Adenovirus InfectionPhase 1NCT01070797
Administration of Rapidly Generated Multivirus-specific Cytotoxic T-Lymphocytes (VIRAGE)
A Phase 1 study testing Multi-virus Specific T cells in people with Adenovirus Infection and Epstein-Barr Virus Infections, run by Baylor College of Medicine at 2 sites in United States.
Trial summary
Patient's on this protocol have a type of blood cell cancer, other blood disease or a genetic disease and have received a stem cell transplant. The donor of the stem cells was either a brother or sister, another relative, or a closely matched unrelated donor. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adenovirus Infection, Epstein-Barr Virus Infections, Cytomegalovirus Infections
- What is being tested?
- Multi-virus Specific T cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2011to Apr 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients will be eligible following any type of allogeneic transplant to receive CTLs as prophylaxis or for early reactivations as defined below.
- Prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using either bone marrow or peripheral blood stem cells.
- Prophylaxis for patients at risk of CMV, adenovirus or EBV infection (for Phase 2 portion only). In the phase 1 portion patients must meet criteria in 3 below.
- Early treatment of reactivation or infection which is defined for each virus as below:
- CMV: CMV antigenemia is monitored at least weekly post transplant. Early reactivation is defined at CMV antigenemia with less than 10 leucocytes positive. If any patient develops CMV antigenemia (with greater than 10 leukocytes positive) or clinical evidence of CMV infection (defined as the demonstration of CMV by biopsy specimen from visceral sites (by culture or histology) either pre or after CTL infusions, standard treatment with Ganciclovir, and/or Foscarnet and Immunoglobulins will be initiated. Patients may receive CTLs for antigenemia or elevated PCR without visceral infection.
- Adenovirus: Adenovirus infection will be defined as the presence of adenoviral positivity as detected by PCR or culture from ONE site such as stool or blood or urine or nasopharynx. Adenovirus disease will be defined as the presence of adenoviral positivity as detected by culture from more than two sites such as stool or blood or urine or nasopharynx. In patients who meet the criteria for disease Cidofovir may be added unless the subject could not tolerate this agent due to nephrotoxicity. Patients may receive CTLs for elevated PCR in blood or stool.
Show all 21Show fewer
- EBV EBV-LPD is defined according to recent guidelines as proven EBV-LPD defined by biopsy or probable EBV-LPD defined as an elevated EBV DNA level associated with clinical symptoms (adenopathy or fever or masses on imaging) but without biopsy confirmation. Patients with EBV DNA reactivation only defined as EBV DNA levels > 1000 copies/ug may also receive CTLs on study. Patients with proven or probable EBV-LPD should also receive Rituxan
- Early treatment may be given to eligible patients with a single or multiple infections. Patients with multiple infections with one reactivation and one controlled infection are eligible to enroll.
- Patient with a CMV seronegative donor may only receive CTLs for a CMV reactivation in the dose escalation phase if the line has activity against CMV.
- Clinical status at enrollment to allow tapering of steroids to less than 0.5 mg/kg/day prednisone.
- Karnofsky/Lansky score of 50 or greater
- ANC greater than 500/µL.
- Bilirubin 2x upper limit normal or less
- AST 3 x normal or less
- Serum creatinine 2 x upper limit normal or less
- HgB >8.0
- Pulse oximetry of > 90% on room air
- Available multi-virus-specific cytotoxic T lymphocytes
- Negative pregnancy test in female patients if applicable (childbearing potential who have received a reduced intensity conditioning regimen).
- Written informed consent and/or signed assent line from patient, parent or guardian.
- DONOR ELIGIBILITY: The donor for the CTL product will be the same donor who donated the allogeneic product for the patient's transplant. These donors for allogeneic (i.e. HLA matched or mismatched related or unrelated) stem cell transplants will have fulfilled eligibility for and consented to stem cell donation as per the stem cell transplant program's standard operating procedures.
