Liver CirrhosisPhase 4NCT00296244
Steroid Free Immunosuppression in Liver Transplantation
A Phase 4 study testing Steroids, Basiliximab and Tacrolimus in people with Liver Cirrhosis and Liver Transplant Disorder, run by Thomas Jefferson University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether steroid-related complications can be avoided by using steroid-free immuno-suppressive drug regimen after liver transplantation. Read more about this study
- Who is it for?
- Ages 18 to 72 years
- Conditions the study is for
- Liver Cirrhosis, Liver Transplant Disorder
- What is being tested?
- Steroids, Basiliximab and Tacrolimus
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Jun 2008
- 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 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients between 18 and 72 years of age
- Male or female patients who are primary cadaveric liver transplant recipients
- Cold ischemia time must be <20 hours
- Females capable of becoming pregnant must have a negative pregnancy test at baseline and are required to practice an approved method of birth control for the duration of the study and for a period of three months following discontinuation of study medication
- Patient has given written informed consent to participate in the study
Who cannot join
- Patients meeting any of the following criteria at baseline will be excluded from study participation
- Patients who have previously received an organ transplant
- Patients who are recipients of a multiple organ transplants
- Women of childbearing potential not using the contraception method(s) specified in this study, as well as women who are breastfeeding
- Known sensitivity to Simulect or class of Simulect
- Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
- Use of any other investigational agent in the last 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
The purpose of this study is to determine whether steroid-related complications can be avoided by using steroid-free immuno-suppressive drug regimen after liver transplantation.
Read the detailed description
Steroids have remained a standard part of post-transplant immunosuppression, both for prevention and treatment of rejection. However, steroids have been shown to cause long-term adverse effects, such as: susceptibility to infection, obesity, hypertension, hyperlipidemia, diabetes, osteopenia, cataracts and growth retardation in children. They have also been implicated in accelerating Hepatitis C virus (HCV) re-infection post-liver transplantation.
Several studies have shown that early steroid reduction or withdrawal could be done safely to alleviate many steroid-related adverse effects after liver transplantation (OLT).
This is a prospective controlled randomized trial on adult patients who will undergo primary OLT at Thomas Jefferson University Hospital (TJUH).
Forty consecutive OLT recipients shall be randomized into two groups.
- Control group- immuno-suppressive drug regimen consisting of basiliximab (Simulect), tacrolimus (Prograf), Mycophenolic acid (Myfortic), and steroids
- Study group- immuno-suppressive drug regimen consisting of basiliximab, tacrolimus, Mycophenolic acid (Myfortic) without steroids
Basiliximab will be given at 20 mg IV bolus intra-operatively and on the 4th day after transplantation. Tacrolimus shall be administered at a dose of 0.15mg/ kg/ day by mouth or through a naso-gastric tube (NGT), starting not earlier than 24 after the transplant but within 48 hrs after reperfusion. The dose shall be adjusted to achieve a trough level of 10-15 ng/ml during the first 30 days after transplantation and lowered to 5-10 ng/ml, thereafter. Patients randomized to the control group shall be administered methylprednisolone (Solumedrol) 1000 mg IV during the anhepatic phase. Methylprednisolone will be continued according to the following taper schedule: 50 mg IV every 6 hrs on day 1; 40 mg IV every 6hrs on day 2; 30 mg IV every 6 hrs on day 3; 20 mg IV every 6 hrs on day 4; 20 mg IV every 12 hrs on day 5; and Prednisone 20 mg by mouth or NGT on day 6. Prednisone shall be tapered slowly starting at 1 month post-OLT and weaned off completely by 6 months post-OLT. Enteric-coated mycophenolic acid or EC-MPA (Myfortic) will be added to the regimen, particularly in patients with renal impairment or neuro-toxicity to minimize the dose and effects of tacrolimus. It will be started at 720 mg P.O. 2x/ day immediately post-transplant and shall be given for a period of 3 months.
