Multiple SclerosisPhase 1NCT01143441
Investigating Mechanism of Action of DAC HYP in the Treatment of High-Inflammatory Multiple Sclerosis (MS)
A Phase 1 study testing DAC-HYP in people with Multiple Sclerosis and Multiple Sclerosis, Relapsing-Remitting, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Objective: The primary goal of this study is to investigate the mechanism of action (MOA) of CD25-blocking therapies in high inflammatory multiple sclerosis (HI-MS). The secondary goal of this study is to assess long-term safety and efficacy of CD25-blocking therapies in HI-MS. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- DAC-HYP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2010to 11 Aug 2017
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- MS as defined by the modified McDonald criteria (Polman, Reingold et al. 2005)
- HI-MS (RR-MS or SP-MS) before initiation of daclizumab therapy, defined as:
- greater than or equal to 3 CEL on a single pre-daclizumab MRI or
- greater than or equal to 1 MS exacerbation per year before initiation of daclizumab therapy or
- progression of sustained disability by greater than or equal to 1.0 point on the expanded disability status scale (EDSS) in the year preceding daclizumab therapy
- Age 18-60, inclusive
Show all 14Show fewer
- EDSS 0 to 6.0, inclusive
- Able to provide informed consent
- Willing to participate in all aspects of trial design and follow-up
- Females of childbearing potential are willing to commit to the use of a reliable method of birth control (i.e., hormonal contraception including birth control pills, injected hormones or vaginal ring; intrauterine device; barrier methods with spermicide, specifically diaphragms or condoms they have undergone surgical sterilization, such as hysterectomy or tubal ligation) for the duration of the study and continued 4 months after conclusion of the study.
- ADDITIONAL INCLUSION CRITERION FOR THE LONG-TERM DACLIZUMAB THERAPY COHORT ONLY:
- -IV daclizumab therapy for at least 1 year with a treatment response consisting of:<TAB>
- greater than or equal to 70% reduction of CEL after starting daclizumab; or
- stabilization or improvement of sustained neurological disability on daclizumab.
Who cannot join
- PP-MS or low-inflammatory SP-MS
- Alternative diagnoses that can explain neurological disability and MRI findings (e.g., ischemia/gliosis, CNS lyme disease, SLE, sarcoidosis, etc.)
- History of malignancy, with the following exceptions: excised or treated basal cell carcinoma or fewer than 3 squamous cell carcinomas, grade 1 endometrial carcinomas treated with total hysterectomy and without evidence for recurrence for greater than or equal to 3 years
- Clinically significant medical disorders that, in the judgment of the investigators, could cause CNS tissue damage or limit its repair, expose the patient to undue risk of harm or prevent the patient from completing the study (e.g., immunodeficiency disorders, other autoimmune or immune-mediated disorders or chronic infections). Specific exclusions (based on baseline laboratory evaluation) are:
- positive HIV or HTLV-1 serology;
- positive hepatitis B or C serology;
Show all 65Show fewer
- pregnant or breastfeeding female;
- known history of severe allergic or anaphylactic reactions;
- known hypersensitivity to study drug or its excipients;
- varicella or herpes zoster virus infection or any severe viral infection within the 6 weeks prior to screening; or
- exposure to varicella zoster virus within 21 days before screening.
- Abnormal screening/baseline blood tests exceeding any of the limits defined below:
- serum alanine aminotransferase/serum glutamate pyruvate transaminase (ALT/SGPT), aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT), or gamma-glutamyl-transferase greater than or equal to 2 times the upper limit of normal (ULN);
- total white blood cell count <3,000/mm(3);
- hemoglobin greater than or equal to 9.0 g/dL;
- platelets greater than or equal to 100 x 10(9)/L;
- lymphocytes greater than or equal to 1.0 x 10(9)/L;
- neutrophils greater than or equal to 1.5 x 10(9)/L;
- serum creatinine greater than or equal to the ULN.
- Any of the following treatment history:
- any type of live virus vaccine in the 4 weeks prior to initiation of therapy, including but not limited to: measles/mumps/rubella vaccine, varicella zoster virus vaccine, oral polio vaccine, and nasal influenza vaccine;
- infection (viral, fungal, bacterial) requiring hospitalization or intravenous (IV) antibiotics within the 8 weeks prior to initiation of therapy;
- another investigational drug or approved therapy for investigational use (except daclizumab) within the 6 months prior to initiation of therapy.
