Liver TransplantationPhase 1/2FEC-THNCT01824368
Extracorporeal Photopheresis in Liver Transplantation. Phase II Clinical Trial in Safety and Efficacy in Patients With Gradual Decrease of Immunosuppression.
A Phase 1/2 study testing Extracorporeal Photopheresis Procedure (FEC) in people with Liver Transplantation and Immunosuppression, run by Red de Terapia Celular at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate the safety of extracorporeal photopheresis in patients with long-standing liver transplantation subjected to a progressive reduction of immunosuppression by complications arising from its use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation, Immunosuppression
- What is being tested?
- Extracorporeal Photopheresis Procedure (FEC)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2013to Apr 2016
- Phase
- Phase 1/2
- 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
- Have been receiving liver transplant two years ago.
- Be 18 years or older.
- Treatment with immunosuppression including cyclosporine or tacrolimus.
- Having a normal liver function in the last year
- Not have suffered acute rejection in the last year and have no chronic rejection
- Submit any significant side effects from medication immunosuppressive (hypertension, creatinine greater than 1.7 mgDl, diabetes, morbid obesity, osteoporosis, hyperlipidemia, severe hirsutism, neurotoxicity novo malignancy, etc.)
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- Etiology of underlying disease: alcoholic cirrhosis with or without hepatocarcinoma, metabolic diseases, amyloidotic polyneuropathy family, biliary atresia, fulminant hepatitis non-A, non-B, non-C, cirrhosis cryptogenic and generally causes no viral or autoimmune.
- Patients offering sufficient guarantees of adherence to protocol
- Patients who give written informed consent for participate in the study.
- It is necessary that the patient meets all inclusion criteria.
Who cannot join
- Underlying disease of the autoimmune (primary sclerosing cholangitis, autoimmune cirrhosis, primary biliary cirrhosis) or epatocarcinoma about cirrhosis of viral or autoimmune.
- Patients with chronic rejection, or acute rejection in the last year.
- Patients with liver retransplantation.
- patients with history of hypersensitivity or idiosyncratic reactions to methoxsalen, psoralen the compounds or any of the excipients.
- patients with melanoma, cutaneous basal cell carcinoma or squamous cell coexistent.
- Patients with aphakia.
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- Patients taking Oxoralen.
- Pregnant women or nursing mothers, or adults of childbearing age not using effective contraception.
- Participation in another clinical trial.
- Inability to understand informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: FOTOAFERESIS EXTRACORPÓREA EN EL TRASPLANTE HEPÁTICO. ENSAYO CLINICO EN FASE II DE SEGURIDAD Y EFICACIA EN PACIENTES CON RETIRADA PROGRESIVA DE LA INMUNOSUPRESIÓN
The purpose of this study is to evaluate the safety of extracorporeal photopheresis in patients with long-standing liver transplantation subjected to a progressive reduction of immunosuppression by complications arising from its use.
- Conditions
- Liver Transplantation, Immunosuppression
- Being tested
- Extracorporeal Photopheresis Procedure (FEC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Photopheresis Procedure (FEC)Procedure or surgery
The FEC will be held in the Cellex (Therakos), and authorized device in routine use in our unit for performing FEC in the treatment of graft-versus-host and cutaneous T-cell lymphoma. After performing a blood count, will connect the patient to Cellex through a central or peripheral.
1500 mL typically be processed peripheral blood mononuclear fraction obtained by apheresis process. Then be added Uvadex (8-metoxipsolareno, 0.017 mL / mL) to the mononuclear fraction bag and proceed to photoactivation with UVA radiation.