Primary end points of this study at 6 months post-transplant include: graft and patient survival rates, and incidence of acute rejection and therapy employed to treat rejection. Secondary end points include: adverse effects of steroids, particularly, diabetes, obesity, hyperlipidemia, and hypertension; incidence and severity of HCV recurrence, and incidence of infectious complications.
Blood samples of HCV recipients shall be collected on day of surgery, 2 weeks, 1 month, 3 months, and 6 months post-OLT as per TJUH Liver Transplant Protocol. Sera shall be stored at -80C and will be used for quantitative HCV RNA levels by quantitative polymerase chain reaction.
Protocol liver biopsy shall be performed at the time of surgery, between 7-21 days post-OLT and at approximately 3 months after transplantation or as clinically indicated by elevated liver function test results.
Acute rejection shall be treated initially by increasing the tacrolimus dose to achieve a level 15-20 ng/ml for 48 hrs. If liver function test results will not show improvement by the 3rd day after increasing tacrolimus dose, a biopsy should be performed. Only biopsy proven rejection shall be treated according to the following protocol. Mild to moderate rejection shall be treated in the study group with methylprednisolone 1 gm IV with tapering doses of steroid as described above. Steroids shall be discontinued after the completion of the taper. In the control group, methylprednisolone 1 gm IV shall be followed by tapering doses and by prednisone 20 mg once daily, which shall be progressively reduced accordingly. The protocol shall also include a repeat biopsy if there is no improvement in the liver function test at the end of steroid taper. Severe rejection or steroid resistant rejection shall be treated with OKT3 at 5mg IV/ day for 5-10 days after pre-medication.
Recipients with HCV recurrence shall be treated according to TJUH Liver Transplant protocol as follows. Abnormal liver function tests should be evaluated by hepatic imaging to exclude anatomic abnormality. If none, liver biopsy will be done. If liver biopsy shows > grade 4 (inflammation more than mild) or > stage 1 (fibrosis), consider antiviral treatment consisting of Peg-Interferon alpha-2a 180mcg subcutaneously weekly for two weeks. If patient tolerates peg-interferon from hematologic and neuro-psychiatric standpoint, continue peg-interferon, and add ribavirin. Refer to protocol for dosing. Total duration of therapy is 48 weeks.
Follow up period for primary analysis will be six (6) months.
- Conditions
- Liver Cirrhosis, Liver Transplant Disorder
- Being tested
- Steroids, Basiliximab, Tacrolimus, Enteric-coated Mycophenolic acid (EC-MPA)
- Keywords
- steroid-free immunosuppression, liver transplantation
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SteroidsDrug
Also called Methylprednisolone (Solumedrol), Prednisone
Patients randomized to Control group shall be administered steroids as methylprednisolone (Solumedrol) 1000 mg IV during the anhepatic phase. Methylprednisolone will be continued according to the following taper schedule: 50 mg IV every 6 hrs on day 1; 40 mg IV every 6hrs on day 2; 30 mg IV every 6 hrs on day 3; 20 mg IV every 6 hrs on day 4; 20 mg IV every 12 hrs on day 5; and Prednisone 20 mg by mouth or Naso-gastric tube (NGT) on day 6. Prednisone shall be tapered slowly starting at 1 month post-OLT and weaned off completely by 6 months post-OLT.
BasiliximabDrug
Also called Simulect
Basiliximab shall be given as induction therapy at 20 mg IV bolus intra-operatively and on the 4th day after transplantation.
TacrolimusDrug
Also called Prograf
Tacrolimus shall be used as the main maintenance immuno-suppressive drug. It will be given at a dose of 0.15mg/ kg/ day by mouth or through a naso-gastric tube (NGT), starting not earlier than 24 after the transplant but within 48 hrs after reperfusion. The dose shall be adjusted to achieve a trough level of 10-15 ng/ml during the first 30 days after transplantation and lowered to 5-10 ng/ml, thereafter.