- Prior treatment with the any of the following:
- total lymphoid irradiation;
- cladribine;
- T cell or T cell receptor vaccination; or
- any therapeutic monoclonal antibody, except natalizumab and daclizumab.
- Prior treatment with any of the following medications or procedures within 1 year prior to initiation of therapy:
- mitoxantrone;
- cyclophosphamide;
- fingolimod; or
- natalizumab.
- Prior treatment with any of the following medications or procedures within 6 months prior to initiation of therapy:
- cyclosporine;
- azathioprine;
- methotrexate;
- mycophenolate mofetil;
- intravenous immunoglobulin (IVIg); or
- plasmapheresis or cytapheresis.
- Treatment with any of the following medications within the 30 days prior to initiation of therapy:
- IV corticosteroid treatment;
- oral corticosteroid treatment;
- glatiramer acetate; or
- interferon-beta
- For immunizations studies, known history of hypersensitivity or severe allergic reaction to vaccine components (subjects with such history can participate in the trial, but will not be immunized)
- For patients in the extension phase: Patients may be excluded if they did not demonstrate an adequate clinical response in the first phase of the trial while receiving DAC HYP.
- Inclusion criteria for MS controls for immunization and skin biopsy studies:
- MS as defined by the modified McDonald criteria
- RR-MS or SP-MS
- Age 18-60, inclusive
- EDSS 0 to 7.0, inclusive
- Able to provide informed consent
- Willing to participate in all aspects of trial design and follow-up
- Exclusion criteria for MS controls for immunization and skin biopsy studies:
- Treatment with immunomodulatory therapies that may have a negative impact on development of antigen-specific responses after immunization, including steroids within the last 60 days before the immunization study
- Clinically significant medical disorders that, in the judgment of the investigators, could invalidate the person as appropriate control (e.g., immunodeficiency disorders, other autoimmune or immunemediated disorders or chronic infections). Specific exclusions (based on baseline laboratory evaluation) are:
- positive HIV or HTLV-1 serology;
- positive hepatitis B or C serology;
- pregnant or breastfeeding female;
- known history of severe allergic or anaphylactic reactions to vaccine components;
- Abnormal screening/baseline blood tests exceeding any of the limits defined below:
- serum alanine aminotransferase/serum glutamate pyruvate transaminase (ALT/SGPT), aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT), or gamma-glutamyl-transferase (Bullet)2 times the upper limit of normal (ULN);
- total white blood cell count <3,000/mm3;
- hemoglobin less than or equal to 9.0 g/dL
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Objective:
The primary goal of this study is to investigate the mechanism of action (MOA) of CD25-blocking therapies in high inflammatory multiple sclerosis (HI-MS). The secondary goal of this study is to assess long-term safety and efficacy of CD25-blocking therapies in HI-MS.
Read more
Study population:
Two cohorts of patients will be enrolled:
- Long-term daclizumab therapy cohort: Up to 15 daclizumab-treated patients with relapsing-remitting (RR-MS) or secondary-progressive MS (SP-MS) previously classified as HI-MS based on MRI/clinical criteria, who have been treated with IV daclizumab for a minimum of 1 year and responded to this therapy with significant (>70%) decrease in contrast-enhancing lesions (CEL) or stabilization/improvement of disease activity (>60% decrease in MS relapses and stable or improved EDSS disability score).
- New treatment cohort: Up to 15 HI-MS patients (RR- or SP-MS) with inadequate therapeutic response to first-line, FDA-approved immunomodulatory therapies for MS or who cannot, for any reason, be treated with first-line, FDA-approved immunomodulatory therapies for MS.
Design:
This is an open label, Phase I trial of 150 mg of daclizumab high yield process (DAC HYP) administered subcutaneously (SC) every 4 weeks for a total of 3 years.
Outcome measures:
Because the main goal of this study is to investigate the MOA of CD25-blocking therapies in MS, the primary outcomes are mechanistic immunological studies performed on clinical samples (peripheral blood mononuclear cells (PBMC), cerebrospinal fluid (CSF) cells and skin biopsies) derived from DAC HYP-treated patients. The secondary outcome measure is long-term safety and tolerability of subcutaneous DAC HYP in HI-MS patients.