Finally the photoactivated product is again infuse the patient. It will monitor the final blood count to assess hemoglobin and platelets. The entire procedure is performed in a single step and closed mode, with Cellex.
| Study group | Role | What they receive |
|---|---|---|
| People with liver transplantation | Experimental | People with liver transplantation over 2 years following treatment with immunosuppression including cyclosporine or tacrolimus. Receives: Procedure: Extracorporeal Photopheresis Procedure (FEC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse event rate and rate of transplant rejection
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Red de Terapia Celular
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Spanish National Health System, Universidad de Murcia, Hospital Universitario Virgen de la Arrixaca, Public Health Service, Murcia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824368
- Sponsor's protocol ID
- FEC-TH
- Other IDs
- 2012-000633-39
- Acronym
- FEC-TH
- Status last verified
- Apr 2016
- First submitted
- 1 Apr 2013
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FOTOAFERESIS EXTRACORPÓREA EN EL TRASPLANTE HEPÁTICO. ENSAYO CLINICO EN FASE II DE SEGURIDAD Y EFICACIA EN PACIENTES CON RETIRADA PROGRESIVA DE LA INMUNOSUPRESIÓN
- ClinicalTrials.gov ID
- NCT01824368
- Acronym / sponsor ID
- FEC-TH / FEC-TH
- Conditions
- Liver Transplantation, Immunosuppression
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Red de Terapia CelularIndustry (pharma, biotech, devices)
- Collaborators
- Spanish National Health System, Universidad de Murcia, Hospital Universitario Virgen de la Arrixaca, Public Health Service, Murcia
- Study start
- Apr 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 4 Apr 2013 (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.
The purpose of this study is to evaluate the safety of extracorporeal photopheresis in patients with long-standing liver transplantation subjected to a progressive reduction of immunosuppression by complications arising from its use.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People with liver transplantation | Experimental | Procedure: Extracorporeal Photopheresis Procedure (FEC)People with liver transplantation over 2 years following treatment with immunosuppression including cyclosporine or tacrolimus. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Have been receiving liver transplant two years ago.
- Be 18 years or older.
- Treatment with immunosuppression including cyclosporine or tacrolimus.
- Having a normal liver function in the last year
- Not have suffered acute rejection in the last year and have no chronic rejection
Key exclusion criteria (10 listed)
- Underlying disease of the autoimmune (primary sclerosing cholangitis, autoimmune cirrhosis, primary biliary cirrhosis) or epatocarcinoma about cirrhosis of viral or autoimmune.
- Patients with chronic rejection, or acute rejection in the last year.
- Patients with liver retransplantation.
- patients with history of hypersensitivity or idiosyncratic reactions to methoxsalen, psoralen the compounds or any of the excipients.
- patients with melanoma, cutaneous basal cell carcinoma or squamous cell coexistent.
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 |
|---|---|---|
| Extracorporeal Photopheresis Procedure (FEC)The FEC will be held in the Cellex (Therakos), and authorized device in routine use in our unit for performing FEC in the treatment of graft-versus-host and cutaneous T-cell lymphoma. After performing a blood count, will connect the patient to Cellex through a central or peripheral. 1500 mL typically be processed peripheral blood mononuclear fraction obtained by apheresis process. Then be added Uvadex (8-metoxipsolareno, 0.017 mL / mL) to the mononuclear fraction bag and proceed to photoactivation with UVA radiation. Finally the photoactivated product is again infuse the patient. It will monitor the final blood count to assess hemoglobin and platelets. The entire procedure is performed in a single step and closed mode, with Cellex. | Procedure or surgery | People with liver transplantation |
Primary outcome
adverse event rate and rate of transplant rejection
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
- Fundación para la Formación e Investigación Sanitarias Región de MurciaLink provided by the sponsor.
- Servicio Murciano de SaludLink provided by the sponsor.
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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 Phase 1/2 study testing Extracorporeal Photopheresis Procedure (FEC) in people with Liver Transplantation and Immunosuppression, run by Red de Terapia Celular at 1 site in Spain.
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 10 inclusion and 10 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 30 Mar 2017. 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 Spain. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
adverse event rate and rate of transplant rejection (time frame: 1 year). 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 30 Mar 2017.