Enteric-coated Mycophenolic acid (EC-MPA)Drug
Also called Myfortic
This drug may be given in combination with calcineurin inhibitors (tacrolimus) and steroids for maintenance immuno-prophylaxis to prevent rejection. They are particularly useful in recipients with renal dysfunction and neurotoxicity, when there is a need to reduce dose or delay introduction of calcineurin inhibitors. This drug is given at 720 mg PO BID for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Steroid -free immunosuppression | Other | Study group - Basiliximab, Tacrolimus, Enteric-coated Mycophenolic acid (EC-MPA) Receives: Drug: Basiliximab; Drug: Tacrolimus; Drug: Enteric-coated Mycophenolic acid (EC-MPA) |
| Steroid containing immunosuppression | Other | Control group- Basiliximab, Tacrolimus, EC-MPA, steroids Receives: Drug: Steroids; Drug: Basiliximab; Drug: Tacrolimus; Drug: Enteric-coated Mycophenolic acid (EC-MPA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft Survival Rate
Percentage of recipients whose liver grafts are still working at the end of 1 and 2 years.
Measured: 1 and 2 years
Patient Survival Rate
Percentage of recipients who are still alive at the end of 1 and 2 years.
Measured: 1 and 2 years
Acute Rejection Rate
Biopsy proven acute rejection defined by biochemical and histological changes as well as the need for temporary steroid use occurred in 1 patient in each group both of which were steroid responsive
Measured: 6 months post-transplant
Secondary outcomes (3)
Infection as an Adverse Effect of Steroids
Incidence of bacterial infection was similar in the control group as well as study group, 4 patients in both groups had infection
Measured: 3 months post-transplant
Incidence and Severity of HCV Recurrence Post-OLT
The incidence and severity of HCV recurrence based on Hepatitis C PCR levels and protocol liver biopsy findings were found to be similar between the 2 groups.
Measured: 6 months post-transplant
New-onset Diabetes Mellitus (NODM) as Secondary Outcome
The incidence of new-onset Diabetes mellitus (NODM, based on percentage of previously non-diabetic patients who developed DM post-transplantation, was similar between the 2 groups.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2006 (estimated)
- Study startFeb 2006
- Primary completionMay 2008
- Study completionJun 2008
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 Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Carlo Gerardo B Ramirez, M.D., Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00296244
- Sponsor's protocol ID
- CERL080AUS29
- Status last verified
- Oct 2012
- First submitted
- 23 Feb 2006
- Last updated
- 19 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Steroid Free Immunosuppression in Liver Transplantation
- ClinicalTrials.gov ID
- NCT00296244
- Acronym / sponsor ID
- CERL080AUS29
- Conditions
- Liver Cirrhosis, Liver Transplant Disorder
- Keywords
- steroid-free immunosuppression, liver transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Feb 2006
- Primary completion
- May 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 24 Feb 2006 (estimated)
- Results
- Posted 19 Nov 2012
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 determine whether steroid-related complications can be avoided by using steroid-free immuno-suppressive drug regimen after liver transplantation.
Detailed description
Steroids have remained a standard part of post-transplant immunosuppression, both for prevention and treatment of rejection. However, steroids have been shown to cause long-term adverse effects, such as: susceptibility to infection, obesity, hypertension, hyperlipidemia, diabetes, osteopenia, cataracts and growth retardation in children. They have also been implicated in accelerating Hepatitis C virus (HCV) re-infection post-liver transplantation.
Several studies have shown that early steroid reduction or withdrawal could be done safely to alleviate many steroid-related adverse effects after liver transplantation (OLT).
This is a prospective controlled randomized trial on adult patients who will undergo primary OLT at Thomas Jefferson University Hospital (TJUH).
Forty consecutive OLT recipients shall be randomized into two groups.
