Alzheimer's DiseasePhase 1NCT01369225

Open Label Extension Study Evaluating Safety and Tolerability of AAB-003 (PF-05236812) in Subject With Mild to Moderate Alzheimer's Disease

A Phase 1 study testing AAB-003 (PF-05236812) in people with Alzheimer's Disease, run by Pfizer at 21 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a study to evaluate the safety and tolerability of multiple doses of AAB-003 (PF-05236812) in patients with mild to moderate Alzheimer's Disease. Patients who complete study B2601001 may participate in this trial and receive AAB-003 (PF-05236812). Each patient's participation will last approximately 52 weeks. Read more about this study

Who is it for?: Ages 50 to 90 years
Conditions the study is for: Alzheimer's Disease
What is being tested?: AAB-003 (PF-05236812)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 21 sitesin 2 countries
Study dates: Jul 2011to Aug 2014
Phase: Phase 1
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 50 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Successful completion of study B2601001
MMSE 12 or greater

Who cannot join

Study B2601001 Week 32 MRI with clinically important exclusionary findings.
Experienced SAE, vasogenic edema and/or intracranial hemorrhage in study B2601001

Trial locations and contacts

21 sites in 2 countries.

Country

City, postcode or hospital

21 sites in 2 countries

United States15 sites

Atlanta Center for Medical Research
Atlanta, Georgia, 30308
Foers Medical Arts Pharmacy
Bethesda, Maryland, 20814
Millennium Psychiatric Associates, LLC
Creve Coeur, Missouri, 63141
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, 07724
MD Clinical
Hallandale, Florida, 33009
Borgess Medical Center
Kalamazoo, Michigan, 49048
Borgess Research Institute
Kalamazoo, Michigan, 49048
KNI Southwest Michigan Imaging Center, LLC
Kalamazoo, Michigan, 49048
Central Jersey Radiology
Oakhurst, New Jersey, 07755
Munroe Regional Medical Center
Ocala, Florida, 34471
Renstar Medical Research
Ocala, Florida, 34471
Trinity Care Solutions
Ocala, Florida, 34471
Advanced Imaging of Ocala
Ocala, Florida, 34481
CBH Health, LLC
Rockville, Maryland, 20850
DePaul Health Center-MRI Department
St Louis, Missouri, 63044

Other trials in United States

South Korea6 sites

Inha University Hospital, Department of Neurology
Incheon, 400-711
Seoul National University Hospital, Department Neurology
Seongnam-si, Gyeonggi-do, 463-707
Samsung Medical Center, Department of Neurology
Seoul, 1350710
Korea University Anam Hospital IRB
Seoul, 136-705
ASAN Medical Center
Seoul, 138-736
Konkuk University Medical Center, Department of Neurology
Seoul, 143914

Other trials in South Korea

About this study

Official title: A Multicenter, Open-label Extension, Multiple Dose, Parallel Group Study To Investigate The Long-term Safety And Tolerability Of Aab-003 (Pf-05236812) Administered Intravenously In Subjects With Mild To Moderate Alzheimer's Disease Previously Treated With Aab-003 Or Placebo In Protocol B2601001

Conditions: Alzheimer's Disease
Being tested: AAB-003 (PF-05236812)
Keywords: Randomized, Safety Study, Open Label
Medical subject headings: Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AAB-003 (PF-05236812)Drug
0.5 mg/kg AAB-003, IV
AAB-003 (PF-05236812)Drug
1 mg/kg AAB-003, IV
AAB-003 (PF-05236812)Drug
2 mg/kg AAB-003, IV
AAB-003 (PF-05236812)Drug
4 mg/kg AAB-003, IV
AAB-003 (PF-05236812)Drug
8 mg/kg AAB-003, IV

