Hepatitis C InfectionPhase 1NCT01560468
Study of Hepatitis C Virus (HCV) Entry Inhibitor in Liver Transplant Recipients With HCV Infection
A Phase 1 study testing ITX 5061 in people with Hepatitis C Infection, run by Schiano, Thomas D., MD at 1 site in United States.
Trial summary
This study will test the safety and tolerability of HCV Entry Inhibitor ITX 5061 in Liver Transplant Recipients with Hepatitis C infection. The investigators hypothesize that ITX 5061 oral monotherapy will be safe in adults during and after liver transplantation and that therapy will also inhibit HCV infection of… Read more about this study
- Who is it for?
- Ages 18 to 72 years
- Conditions the study is for
- Hepatitis C Infection
- What is being tested?
- ITX 5061
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Apr 2018
- Phase
- 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 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-72
- Patients accepted onto waiting list for liver transplantation for HCV related liver disease and receiving a deceased donor liver allograft
- HCV RNA (+) at time of listing for transplantation. All HCV genotypes will be eligible
- Patients with HCC and those receiving hepatitis B core (+) donor livers will be eligible
- Standard immunosuppression protocol with tacrolimus, corticosteroid taper, and mycophenolate mofetil
Who cannot join
- Viral co-infection (HBV/HIV)
- Receipt of a HCV (+) donor allograft
- Patients undergoing retransplantation for recurrent HCV
- Multivisceral transplantation
- Patients receiving anti-viral therapy at the time of LT
- Live donor liver transplantation
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai School of Medicine
New York, New York, 10029
About this study
Official title: Phase I Study of Hepatitis C Virus (HCV) Entry Inhibitor (ITX 5061) in Liver Transplant Recipients With HCV Infection
This study will test the safety and tolerability of HCV Entry Inhibitor ITX 5061 in Liver Transplant Recipients with Hepatitis C infection. The investigators hypothesize that ITX 5061 oral monotherapy will be safe in adults during and after liver transplantation and that therapy will also inhibit HCV infection of newly transplanted livers in adults with prior HCV infection.
Read the detailed description
All subjects will receive 28 days of ITX 5061 beginning at the time of transplant.
Dosing of ITX 5061 is as follows:
Day of Transplant prior to surgery: ITX 5061 300 mg Day of Transplant following surgery: ITX 5061 300 mg Post-Operative Days 1-6: ITX 5061 300 mg Post-Operative Days 7-27: ITX 5061 150 mg
Subjects will be monitored for HCV RNA levels, HDL cholesterol and ITX 5061 drug concentration levels.
A liver biopsy will be performed at 6 months post-transplant to assess for histological signs of HCV recurrence.
- Conditions
- Hepatitis C Infection
- Being tested
- ITX 5061
- Keywords
- Hepatitis C Virus Infection, Liver Transplantation
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITX 5061Drug
300 mg given orally beginning at the time of liver transplantation and for 1 week post-transplant followed by 150 mg orally for an additional 21 days.
| Study group | Role | What they receive |
|---|---|---|
| ITX 5061 | Experimental | Subjects will receive ITX 5061 for 28 days beginning at the time of liver transplantation for hepatitis C virus. 300mg will be administered on the day of surgery and for one week post transplant, followed by 150mg for an additional 21 days. Receives: Drug: ITX 5061 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of HCV recurrence post-transplant
We hypothesize that ITX 5061 oral monotherapy will be safe in adults during and after liver transplantation and will inhibit HCV infection of newly transplanted livers in adults with prior HCV infection. The number of treated subjects who are infected at 28 days post-transplant will be compared to the historical control rate (95%).
Measured: 28 days
Secondary outcomes (4)
Change in serum HCV RNA
To determine the change in serum HCV RNA from study entry to end of dosing (28 days) and 3 month follow up
Measured: 3 months after transplant
Levels of ITX 5061
To assess trough levels of plasma ITX 5061 throughout the dosing period
Measured: 28 days
Viral dynamics of serum HCV RNA
To characterize the viral dynamics of serum HCV RNA levels during the first 24 hours post-transplant
Measured: 24 hours post-transplant
Potential changes in plasma HCV E2
To characterize potential changes in plasma HCV E2 (HCV envelope protein) regions in the setting of ITX 5061 administration
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionApr 2018
- Study completionApr 2018
Why it stopped: Financial Reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C InfectionStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Schiano, Thomas D., MD
- Sponsor type
- University, hospital or other
- Collaborators
- iTherX Pharmaceuticals Inc.