- Control group- immuno-suppressive drug regimen consisting of basiliximab (Simulect), tacrolimus (Prograf), Mycophenolic acid (Myfortic), and steroids
- Study group- immuno-suppressive drug regimen consisting of basiliximab, tacrolimus, Mycophenolic acid (Myfortic) without steroids
Basiliximab will be given at 20 mg IV bolus intra-operatively and on the 4th day after transplantation. Tacrolimus shall be administered at a dose of 0.15mg/ kg/ day by mouth or through a naso-gastric tube (NGT), starting not earlier than 24 after the transplant but within 48 hrs after reperfusion. The dose shall be adjusted to achieve a trough level of 10-15 ng/ml during the first 30 days after transplantation and lowered to 5-10 ng/ml, thereafter. Patients randomized to the control group shall be administered methylprednisolone (Solumedrol) 1000 mg IV during the anhepatic phase. Methylprednisolone will be continued according to the following taper schedule: 50 mg IV every 6 hrs on day 1; 40 mg IV every 6hrs on day 2; 30 mg IV every 6 hrs on day 3; 20 mg IV every 6 hrs on day 4; 20 mg IV every 12 hrs on day 5; and Prednisone 20 mg by mouth or NGT on day 6. Prednisone shall be tapered slowly starting at 1 month post-OLT and weaned off completely by 6 months post-OLT. Enteric-coated mycophenolic acid or EC-MPA (Myfortic) will be added to the regimen, particularly in patients with renal impairment or neuro-toxicity to minimize the dose and effects of tacrolimus. It will be started at 720 mg P.O. 2x/ day immediately post-transplant and shall be given for a period of 3 months.
Primary end points of this study at 6 months post-transplant include: graft and patient survival rates, and incidence of acute rejection and therapy employed to treat rejection. Secondary end points include: adverse effects of steroids, particularly, diabetes, obesity, hyperlipidemia, and hypertension; incidence and severity of HCV recurrence, and incidence of infectious complications.
Blood samples of HCV recipients shall be collected on day of surgery, 2 weeks, 1 month, 3 months, and 6 months post-OLT as per TJUH Liver Transplant Protocol. Sera shall be stored at -80C and will be used for quantitative HCV RNA levels by quantitative polymerase chain reaction.
Protocol liver biopsy shall be performed at the time of surgery, between 7-21 days post-OLT and at approximately 3 months after transplantation or as clinically indicated by elevated liver function test results.
Acute rejection shall be treated initially by increasing the tacrolimus dose to achieve a level 15-20 ng/ml for 48 hrs. If liver function test results will not show improvement by the 3rd day after increasing tacrolimus dose, a biopsy should be performed. Only biopsy proven rejection shall be treated according to the following protocol. Mild to moderate rejection shall be treated in the study group with methylprednisolone 1 gm IV with tapering doses of steroid as described above. Steroids shall be discontinued after the completion of the taper. In the control group, methylprednisolone 1 gm IV shall be followed by tapering doses and by prednisone 20 mg once daily, which shall be progressively reduced accordingly. The protocol shall also include a repeat biopsy if there is no improvement in the liver function test at the end of steroid taper. Severe rejection or steroid resistant rejection shall be treated with OKT3 at 5mg IV/ day for 5-10 days after pre-medication.
Recipients with HCV recurrence shall be treated according to TJUH Liver Transplant protocol as follows. Abnormal liver function tests should be evaluated by hepatic imaging to exclude anatomic abnormality. If none, liver biopsy will be done. If liver biopsy shows > grade 4 (inflammation more than mild) or > stage 1 (fibrosis), consider antiviral treatment consisting of Peg-Interferon alpha-2a 180mcg subcutaneously weekly for two weeks. If patient tolerates peg-interferon from hematologic and neuro-psychiatric standpoint, continue peg-interferon, and add ribavirin. Refer to protocol for dosing. Total duration of therapy is 48 weeks.