Read the detailed description
Objective:
The primary goal of this study is to investigate the mechanism of action (MOA) of CD25-blocking therapies in high inflammatory multiple sclerosis (HI-MS). The secondary goal of this study is to assess long-term safety and efficacy of CD25-blocking therapies in HI-MS.
Study population:
We will enroll up to 70 patients. We expect to screen up to 40 HI-MS participants to yield 31 patients that will receive study drug. Two cohorts of patients will be enrolled for the treatment part of the protocol: A. Long-term daclizumab therapy cohort: 16 daclizumab-treated patients with relapsing-remitting (RR-MS) or secondary-progressive MS (SP-MS) previously classified as HI-MS based on MRI/clinical criteria, who have been treated with IV daclizumab for a minimum of 1 year and responded to this therapy with significant (>70%) decrease in contrast-enhancing lesions (CEL) or stabilization/improvement of disease activity (>60% decrease in MS relapses and stable or improved EDSS disability score). B. New treatment cohort: 15 HI-MS patients (RR- or SP-MS) with inadequate therapeutic response to first-line, FDA-approved immunomodulatory therapies for MS or who choose not to, for any reason, be treated with first-line, FDAapproved immunomodulatory therapies for MS. Up to 30 subjects with inflammatory MS will be screened to yield 20 controls for immunization and skin biopsy studies (Cohort C: MS controls).
Design:
This is an open label, Phase I trial of 150 mg of daclizumab high yield process (DAC HYP) administered subcutaneously (SC) every 4 weeks for a total of 3 years.
Outcome measures:
Because the main goal of this study is to investigate the MOA of CD25-blocking therapies in MS, the primary outcomes are mechanistic immunological studies performed on clinical samples (peripheral blood mononuclear cells (PBMC), cerebrospinal fluid (CSF) cells and skin biopsies) derived from DAC HYP-treated patients. The secondary outcome measure is long-term safety and tolerability of subcutaneous DAC HYP in HI-MS patients.
- Being tested
- DAC-HYP
- Keywords
- Multiple Sclerosis, Daclizumab
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAC-HYPBiological
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Long-Term daclizumab cohort Receives: Biological: DAC-HYP |
| Cohort B | Experimental | New Treatment Cohort Receives: Biological: DAC-HYP |
| Cohort C | No intervention | MS Controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expansion of CD56bright NK cells.
Contraction of lymphoid tissue inducer cells (LTi) cells.
Expansion of double negative T cells.
Secondary outcomes (2)
Long-term safety and tolerability of DAC HYP in high-inflammatory multiple sclerosis (HI-MS) patients who were either previously successfully treated with Zenapax (registered trademark) or without any previous exposure to DC25-targeting therapie...
Measured: Study Completion
Secondary Outcome Measure: MRI outcomes Inhibition of the number of contrast-enhancing lesions. T2 lesion load and development of new MS lesions. Clinical/functional outcomesChange in EDSS. Change in Scripps NRS. Change in MSFC.Change in S...
Measured: Study Completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2010 (estimated)
- Study start13 May 2010
- Primary completion11 Aug 2017
- Study completion11 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Bibiana Bielekova, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01143441
- Sponsor's protocol ID
- 100125
- Other IDs
- 10-N-0125
- Status last verified
- 11 Aug 2017
- First submitted
- 11 Jun 2010
- Last updated
- 1 Nov 2019
- Results posted
- No
Publications
Bielekova B, Howard T, Packer AN, Richert N, Blevins G, Ohayon J, Waldmann TA, McFarland HF, Martin R. Effect of anti-CD25 antibody daclizumab in the inhibition of inflammation and stabilization of disease progression in multiple sclerosis. Arch Neurol. 2009 Apr;66(4):483-9. doi: 10.1001/archneurol.2009.50.
PubMed 19364933Hanssen LE, Schrumpf E, Kolbenstvedt AN, Tausjo J, Dolva LO. Recombinant alpha-2 interferon with or without hepatic artery embolization in the treatment of midgut carcinoid tumours. A preliminary report. Acta Oncol. 1989;28(3):439-43. doi: 10.3109/02841868909111219.