Who cannot join
- Exclusion Criteria for initial CTL and for subsequent infusions:
- Patients receiving ATG, or Campath or other immunosuppressive T cell monoclonal antibodies within 28 days of screening for enrollment.
- Patients with other uncontrolled infections. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment.
- Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
- Patients who have received donor lymphocyte infusion (DLI) within 28 days.
- Patients with active acute GVHD grades II-IV.
- Active and uncontrolled relapse of malignancy.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Houston Methodist Hospital
Houston, Texas, 77030
Texas Children's Hospital
Houston, Texas, 77030
About this study
Official title: Administration of Rapidly Generated Multivirus-specific Cytotoxic T-Lymphocytes for the Prophylaxis and Treatment of EBV, CMV, and Adenovirus Infection Post Allogeneic Stem Cell Transplant (VIRAGE)
Patient's on this protocol have a type of blood cell cancer, other blood disease or a genetic disease and have received a stem cell transplant. The donor of the stem cells was either a brother or sister, another relative, or a closely matched unrelated donor. The patient is being asked to participate in this study which tests if blood cells from the donor that have been grown in a special way, can prevent or be an effective treatment for early infection by three viruses - Epstein Barr virus (EBV), cytomegalovirus (CMV) and adenovirus.
Adenovirus is a virus that usually causes symptoms of a common cold, but can cause serious life-threatening infections in patients who have weak immune systems. It can affect the lungs and cause very serious pneumonia, and can also damage the gut, liver, pancreas and eyes.CMV can also cause serious infections in patients with weak or suppressed immune systems. It usually affects the lungs, causing a very serious pneumonia, but it can also affect the gut, the liver and the eyes. Approximately 2/3 of normal people harbor this virus in their body. In healthy people CMV rarely causes any problems because the immune system can keep it under control, but after a transplant, the risk of developing CMV disease is much higher because the immune system is so weak. EBV is the virus that causes glandular fever. It is also a life long infection like CMV that is normally controlled by the immune system. When immunity is weak, the virus can become active and cause fevers, enlarged lymph nodes and sometimes a type of cancer called lymphoma.
Read more
Investigators want to see if a kind of white blood cell called T lymphocytes (T cells)can be used to prevent and treat adenovirus, CMV and EBV in the early stages of reactivation or infection. T cells have been grown from the patient's stem cell donor in the laboratory in a way that will train them to recognize the virus and control it when they are given after a transplant. This treatment with specially trained T cells (also called CTLs) has had activity against these viruses in previous studies and in this study investigators want to see if they still have activity when they are made in a simpler and faster way. These donor-derived multivirus-specific special cell lines are an investigational product not approved by the Food and Drug Administration.
The purpose of this study is to evaluate whether donor-derived multivirus-specific special cell lines are safe and can control three viruses: EBV, CMV and adenovirus.
Read the detailed description
Blood has been previously taken from the patient and the donor to make the cells.
To make the special cell line, special blood cells called dendritic cells (DCs)were made first from the donor blood. Then, a specially produced gene called a plasmid that carries the adenovirus, CMV, and EBV genes was introduced into the dendritic cells. Dendritic cells with these new genes are then mixed with T cells to stimulate them. This stimulation trains the donor T cells to kill cells that are infected with CMV, EBV, and adenovirus. Once a sufficient numbers of T cells were made, they were tested to make sure they killed the patient's cells infected with these viruses, but not the patient's normal cells, and were frozen.
If the donor has never been infected with CMV, the CTLs made for the patient may not have activity against a CMV infection. If these donor CTLs show no activity against CMV infection, the cells will not be given.
The patient may receive Benadryl (diphenhydramine) and Tylenol (acetaminophen). Then, the donor's special cells will be thawed and injected into the patient's intravenous line. After the patient receives the cells, the levels of these three viruses in the patient's blood will be monitored. Investigators will also take blood to see how long the T cells given to the patient are lasting in the patient's body.
If the special cell infusion has helped the infection or if the patient has had a treatment (for example with steroid drugs) that might have destroyed the T cells that were given to them, then the patient is allowed to receive up to 2 more doses of the cells.