Study groups in NCT01369225
Study group	Role	What they receive
0.5 mg/kg AAB-003	Experimental	Not described Receives: Drug: AAB-003 (PF-05236812)
1 mg/kg AAB-003	Experimental	Not described Receives: Drug: AAB-003 (PF-05236812)
2 mg/kg AAB-003	Experimental	Not described Receives: Drug: AAB-003 (PF-05236812)
4 mg/kg AAB-003	Experimental	Not described Receives: Drug: AAB-003 (PF-05236812)
8 mg/kg AAB-003	Experimental	Not described Receives: Drug: AAB-003 (PF-05236812)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.
Measured: Baseline up to Week 52
Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern
The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, RBC morphology, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (coagulation panel, circulating immune complex, and complement activation).
Measured: Baseline up to Week 52
Number of Participants With Potentially Clinically Important Vital Sign Findings
Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate <40 or >120 beats per minute (bpm); standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) of more than or equal to (>=)30 millimeters of mercury (mm Hg) change from baseline in same posture or SBP <90 mm Hg, diastolic blood pressure (DBP) >=20 mmHg change from baseline in same posture or DBP <50 mm Hg.
Measured: Baseline up to Week 52
Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings
ECG parameters included PR interval, QRS interval, and QT interval. Criteria for ECG changes meeting potential clinical concern included: PR interval >=300 milliseconds (msec) or >=25% increase when baseline is >200 msec and >=50% increase when baseline is less than or equal to (<=)200 msec; QRS interval >=200 msec or >=50% increase from baseline when baseline is less than or equal to 100 msec and >=25% increase when baseline is >100 msec; and QTcF >=450 msec or >=30 msec increase.
Measured: Baseline up to Week 52
Number of Participants With Abnormal Physical Examination Findings
A full physical examination consisted of an examination of the abdomen, genitourinary and cardiovascular systems, lungs, lymph nodes, mouth, musculoskeletal and neurological systems, skin, extremities, head, ears, eyes, nose, throat and thyroid gland. Criteria for abnormal physical findings was based on the investigator's discretion and any new physical examination findings were documented as AEs. Only sites with at least 1 participant abnormality are reported.
Measured: Baseline up to Week 52
Number of Participants With Abnormal Neurological Examination Findings
Neurological examinations were done to the extent needed to assess the subject for any potential changes in neurological status, as determined by the investigator. Examinations included level of consciousness, speech, cranial nerves, motor, sensory, coordination, gait, and tendon reflexes. Only tests with at least 1 participant abnormality are reported.
Measured: Baseline up to Week 52
Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. C-SSRS assesses whether participant experienced the following: completed suicide; suicide attempt; preparatory acts towards imminent suicidal behavior; suicidal ideation; self-injurious behavior, no suicidal intent. The results presented are the number of participants with completed suicide or non-fatal suicide events or behaviors. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.
Measured: Baseline up to Week 52
Number of Participants With Any New Magnetic Resonance Imaging (MRI) Findings
Brain MRIs were collected to assess for potential drug-related changes that might have constituted a safety concern. Findings suggestive of either vasogenic edema or intracranial hemorrhage were to be reported as AEs of special circumstance.
Measured: Baseline up to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2011Aug 2014

First posted8 Jun 2011 (estimated)
Study startJul 2011
Primary completionAug 2014
Study completionAug 2014

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
More trials run by PfizerThe 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: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01369225
Sponsor's protocol ID: B2601003
Status last verified: Jan 2017
First submitted: 10 May 2011
Last updated: 10 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Delnomdedieu M, Duvvuri S, Li DJ, Atassi N, Lu M, Brashear HR, Liu E, Ness S, Kupiec JW. First-In-Human safety and long-term exposure data for AAB-003 (PF-05236812) and biomarkers after intravenous infusions of escalating doses in patients with mild to moderate Alzheimer's disease. Alzheimers Res Ther. 2016 Mar 1;8(1):12. doi: 10.1186/s13195-016-0177-y.
PubMed 26925577

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Alzheimer's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Open-label Extension, Multiple Dose, Parallel Group Study To Investigate The Long-term Safety And Tolerability Of Aab-003 (Pf-05236812) Administered Intravenously In Subjects With Mild To Moderate Alzheimer's Disease Previously Treated With Aab-003 Or Placebo In Protocol B2601001
ClinicalTrials.gov ID: NCT01369225
Acronym / sponsor ID: B2601003
Conditions: Alzheimer's Disease
Keywords: Randomized, Safety Study, Open Label
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Collaborators: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Study start: Jul 2011
Primary completion: Aug 2014 (actual)
Study completion: Aug 2014 (actual)
First posted: 8 Jun 2011 (estimated)
Results: Posted 10 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
0.5 mg/kg AAB-003	Experimental	Drug: AAB-003 (PF-05236812)
1 mg/kg AAB-003	Experimental	Drug: AAB-003 (PF-05236812)
2 mg/kg AAB-003	Experimental	Drug: AAB-003 (PF-05236812)
4 mg/kg AAB-003	Experimental	Drug: AAB-003 (PF-05236812)
8 mg/kg AAB-003	Experimental	Drug: AAB-003 (PF-05236812)