PubMed 2742781Bielekova B, Catalfamo M, Reichert-Scrivner S, Packer A, Cerna M, Waldmann TA, McFarland H, Henkart PA, Martin R. Regulatory CD56(bright) natural killer cells mediate immunomodulatory effects of IL-2Ralpha-targeted therapy (daclizumab) in multiple sclerosis. Proc Natl Acad Sci U S A. 2006 Apr 11;103(15):5941-6. doi: 10.1073/pnas.0601335103. Epub 2006 Apr 3.
PubMed 16585503
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Mechanism of Action of DAC HYP in the Treatment of High-Inflammatory Multiple Sclerosis (MS)
- ClinicalTrials.gov ID
- NCT01143441
- Acronym / sponsor ID
- 100125
- Keywords
- Multiple Sclerosis, Daclizumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 13 May 2010
- Primary completion
- 11 Aug 2017 (actual)
- Study completion
- 11 Aug 2017 (actual)
- First posted
- 14 Jun 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.
Objective:
The primary goal of this study is to investigate the mechanism of action (MOA) of CD25-blocking therapies in high inflammatory multiple sclerosis (HI-MS). The secondary goal of this study is to assess long-term safety and efficacy of CD25-blocking therapies in HI-MS.
Study population:
Two cohorts of patients will be enrolled:
- Long-term daclizumab therapy cohort: Up to 15 daclizumab-treated patients with relapsing-remitting (RR-MS) or secondary-progressive MS (SP-MS) previously classified as HI-MS based on MRI/clinical criteria, who have been treated with IV daclizumab for a minimum of 1 year and responded to this therapy with significant (>70%) decrease in contrast-enhancing lesions (CEL) or stabilization/improvement of disease activity (>60% decrease in MS relapses and stable or improved EDSS disability score).
- New treatment cohort: Up to 15 HI-MS patients (RR- or SP-MS) with inadequate therapeutic response to first-line, FDA-approved immunomodulatory therapies for MS or who cannot, for any reason, be treated with first-line, FDA-approved immunomodulatory therapies for MS.
Design:
This is an open label, Phase I trial of 150 mg of daclizumab high yield process (DAC HYP) administered subcutaneously (SC) every 4 weeks for a total of 3 years.
Outcome measures:
Because the main goal of this study is to investigate the MOA of CD25-blocking therapies in MS, the primary outcomes are mechanistic immunological studies performed on clinical samples (peripheral blood mononuclear cells (PBMC), cerebrospinal fluid (CSF) cells and skin biopsies) derived from DAC HYP-treated patients. The secondary outcome measure is long-term safety and tolerability of subcutaneous DAC HYP in HI-MS patients.
Detailed description
Objective:
The primary goal of this study is to investigate the mechanism of action (MOA) of CD25-blocking therapies in high inflammatory multiple sclerosis (HI-MS). The secondary goal of this study is to assess long-term safety and efficacy of CD25-blocking therapies in HI-MS.
Study population:
We will enroll up to 70 patients. We expect to screen up to 40 HI-MS participants to yield 31 patients that will receive study drug. Two cohorts of patients will be enrolled for the treatment part of the protocol: A. Long-term daclizumab therapy cohort: 16 daclizumab-treated patients with relapsing-remitting (RR-MS) or secondary-progressive MS (SP-MS) previously classified as HI-MS based on MRI/clinical criteria, who have been treated with IV daclizumab for a minimum of 1 year and responded to this therapy with significant (>70%) decrease in contrast-enhancing lesions (CEL) or stabilization/improvement of disease activity (>60% decrease in MS relapses and stable or improved EDSS disability score). B. New treatment cohort: 15 HI-MS patients (RR- or SP-MS) with inadequate therapeutic response to first-line, FDA-approved immunomodulatory therapies for MS or who choose not to, for any reason, be treated with first-line, FDAapproved immunomodulatory therapies for MS. Up to 30 subjects with inflammatory MS will be screened to yield 20 controls for immunization and skin biopsy studies (Cohort C: MS controls).
Design:
This is an open label, Phase I trial of 150 mg of daclizumab high yield process (DAC HYP) administered subcutaneously (SC) every 4 weeks for a total of 3 years.