The patient will continue to be followed by his/her transplant doctors after the injection. The patient will either be seen in the clinic or contacted by a research nurse to follow up for this study every week for 6 weeks then at 8 weeks, and 3, 6, and 12 months. The patient may have other visits for standard care.
The patient will also have regular blood tests done to follow counts and the viral infection. To learn more about the way the T cells are working in the patient's body, up to an extra 30-40 ml (6-8 teaspoons) of blood will be taken before the infusion and then at 1, 2, 4, 6, and 8 weeks and 3 months. Blood should come from the central intravenous line, and should not require extra needle sticks. Total time participation for this study will be 1 year.
- Conditions
- Adenovirus Infection, Epstein-Barr Virus Infections, Cytomegalovirus Infections, Stem Cell Transplant
- Being tested
- Multi-virus Specific T cells
- Keywords
- Epstein-Barr virus, CTL, cytotoxic T Lymphocytes, CMV, Adenovirus Infection, viral infection, hematopoietic stem cell transplantation
- Medical subject headings
- Adenoviridae Infections, Epstein-Barr Virus Infections, Cytomegalovirus Infections, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-virus Specific T cellsBiological
Subjects will receive Multivirus specific T cells on one of the following dose levels:
Level One: 5 x 10^6 rCTLs/m2
Level Two: 1 x 10^7 rCTLs/m2
Level Three: 2 x 10^7 rCTLs/m2
Level Four: 5 x 10^7 rCTLs/m2
If a patient has a partial response (as defined by a 50% fall in viral load) or receives medication (such as steroids) which may affect the persistence or function of the infused CTL they are eligible to receive up to 2 additional doses at the same initial dose. The minimum time between additional doses is 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A is for CMV seropositive donors. Receives: Biological: Multi-virus Specific T cells |
| Group B | Experimental | Group B is for CMV seronegative donors. Receives: Biological: Multi-virus Specific T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of dose limiting toxicity in subjects receiving rapidly-generated donor-derived multivirus-specific CTLs
Safety and toxicity outcomes including DLTs, GvHD, clinical signs of viral infections, secondary graft failure and laboratory measurements will be summarized using descriptive statistics for each dose level (frequency table, means, standard deviations, medians and ranges).
Measured: 42 days
Determine the effect of rCTL infusion on viral load
Primary endpoint for the phase II portion of the study is antiviral efficacy, and is whether the institution of additional antiviral therapy post rCTL is needed.
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 posted18 Feb 2010 (estimated)
- Study startJan 2011
- Primary completionMay 2013
- Study completionApr 2014
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 Adenovirus InfectionStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Methodist Hospital Research Institute, Center for Cell and Gene Therapy, Baylor College of Medicine
- Responsible party
- Principal investigator, Helen Heslop, Baylor College of Medicine
- Investigators
- Helen E Heslop, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01070797
- Sponsor's protocol ID
- 26374-VIRAGE
- Other IDs
- VIRAGE
- Status last verified
- Sep 2014
- First submitted
- 16 Feb 2010
- Last updated
- 4 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gerdemann U, Katari UL, Papadopoulou A, Keirnan JM, Craddock JA, Liu H, Martinez CA, Kennedy-Nasser A, Leung KS, Gottschalk SM, Krance RA, Brenner MK, Rooney CM, Heslop HE, Leen AM. Safety and clinical efficacy of rapidly-generated trivirus-directed T cells as treatment for adenovirus, EBV, and CMV infections after allogeneic hematopoietic stem cell transplant. Mol Ther. 2013 Nov;21(11):2113-21. doi: 10.1038/mt.2013.151. Epub 2013 Jun 20.