- Responsible party
- Sponsor
- Investigators
- Thomas D Schiano, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01560468
- Sponsor's protocol ID
- HSM 12-00045
- Other IDs
- 12-0123
- Status last verified
- Apr 2018
- First submitted
- 15 Feb 2012
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sulkowski MS, Kang M, Matining R, Wyles D, Johnson VA, Morse GD, Amorosa V, Bhattacharya D, Coughlin K, Wong-Staal F, Glesby MJ; AIDS Clinical Trials Group A5277 Protocol Team. Safety and antiviral activity of the HCV entry inhibitor ITX5061 in treatment-naive HCV-infected adults: a randomized, double-blind, phase 1b study. J Infect Dis. 2014 Mar 1;209(5):658-67. doi: 10.1093/infdis/jit503. Epub 2013 Sep 16.
PubMed 24041792
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Hepatitis C Virus (HCV) Entry Inhibitor (ITX 5061) in Liver Transplant Recipients With HCV Infection
- ClinicalTrials.gov ID
- NCT01560468
- Acronym / sponsor ID
- HSM 12-00045
- Conditions
- Hepatitis C Infection
- Keywords
- Hepatitis C Virus Infection, Liver Transplantation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Financial Reasons
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Schiano, Thomas D., MDUniversity, hospital or other
- Collaborators
- iTherX Pharmaceuticals Inc.
- Study start
- Mar 2012
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 22 Mar 2012 (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 study will test the safety and tolerability of HCV Entry Inhibitor ITX 5061 in Liver Transplant Recipients with Hepatitis C infection. The investigators hypothesize that ITX 5061 oral monotherapy will be safe in adults during and after liver transplantation and that therapy will also inhibit HCV infection of newly transplanted livers in adults with prior HCV infection.
Detailed description
All subjects will receive 28 days of ITX 5061 beginning at the time of transplant.
Dosing of ITX 5061 is as follows:
Day of Transplant prior to surgery: ITX 5061 300 mg Day of Transplant following surgery: ITX 5061 300 mg Post-Operative Days 1-6: ITX 5061 300 mg Post-Operative Days 7-27: ITX 5061 150 mg
Subjects will be monitored for HCV RNA levels, HDL cholesterol and ITX 5061 drug concentration levels.
A liver biopsy will be performed at 6 months post-transplant to assess for histological signs of HCV recurrence.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ITX 5061 | Experimental | Drug: ITX 5061Subjects will receive ITX 5061 for 28 days beginning at the time of liver transplantation for hepatitis C virus. 300mg will be administered on the day of surgery and for one week post transplant, followed by 150mg for an additional 21 days. |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-72
- Patients accepted onto waiting list for liver transplantation for HCV related liver disease and receiving a deceased donor liver allograft
- HCV RNA (+) at time of listing for transplantation. All HCV genotypes will be eligible
- Patients with HCC and those receiving hepatitis B core (+) donor livers will be eligible
- Standard immunosuppression protocol with tacrolimus, corticosteroid taper, and mycophenolate mofetil
Key exclusion criteria (6 listed)
- Viral co-infection (HBV/HIV)
- Receipt of a HCV (+) donor allograft
- Patients undergoing retransplantation for recurrent HCV
- Multivisceral transplantation
- Patients receiving anti-viral therapy at the time of LT
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 |
|---|---|---|
| ITX 5061300 mg given orally beginning at the time of liver transplantation and for 1 week post-transplant followed by 150 mg orally for an additional 21 days. | Drug | ITX 5061 |
Primary outcome
Incidence of HCV recurrence post-transplant
Time frame: 28 days
We hypothesize that ITX 5061 oral monotherapy will be safe in adults during and after liver transplantation and will inhibit HCV infection of newly transplanted livers in adults with prior HCV infection. The number of treated subjects who are infected at 28 days post-transplant will be compared to the historical control rate (95%).
4 secondary outcomes
Change in serum HCV RNA
Time frame: 3 months after transplant
Levels of ITX 5061
Time frame: 28 days
Viral dynamics of serum HCV RNA
Time frame: 24 hours post-transplant
Potential changes in plasma HCV E2
Time frame: 28 days
Results and safety
The study was stopped early (reason given: Financial Reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Derived from this study: PubMed 24041792Sulkowski MS, Kang M, Matining R, Wyles D, Johnson VA, Morse GD, Amorosa V, Bhattacharya D, Coughlin K, Wong-Staal F, Glesby MJ; AIDS Clinical Trials Group A5277 Protocol Team. Safety and antiviral activity of the HCV entry inhibitor ITX5061 in treatment-naive HCV-infected adults: a randomized, double-blind, phase 1b study. J Infect Dis. 2014 Mar 1;209(5):658-67. doi: 10.1093/infdis/jit503. Epub 2013 Sep 16.
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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.
Thomas D Schiano, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ITX 5061 in people with Hepatitis C Infection, run by Schiano, Thomas D., 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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 18 Apr 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 stopped early (reason given: Financial Reasons). Results are not available in the source record.
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?
Incidence of HCV recurrence post-transplant (time frame: 28 days). 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 NCT01560468, which also lists 1 linked publication.
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 18 Apr 2018.