Follow up period for primary analysis will be six (6) months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Steroid -free immunosuppression | Other | Drug: Basiliximab, Drug: Tacrolimus, Drug: Enteric-coated Mycophenolic acid (EC-MPA)Study group - Basiliximab, Tacrolimus, Enteric-coated Mycophenolic acid (EC-MPA) |
| Steroid containing immunosuppression | Other | Drug: Steroids, Drug: Basiliximab, Drug: Tacrolimus, Drug: Enteric-coated Mycophenolic acid (EC-MPA)Control group- Basiliximab, Tacrolimus, EC-MPA, steroids |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female patients between 18 and 72 years of age
- Male or female patients who are primary cadaveric liver transplant recipients
- Cold ischemia time must be <20 hours
- Females capable of becoming pregnant must have a negative pregnancy test at baseline and are required to practice an approved method of birth control for the duration of the study and for a period of three months following discontinuation of study medication
- Patient has given written informed consent to participate in the study
Key exclusion criteria (7 listed)
- Patients meeting any of the following criteria at baseline will be excluded from study participation
- Patients who have previously received an organ transplant
- Patients who are recipients of a multiple organ transplants
- Women of childbearing potential not using the contraception method(s) specified in this study, as well as women who are breastfeeding
- Known sensitivity to Simulect or class of Simulect
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 |
|---|---|---|
| SteroidsAlso: Methylprednisolone (Solumedrol), PrednisonePatients randomized to Control group shall be administered steroids as methylprednisolone (Solumedrol) 1000 mg IV during the anhepatic phase. Methylprednisolone will be continued according to the following taper schedule: 50 mg IV every 6 hrs on day 1; 40 mg IV every 6hrs on day 2; 30 mg IV every 6 hrs on day 3; 20 mg IV every 6 hrs on day 4; 20 mg IV every 12 hrs on day 5; and Prednisone 20 mg by mouth or Naso-gastric tube (NGT) on day 6. Prednisone shall be tapered slowly starting at 1 month post-OLT and weaned off completely by 6 months post-OLT. | Drug | Steroid containing immunosuppression |
| BasiliximabAlso: SimulectBasiliximab shall be given as induction therapy at 20 mg IV bolus intra-operatively and on the 4th day after transplantation. | Drug | Steroid -free immunosuppression, Steroid containing immunosuppression |
| TacrolimusAlso: PrografTacrolimus shall be used as the main maintenance immuno-suppressive drug. It will be given at a dose of 0.15mg/ kg/ day by mouth or through a naso-gastric tube (NGT), starting not earlier than 24 after the transplant but within 48 hrs after reperfusion. The dose shall be adjusted to achieve a trough level of 10-15 ng/ml during the first 30 days after transplantation and lowered to 5-10 ng/ml, thereafter. | Drug | Steroid -free immunosuppression, Steroid containing immunosuppression |
| Enteric-coated Mycophenolic acid (EC-MPA)Also: MyforticThis drug may be given in combination with calcineurin inhibitors (tacrolimus) and steroids for maintenance immuno-prophylaxis to prevent rejection. They are particularly useful in recipients with renal dysfunction and neurotoxicity, when there is a need to reduce dose or delay introduction of calcineurin inhibitors. This drug is given at 720 mg PO BID for 3 months. | Drug | Steroid -free immunosuppression, Steroid containing immunosuppression |
Primary outcome
Graft Survival Rate
Time frame: 1 and 2 years
Percentage of recipients whose liver grafts are still working at the end of 1 and 2 years.
Patient Survival Rate
Time frame: 1 and 2 years
Percentage of recipients who are still alive at the end of 1 and 2 years.
Acute Rejection Rate
Time frame: 6 months post-transplant
Biopsy proven acute rejection defined by biochemical and histological changes as well as the need for temporary steroid use occurred in 1 patient in each group both of which were steroid responsive
3 secondary outcomes
Infection as an Adverse Effect of Steroids
Time frame: 3 months post-transplant
Incidence and Severity of HCV Recurrence Post-OLT
Time frame: 6 months post-transplant
New-onset Diabetes Mellitus (NODM) as Secondary Outcome
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2012.
- 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.
Carlo Gerardo B Ramirez, M.D. principal investigator
Thomas Jefferson University
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 Steroids, Basiliximab and Tacrolimus in people with Liver Cirrhosis and Liver Transplant Disorder, run by Thomas Jefferson University 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 7 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 19 Nov 2012. 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?
Yes. Results are posted in the registry (first posted 19 Nov 2012). 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?
Graft Survival Rate (time frame: 1 and 2 years). The study lists 3 primary outcomes in all. 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 19 Nov 2012.