Who may qualify

Ages: 50 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Successful completion of study B2601001
MMSE 12 or greater

Key exclusion criteria (2 listed)

Study B2601001 Week 32 MRI with clinically important exclusionary findings.
Experienced SAE, vasogenic edema and/or intracranial hemorrhage in study B2601001

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
AAB-003 (PF-05236812)0.5 mg/kg AAB-003, IV	Drug	0.5 mg/kg AAB-003
AAB-003 (PF-05236812)1 mg/kg AAB-003, IV	Drug	1 mg/kg AAB-003
AAB-003 (PF-05236812)2 mg/kg AAB-003, IV	Drug	2 mg/kg AAB-003
AAB-003 (PF-05236812)4 mg/kg AAB-003, IV	Drug	4 mg/kg AAB-003
AAB-003 (PF-05236812)8 mg/kg AAB-003, IV	Drug	8 mg/kg AAB-003

Primary outcome

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to Week 52
An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.
Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern
Time frame: Baseline up to Week 52
The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, RBC morphology, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (coagulation panel, circulating immune complex, and complement activation).
Number of Participants With Potentially Clinically Important Vital Sign Findings
Time frame: Baseline up to Week 52
Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate <40 or >120 beats per minute (bpm); standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) of more than or equal to (>=)30 millimeters of mercury (mm Hg) change from baseline in same posture or SBP <90 mm Hg, diastolic blood pressure (DBP) >=20 mmHg change from baseline in same posture or DBP <50 mm Hg.
Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings
Time frame: Baseline up to Week 52
ECG parameters included PR interval, QRS interval, and QT interval. Criteria for ECG changes meeting potential clinical concern included: PR interval >=300 milliseconds (msec) or >=25% increase when baseline is >200 msec and >=50% increase when baseline is less than or equal to (<=)200 msec; QRS interval >=200 msec or >=50% increase from baseline when baseline is less than or equal to 100 msec and >=25% increase when baseline is >100 msec; and QTcF >=450 msec or >=30 msec increase.
Number of Participants With Abnormal Physical Examination Findings
Time frame: Baseline up to Week 52
A full physical examination consisted of an examination of the abdomen, genitourinary and cardiovascular systems, lungs, lymph nodes, mouth, musculoskeletal and neurological systems, skin, extremities, head, ears, eyes, nose, throat and thyroid gland. Criteria for abnormal physical findings was based on the investigator's discretion and any new physical examination findings were documented as AEs. Only sites with at least 1 participant abnormality are reported.
Number of Participants With Abnormal Neurological Examination Findings
Time frame: Baseline up to Week 52
Neurological examinations were done to the extent needed to assess the subject for any potential changes in neurological status, as determined by the investigator. Examinations included level of consciousness, speech, cranial nerves, motor, sensory, coordination, gait, and tendon reflexes. Only tests with at least 1 participant abnormality are reported.
Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline up to Week 52
The C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. C-SSRS assesses whether participant experienced the following: completed suicide; suicide attempt; preparatory acts towards imminent suicidal behavior; suicidal ideation; self-injurious behavior, no suicidal intent. The results presented are the number of participants with completed suicide or non-fatal suicide events or behaviors. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.
Number of Participants With Any New Magnetic Resonance Imaging (MRI) Findings
Time frame: Baseline up to Week 52
Brain MRIs were collected to assess for potential drug-related changes that might have constituted a safety concern. Findings suggestive of either vasogenic edema or intracranial hemorrhage were to be reported as AEs of special circumstance.

Results and safety

Results posted to the registry on 10 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AAB-003 0.5 mg/kg	6	4
AAB-003 1 mg/kg	3	3
AAB-003 2 mg/kg	12	9
AAB-003 4 mg/kg	10	8
AAB-003 8 mg/kg	12	10
Placebo/AAB-003	9	9

Primary outcome: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: Baseline up to Week 52. Number. Unit: participants

Measure	AAB-003 0.5 mg/kg n = 6	AAB-003 1 mg/kg n = 3	AAB-003 2 mg/kg n = 12	AAB-003 4 mg/kg n = 10	AAB-003 8 mg/kg n = 12	Placebo/AAB-003 n = 9
Number of Participants with AEs	5	3	9	5	10	8
Number of Participants with SAEs	0	1	2	3	1	1

Population analysed: The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).

