- Any liver disease in recipient
- Albumin < 3g/dl or platelet count < 75 x 103/mL
- Need for dual organ 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 |
|---|---|---|
| Combindation treatment with Grazoprevir and Elbasvir fixed dose combination tablet, with or without ribavirinAlso: ZepatierHCV treatment for 12 to 16 weeks. Treatment length and addition of ribavirin based upon presence of baseline resistance associated variant in the HCV virus. Medications given concurrently. | Drug | Treatment with grazoprevir + elbasvir +/- ribavirin |
Primary outcome
Undetectable HCV
Time frame: 12 Weeks post treatment
Negative HCV viral RNA at 12 weeks after the last dose of treatment.
1 secondary outcome
Safety and tolerability (based on number of adverse events and out of range lab values) of grazoprevir and elbasvir (with or without ribavirin) in patients who have undergone cardiac transplantation
Time frame: Upto 16 Weeks
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 20 Dec 2018.
- Individual participant dataSharing planned: Yes. Deidentified patient data will be shared with research collaborators for safety and data analysis.
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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.
Raymond T Chung, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Combindation treatment with Grazoprevir and Elbasvir fixed dose combination tablet, with or without ribavirin in people with Cardiac Transplant Disorder and Hepatitis C, run by Raymond T. Chung, MD 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 3 inclusion and 4 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 20 Dec 2018. 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?
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?
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?
Undetectable HCV (time frame: 12 Weeks post 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 20 Dec 2018.