Outcome measures:
Because the main goal of this study is to investigate the MOA of CD25-blocking therapies in MS, the primary outcomes are mechanistic immunological studies performed on clinical samples (peripheral blood mononuclear cells (PBMC), cerebrospinal fluid (CSF) cells and skin biopsies) derived from DAC HYP-treated patients. The secondary outcome measure is long-term safety and tolerability of subcutaneous DAC HYP in HI-MS patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Biological: DAC-HYPLong-Term daclizumab cohort |
| Cohort B | Experimental | Biological: DAC-HYPNew Treatment Cohort |
| Cohort C | No intervention | –MS Controls |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- MS as defined by the modified McDonald criteria (Polman, Reingold et al. 2005)
- HI-MS (RR-MS or SP-MS) before initiation of daclizumab therapy, defined as:
- -IV daclizumab therapy for at least 1 year with a treatment response consisting of:<TAB>
- greater than or equal to 70% reduction of CEL after starting daclizumab; or
- stabilization or improvement of sustained neurological disability on daclizumab.
Key exclusion criteria (65 listed)
- PP-MS or low-inflammatory SP-MS
- Alternative diagnoses that can explain neurological disability and MRI findings (e.g., ischemia/gliosis, CNS lyme disease, SLE, sarcoidosis, etc.)
- History of malignancy, with the following exceptions: excised or treated basal cell carcinoma or fewer than 3 squamous cell carcinomas, grade 1 endometrial carcinomas treated with total hysterectomy and without evidence for recurrence for greater than or equal to 3 years
- Clinically significant medical disorders that, in the judgment of the investigators, could cause CNS tissue damage or limit its repair, expose the patient to undue risk of harm or prevent the patient from completing the study (e.g., immunodeficiency disorders, other autoimmune or immune-mediated disorders or chronic infections). Specific exclusions (based on baseline laboratory evaluation) are:
- Abnormal screening/baseline blood tests exceeding any of the limits defined below:
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 |
|---|---|---|
| DAC-HYP | Biological | Cohort A, Cohort B |
Primary outcome
Expansion of CD56bright NK cells.
Contraction of lymphoid tissue inducer cells (LTi) cells.
Expansion of double negative T cells.
2 secondary outcomes
Long-term safety and tolerability of DAC HYP in high-inflammatory multiple sclerosis (HI-MS) patients who were either previously successfully treated with Zenapax (registered trademark) or without any previous exposure to DC25-targeting therapie...
Time frame: Study Completion
Secondary Outcome Measure: MRI outcomes Inhibition of the number of contrast-enhancing lesions. T2 lesion load and development of new MS lesions. Clinical/functional outcomesChange in EDSS. Change in Scripps NRS. Change in MSFC.Change in S...
Time frame: Study Completion
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 1 Nov 2019.
- Background: PubMed 19364933Bielekova B, Howard T, Packer AN, Richert N, Blevins G, Ohayon J, Waldmann TA, McFarland HF, Martin R. Effect of anti-CD25 antibody daclizumab in the inhibition of inflammation and stabilization of disease progression in multiple sclerosis. Arch Neurol. 2009 Apr;66(4):483-9. doi: 10.1001/archneurol.2009.50.
- Background: PubMed 2742781Hanssen LE, Schrumpf E, Kolbenstvedt AN, Tausjo J, Dolva LO. Recombinant alpha-2 interferon with or without hepatic artery embolization in the treatment of midgut carcinoid tumours. A preliminary report. Acta Oncol. 1989;28(3):439-43. doi: 10.3109/02841868909111219.
- Background: PubMed 16585503Bielekova B, Catalfamo M, Reichert-Scrivner S, Packer A, Cerna M, Waldmann TA, McFarland H, Henkart PA, Martin R. Regulatory CD56(bright) natural killer cells mediate immunomodulatory effects of IL-2Ralpha-targeted therapy (daclizumab) in multiple sclerosis. Proc Natl Acad Sci U S A. 2006 Apr 11;103(15):5941-6. doi: 10.1073/pnas.0601335103. Epub 2006 Apr 3.
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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.
Bibiana Bielekova, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
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 DAC-HYP in people with Multiple Sclerosis and Multiple Sclerosis, Relapsing-Remitting, run by National Institute of Neurological Disorders and Stroke (NINDS) 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 14 inclusion and 65 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 1 Nov 2019. 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 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?
Expansion of CD56bright NK cells.. 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?
On the ClinicalTrials.gov record for NCT01143441, which also lists 3 linked publications.
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 1 Nov 2019.