Primary outcome: Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern

Time frame: Baseline up to Week 52. Number. Unit: participants

Measure	AAB-003 0.5 mg/kg n = 6	AAB-003 1 mg/kg n = 3	AAB-003 2 mg/kg n = 12	AAB-003 4 mg/kg n = 10	AAB-003 8 mg/kg n = 12	Placebo/AAB-003 n = 9
Value	3	2	8	7	10	6

Population analysed: The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).

Primary outcome: Number of Participants With Potentially Clinically Important Vital Sign Findings

Time frame: Baseline up to Week 52. Number. Unit: participants

Measure	AAB-003 0.5 mg/kg n = 6	AAB-003 1 mg/kg n = 3	AAB-003 2 mg/kg n = 12	AAB-003 4 mg/kg n = 10	AAB-003 8 mg/kg n = 12	Placebo/AAB-003 n = 9
Supine SBP <90 mm Hg	1	0	0	0	0	1
Supine DBP <50 mm Hg	0	0	1	3	0	0
Supine Pulse Rate <40 or >120 bpm	0	0	0	0	1	0
Supine SBP >=30 mm Hg Increase from Baseline	3	1	1	2	4	1
Supine DBP >=20 mm Hg Increase from Baseline	2	1	4	5	1	2
Supine SBP >=30 mm Hg Decrease from Baseline	0	1	4	1	2	4
Supine DBP >=20 mm Hg Decrease from Baseline	0	1	5	3	3	5

Population analysed: The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).

Primary outcome: Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings

Time frame: Baseline up to Week 52. Number. Unit: participants

Measure	AAB-003 0.5 mg/kg n = 6	AAB-003 1 mg/kg n = 3	AAB-003 2 mg/kg n = 12	AAB-003 4 mg/kg n = 10	AAB-003 8 mg/kg n = 12	Placebo/AAB-003 n = 9
PR Interval >=300 msec	0	0	0	0	0	0
QRS Complex >=200 msec	0	0	0	0	0	0
QTcF Interval 450 to <480 msec	0	2	4	3	2	2
QTcF Interval 480 to <500 msec	0	0	1	1	1	0
QTcF Interval >=500 msec	0	0	1	0	0	0
PR Interval >=25/50% Increase from Baseline	0	0	0	0	0	0
QRS Complex >=25/50% Increase from Baseline	0	0	0	0	0	0
QTcF Interval >=30/<60 msec Change from Baseline	2	1	4	4	1	2

Population analysed: The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).

Adverse events

Time frame: Baseline up to Week 52. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AAB-003 0.5 mg/kg	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
AAB-003 1 mg/kg	1 of 3 (33.3%)	3 of 3 (100%)	Not reported
AAB-003 2 mg/kg	2 of 12 (16.7%)	9 of 12 (75%)	Not reported
AAB-003 4 mg/kg	3 of 10 (30%)	4 of 10 (40%)	Not reported
AAB-003 8 mg/kg	1 of 12 (8.3%)	10 of 12 (83.3%)	Not reported
Placebo/AAB-003	1 of 9 (11.1%)	8 of 9 (88.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26925577Delnomdedieu M, Duvvuri S, Li DJ, Atassi N, Lu M, Brashear HR, Liu E, Ness S, Kupiec JW. First-In-Human safety and long-term exposure data for AAB-003 (PF-05236812) and biomarkers after intravenous infusions of escalating doses in patients with mild to moderate Alzheimer's disease. Alzheimers Res Ther. 2016 Mar 1;8(1):12. doi: 10.1186/s13195-016-0177-y.
To obtain contact information for a study center near you, click here.Link 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.

Pfizer CT.gov Call Center study director

Pfizer

21 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AAB-003 (PF-05236812) in people with Alzheimer's Disease, run by Pfizer at 21 sites in 2 countries.

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 2 inclusion and 2 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 10 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 21 sites in United States, South Korea. 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?

Yes. Results are posted in the registry (first posted 10 Mar 2017). 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?

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Baseline up to Week 52). The study lists 8 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 NCT01369225, 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 10 Mar 2017; AzTrials last refreshed its copy on 6 Nov 2026.