PubMed 23783429
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of Rapidly Generated Multivirus-specific Cytotoxic T-Lymphocytes for the Prophylaxis and Treatment of EBV, CMV, and Adenovirus Infection Post Allogeneic Stem Cell Transplant (VIRAGE)
- ClinicalTrials.gov ID
- NCT01070797
- Acronym / sponsor ID
- 26374-VIRAGE
- Conditions
- Adenovirus Infection, Epstein-Barr Virus Infections, Cytomegalovirus Infections, Stem Cell Transplant
- Keywords
- Epstein-Barr virus, CTL, cytotoxic T Lymphocytes, CMV, Adenovirus Infection, viral infection, hematopoietic stem cell transplantation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- The Methodist Hospital Research Institute, Center for Cell and Gene Therapy, Baylor College of Medicine
- Study start
- Jan 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 18 Feb 2010 (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.
Patient's on this protocol have a type of blood cell cancer, other blood disease or a genetic disease and have received a stem cell transplant. The donor of the stem cells was either a brother or sister, another relative, or a closely matched unrelated donor. The patient is being asked to participate in this study which tests if blood cells from the donor that have been grown in a special way, can prevent or be an effective treatment for early infection by three viruses - Epstein Barr virus (EBV), cytomegalovirus (CMV) and adenovirus.
Adenovirus is a virus that usually causes symptoms of a common cold, but can cause serious life-threatening infections in patients who have weak immune systems. It can affect the lungs and cause very serious pneumonia, and can also damage the gut, liver, pancreas and eyes.CMV can also cause serious infections in patients with weak or suppressed immune systems. It usually affects the lungs, causing a very serious pneumonia, but it can also affect the gut, the liver and the eyes. Approximately 2/3 of normal people harbor this virus in their body. In healthy people CMV rarely causes any problems because the immune system can keep it under control, but after a transplant, the risk of developing CMV disease is much higher because the immune system is so weak. EBV is the virus that causes glandular fever. It is also a life long infection like CMV that is normally controlled by the immune system. When immunity is weak, the virus can become active and cause fevers, enlarged lymph nodes and sometimes a type of cancer called lymphoma.
Investigators want to see if a kind of white blood cell called T lymphocytes (T cells)can be used to prevent and treat adenovirus, CMV and EBV in the early stages of reactivation or infection. T cells have been grown from the patient's stem cell donor in the laboratory in a way that will train them to recognize the virus and control it when they are given after a transplant. This treatment with specially trained T cells (also called CTLs) has had activity against these viruses in previous studies and in this study investigators want to see if they still have activity when they are made in a simpler and faster way. These donor-derived multivirus-specific special cell lines are an investigational product not approved by the Food and Drug Administration.
The purpose of this study is to evaluate whether donor-derived multivirus-specific special cell lines are safe and can control three viruses: EBV, CMV and adenovirus.
Detailed description
Blood has been previously taken from the patient and the donor to make the cells.
To make the special cell line, special blood cells called dendritic cells (DCs)were made first from the donor blood. Then, a specially produced gene called a plasmid that carries the adenovirus, CMV, and EBV genes was introduced into the dendritic cells. Dendritic cells with these new genes are then mixed with T cells to stimulate them. This stimulation trains the donor T cells to kill cells that are infected with CMV, EBV, and adenovirus. Once a sufficient numbers of T cells were made, they were tested to make sure they killed the patient's cells infected with these viruses, but not the patient's normal cells, and were frozen.
If the donor has never been infected with CMV, the CTLs made for the patient may not have activity against a CMV infection. If these donor CTLs show no activity against CMV infection, the cells will not be given.
The patient may receive Benadryl (diphenhydramine) and Tylenol (acetaminophen). Then, the donor's special cells will be thawed and injected into the patient's intravenous line. After the patient receives the cells, the levels of these three viruses in the patient's blood will be monitored. Investigators will also take blood to see how long the T cells given to the patient are lasting in the patient's body.
If the special cell infusion has helped the infection or if the patient has had a treatment (for example with steroid drugs) that might have destroyed the T cells that were given to them, then the patient is allowed to receive up to 2 more doses of the cells.
The patient will continue to be followed by his/her transplant doctors after the injection. The patient will either be seen in the clinic or contacted by a research nurse to follow up for this study every week for 6 weeks then at 8 weeks, and 3, 6, and 12 months. The patient may have other visits for standard care.
