Hepatitis CPhase 4NCT02631772
LIVE-C-Free: Early and Late Treatment of Hepatitis C With Sofosbuvir/Ledipasvir in Liver Transplant Recipients
A Phase 4 study testing Sofosbuvir/Ledipasvir x 12 weeks and Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks in people with Hepatitis C, run by Medical University of South Carolina at 4 sites in United States.
Trial summary
The predominant remaining questions for post-transplant treatment of Hepatitis C virus (HCV) in the DAA (direct acting anti-virals) era are whether a ribavirin-free regimen is possible and whether pre-emptive treatment is now a potential option to prevent long-term damage to the allograft. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Sofosbuvir/Ledipasvir x 12 weeks and Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jun 2016to 30 Jun 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age and able to give informed consent
- History of HCV genotype 1 or 4
- Normal EKG
- At least 91 days post orthotopic liver transplant
- Screening laboratory values within defined thresholds
- Detectable HCV RNA at screening
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- Creatinine Clearance of at least 40ml/min using the Cockcroft Gault equation
- Negative pregnancy test for female subjects within 48 hours prior to receiving study medication
- Use of two effective contraception methods if female of childbearing potential or sexually active male unless status post bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or vasectomy
Who cannot join
- Serious or active medical or psychiatric illness
- History of significant or unstable cardiac disease
- Stomach disorder that could interfere with the absorption of the study drug
- Pregnant or nursing females or males with a pregnant female partner
- Co-infected with Hepatits B (HBV) or HIV
- Recipients of an allograft from a donor that was infected with HCV with an unknown genotype or non-genotype 1 or 4 unless the recipient is demonstrated to have only genotype 1 or 4 HCV replication post-transplant
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- Allergic to or intolerant of sofosbuvir, ledipasvir, or ribavirin
- History of exposure to an Nonstructural protein (NS5A) inhibitor
- Within 1 year of transplant AND history of Hepatocellular Carcinoma (HCC) with tumor burden outside of the Milan Criteria (See Appendix II) prior to transplant
- Participated in a clinical study with an investigational drug or biologic within the last 30 days
- Combined liver/kidney transplant
- History of organ transplant other than liver
- Childs Turcotte Pugh (CTP) B or C
- Patients with fibrosing cholestatic hepatitis
- Platelet count of ≤ 30 k/mm3
- Hemoglobin < 10g/dL
- Total bilirubin > 10mg/dL
- Alanine aminotransferase (ALT),aspartate aminotransferase (AST), or alkaline phosphatase ≥ 10x upper limit normal
- Serum sodium < 125mmol/L
- Current use of any of the Prohibited Interventions (Section 5.3.2) and un-willing to discontinue use, or use of amiodarone within 6 months of screening
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, 20057
About this study
The predominant remaining questions for post-transplant treatment of Hepatitis C virus (HCV) in the DAA (direct acting anti-virals) era are whether a ribavirin-free regimen is possible and whether pre-emptive treatment is now a potential option to prevent long-term damage to the allograft.
Our aim is to provide answers to these primary questions with our multicenter, prospective, randomized, open-label intent-to-treat phase IV study
Read the detailed description
This is a multicenter, prospective, randomized, open-label phase IV study.
Compare ledipasvir/sofosbuvir + ribavirin for 12 weeks vs ledipasvir/sofosbuvir alone for 12 weeks in patients over 90 days post-liver transplant
- Conditions
- Hepatitis C
- Being tested
- Sofosbuvir/Ledipasvir x 12 weeks, Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks
- 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/Ledipasvir x 12 weeksDrug
Also called Harvoni
Sofosbuvir/Ledipasvir + Ribavirin x 12 weeksDrug
| Study group | Role | What they receive |
|---|---|---|
| Late Cohort, Arm 1 | Experimental | Ledispasvir (LDV) and Sofosbuvir (SOF) monotherapy x 12 weeks Receives: Drug: Sofosbuvir/Ledipasvir x 12 weeks |
| Late Cohort, Arm 2 | Active comparator | Ledispasvir (LDV) and Sofosbuvir (SOF) +ribavirin x 12 weeks Receives: Drug: Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Efficacy
Treatment efficacy, defined as the percentage of patients achieving sustained virologic response 12 (SVR12) weeks after completing the antiviral regimen
Measured: 12 Weeks
Secondary outcomes (2)
Number of Participants With Virologic Failure
Number of participants who had a nonresponse to treatment or a relapse of disease under study.
Measured: 12 weeks
Hemoglobin Levels
Change in hemoglobin levels over the course of the study
Measured: Week 4, Week 8, Week 12, Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study start1 Jun 2016
- Primary completion30 May 2018
- Study completion30 Jun 2018
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 Medical University of South CarolinaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631772
- Sponsor's protocol ID
- IN-US-337-1830
- Status last verified
- Apr 2019
- First submitted
- 14 Dec 2015
- Last updated
- 7 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LIVE-C-Free: Early and Late Treatment of Hepatitis C With Sofosbuvir/Ledipasvir in Liver Transplant Recipients
- ClinicalTrials.gov ID
- NCT02631772
- Acronym / sponsor ID
- IN-US-337-1830
- Conditions
- Hepatitis C
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 16 Dec 2015 (estimated)
- Results
- Posted 7 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The predominant remaining questions for post-transplant treatment of Hepatitis C virus (HCV) in the DAA (direct acting anti-virals) era are whether a ribavirin-free regimen is possible and whether pre-emptive treatment is now a potential option to prevent long-term damage to the allograft.
Our aim is to provide answers to these primary questions with our multicenter, prospective, randomized, open-label intent-to-treat phase IV study
Detailed description
This is a multicenter, prospective, randomized, open-label phase IV study.
Compare ledipasvir/sofosbuvir + ribavirin for 12 weeks vs ledipasvir/sofosbuvir alone for 12 weeks in patients over 90 days post-liver transplant
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Late Cohort, Arm 1 | Experimental | Drug: Sofosbuvir/Ledipasvir x 12 weeksLedispasvir (LDV) and Sofosbuvir (SOF) monotherapy x 12 weeks |
| Late Cohort, Arm 2 | Active comparator | Drug: Sofosbuvir/Ledipasvir + Ribavirin x 12 weeksLedispasvir (LDV) and Sofosbuvir (SOF) +ribavirin x 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- At least 18 years of age and able to give informed consent
- History of HCV genotype 1 or 4
- Normal EKG
- At least 91 days post orthotopic liver transplant
- Screening laboratory values within defined thresholds
Key exclusion criteria (20 listed)
- Serious or active medical or psychiatric illness
- History of significant or unstable cardiac disease
- Stomach disorder that could interfere with the absorption of the study drug
- Pregnant or nursing females or males with a pregnant female partner
- Co-infected with Hepatits B (HBV) or HIV
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/Ledipasvir x 12 weeksAlso: Harvoni | Drug | Late Cohort, Arm 1 |
| Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks | Drug | Late Cohort, Arm 2 |
Primary outcome
Treatment Efficacy
Time frame: 12 Weeks
Treatment efficacy, defined as the percentage of patients achieving sustained virologic response 12 (SVR12) weeks after completing the antiviral regimen
2 secondary outcomes
Number of Participants With Virologic Failure
Time frame: 12 weeks
Hemoglobin Levels
Time frame: Week 4, Week 8, Week 12, Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
4 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/Ledipasvir x 12 weeks and Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks in people with Hepatitis C, run by Medical University of South Carolina at 4 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 9 inclusion and 20 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 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 7 May 2019). 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?
Treatment Efficacy (time frame: 12 Weeks). 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 7 May 2019.