The patient will also have regular blood tests done to follow counts and the viral infection. To learn more about the way the T cells are working in the patient's body, up to an extra 30-40 ml (6-8 teaspoons) of blood will be taken before the infusion and then at 1, 2, 4, 6, and 8 weeks and 3 months. Blood should come from the central intravenous line, and should not require extra needle sticks. Total time participation for this study will be 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: Multi-virus Specific T cellsGroup A is for CMV seropositive donors. |
| Group B | Experimental | Biological: Multi-virus Specific T cellsGroup B is for CMV seronegative donors. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (21 listed)
- Patients will be eligible following any type of allogeneic transplant to receive CTLs as prophylaxis or for early reactivations as defined below.
- Prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using either bone marrow or peripheral blood stem cells.
- Prophylaxis for patients at risk of CMV, adenovirus or EBV infection (for Phase 2 portion only). In the phase 1 portion patients must meet criteria in 3 below.
- Early treatment of reactivation or infection which is defined for each virus as below:
- Early treatment may be given to eligible patients with a single or multiple infections. Patients with multiple infections with one reactivation and one controlled infection are eligible to enroll.
Key exclusion criteria (7 listed)
- Patients receiving ATG, or Campath or other immunosuppressive T cell monoclonal antibodies within 28 days of screening for enrollment.
- Patients with other uncontrolled infections. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment.
- Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
- Patients who have received donor lymphocyte infusion (DLI) within 28 days.
- Patients with active acute GVHD grades II-IV.
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 |
|---|---|---|
| Multi-virus Specific T cellsSubjects will receive Multivirus specific T cells on one of the following dose levels: Level One: 5 x 10^6 rCTLs/m2 Level Two: 1 x 10^7 rCTLs/m2 Level Three: 2 x 10^7 rCTLs/m2 Level Four: 5 x 10^7 rCTLs/m2 If a patient has a partial response (as defined by a 50% fall in viral load) or receives medication (such as steroids) which may affect the persistence or function of the infused CTL they are eligible to receive up to 2 additional doses at the same initial dose. The minimum time between additional doses is 28 days. | Biological | Group A, Group B |
Primary outcome
Assessment of dose limiting toxicity in subjects receiving rapidly-generated donor-derived multivirus-specific CTLs
Time frame: 42 days
Safety and toxicity outcomes including DLTs, GvHD, clinical signs of viral infections, secondary graft failure and laboratory measurements will be summarized using descriptive statistics for each dose level (frequency table, means, standard deviations, medians and ranges).
Determine the effect of rCTL infusion on viral load
Time frame: 1 year
Primary endpoint for the phase II portion of the study is antiviral efficacy, and is whether the institution of additional antiviral therapy post rCTL is needed.
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 4 Sep 2014.
- Derived from this study: PubMed 23783429Gerdemann U, Katari UL, Papadopoulou A, Keirnan JM, Craddock JA, Liu H, Martinez CA, Kennedy-Nasser A, Leung KS, Gottschalk SM, Krance RA, Brenner MK, Rooney CM, Heslop HE, Leen AM. Safety and clinical efficacy of rapidly-generated trivirus-directed T cells as treatment for adenovirus, EBV, and CMV infections after allogeneic hematopoietic stem cell transplant. Mol Ther. 2013 Nov;21(11):2113-21. doi: 10.1038/mt.2013.151. Epub 2013 Jun 20.
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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.
Helen E Heslop, MD principal investigator
Baylor College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Multi-virus Specific T cells in people with Adenovirus Infection and Epstein-Barr Virus Infections, run by Baylor College of Medicine at 2 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 21 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 4 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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 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?
Assessment of dose limiting toxicity in subjects receiving rapidly-generated donor-derived multivirus-specific CTLs (time frame: 42 days). The study lists 2 primary outcomes in all. 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 NCT01070797, 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 4 Sep 2014.