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ACE-011-DBA: Safety and Efficacy Study of Sotatercept in Adults With Transfusion Dependent Diamond Blackfan Anemia

Sponsor
Northwell Health (Other)
Overall Status
Terminated
CT.gov ID
NCT01464164
Collaborator
(none)
19
Enrollment
1
Location
2
Arms
111.4
Actual Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the safety and dosing of drug Sotatercept, as a subcutaneous injection, to stimulate production of red blood cell production. To be given every 28 days for up to four doses.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Detailed Description

This study is for adult patients with Diamond Blackfan Anemia who are currently being transfused every 3- 4 weeks.

The drug will be given as a subcutaneous injection within one of three dose levels. The first dose level (0.1 mg/kg) will include 3 subjects who will receive the same dose of the drug monthly for a total of 4 doses, as long as there are no dose- limiting toxicities (DLTs). A Dose limiting toxicity is defined as inability to deliver the scheduled doses because of toxicity >/= Grade 3, according to NCI Toxicity Grading Scale.

Once all 3 subjects have received and tolerated the low dose level, the next level will open (0.3 mg/kg)to 3 new subjects. Subjects will be monitored closely for response and side effects.

If more than 2 subjects have a dose limiting toxicity in the first dose level, then dose level -1 (0.05 mg/kg)will open, enrolling 3 more subjects. If more than 2 subjects at dose level -1, have dose limiting toxicities, the study will be discontinued. If there are no additional dose limiting toxicities, dose level -1 will be the maximum tolerated dose.

There are a total of 3 dose levels, not including dose level -1. Once the maximum tolerated dose has been reached, up to a total of 10 additional subjects will be enrolled.

Protocol Amendment: The protocol has been amended to include an additional enrollment of 20 subjects with two additional dose levels of Sotatercept (0.075 mg/kg and 0.100 mg/kg ) to be given with or without a prednisone boost.

Efficacy will be measured by response. A complete response will be determined if the subject no longer requires transfusion, while on study drug. A partial response will be measured by a reduction by 50% in need for transfusion.

Treatment modifications will be made based on evidence of side effects. Dose- escalation will be performed only if no side effects are reported and no efficacy is evidenced. Treatment will be stopped if hemoglobin is >12 gm/dl and/ or any >/+ grade 3 adverse event is related to sotatercept.

Study assessments will include:

  • Physical exam (height, weight, vital signs and blood pressure)at screening, day 1 of each cycle and monthly for 3 months of follow up period as well as at study discontinuation.

  • Additional blood pressure monitoring at day 1 of each cycle and weekly there after through cycle 4, monthly in follow up period and at study discontinuation.

  • Karnofsky performance status at screening, day 1 of cycle 2 and day 1 of monthly follow up period for 3 months and study discontinuation.

  • CBC reticulocyte count and ANC will be collected at day 1 of each cycle and weekly there after through cycle 4, monthly in follow up period and at study discontinuation.

  • Blood chemistry, liver and kidney function will be assessed at screening, day 1 and 15 of cycle 1, day 1 of cycle 2, 3, 4 month 1 in follow up and at study discontinuation.

  • Blood for iron status (serum iron, transferrin and %, ferritin) will be collected during the screening period, and at month 1 of the follow-up period as well as study discontinuation.

  • Folate and B12 levels will be assessed during the screening period at day 1 of cycle 3 and again at study discontinuation.

  • Urinalysis (creatinine, protein),at screening, day 15 of cycle 1, day 1 of cycles 2, 3, and 4 monthly during follow-up and at study discontinuation.

  • Serum erythropoietin at screening, day 15 of cycle 1, day 1 of cycle 3, monthly during follow-up and at study discontinuation.

  • FSH & LH (everyone), DHEA & testosterone (males only), estrogen & estradiol (females only)at screening, day 1 of cycles 2, 3, and 4, monthly during follow- up period and at study discontinuation.

  • EKG & ECHO at screening, day 1 of cycle 3 first month of follow-up period and at study discontinuation

  • Dexa Scan at screening, day 1 of monthly follow-up period and at study discontinuation

  • Transfusion assessment at screening, day 1, 8, 15 and 22 of cycle 1, day 1 and 15 of cycles 2, 3, and 4, monthly during follow-up period and at study discontinuation.

  • Response assessment at day 8, 15, 22 of cycle 1, day 1 and 15 of cycles2, 3, and 4, monthly for 3 months during follow-up period and at study discontinuation

  • Adverse events, concomitant therapies to be assessed at day 1, 8, 15, and 22 of cycle 1, day 1 and 15 of cycles 2, 3, and 4, monthly during follow-up period and at study discontinuation

  • Drug administration day 1 of cycles 1, 2, 3, and 4.

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I/II, Open-Label Study to Determine Safety and Efficacy of Sotatercept (ACE-011) in Adults With Red Blood Cell Transfusion- Dependent Diamond Blackfan Anemia
Actual Study Start Date :
Jan 1, 2012
Actual Primary Completion Date :
Apr 13, 2021
Actual Study Completion Date :
Apr 13, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sotatercept

Sotatercept to be given as a subcutaneous injection once a month for 4 consecutive months, using a dose escalation scale among 3 cohorts. *Protocol Amendment: Two additional cohorts will be given Sotatercept 0.75mg/kg and 1 mg/kg as a subcutaneous injection once every 3 weeks.

Drug: Sotatercept
Cohort 4a: 3 patients on Sotatercept 0.75 mg/kg every 3 weeks. If the patients have no untoward events in the Patients in Dose Level 4 by the end of 3 of the 6 doses, then additional patients (Dose Level 5) will be enrolled at the next dose level: Cohort 5a: 3 patients on Sotatercept 1 mg/kg every 3 weeks
Other Names:
  • ACE-011

    		•
    Experimental: Sotatercept with prednisone boost

    Protocol Amendment: Two additional cohorts will be given Sotatercept 0.75mg/kg and 1 mg/kg as a subcutaneous injection once every 3 weeks along with a prednisone boost of 1 mg/kg daily for 3 weeks (max of 60 mg).

    Drug: Sotatercept with prednisone boost
    Cohort 4b: 3 patients on Sotatercept 0.75 mg/kg every 3 weeks with a three week prednisone boost of 1 mg/kg/day (max 60 mg). If the patients have no untoward events in the Patients in Dose Level 4 by the end of 3 of the 6 doses, then additional patients (Dose Level 5) will be enrolled at the next dose level: Cohort 5b: 3 patients on Sotatercept 1 mg/kg every 3 weeks with a 3 week prednisone boost of 1 mg/kg/day (max 60 mg).
    Other Names:
  • ACE-011 and Prednisone

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Complete Response and Partial Response [9 months]

      Complete response is transfusion independence with hemoglobin >9 gm/dl; partial response is transfusion dependence with hemoglobin < 9gm/dl with an increase in reticulocyte count over baseline

    Secondary Outcome Measures

    1. Severe Adverse Events Attributable to Study Drug [9 months]

      Assess severity of adverse events and relationship to sotatercept according to the currently active minor version of the NCI Common Terminology for Adverse Events version 4.0

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • /= 18 years of age

    • DBA diagnosed

    • RBC transfusion- dependence (defined as >/= 10 cc/kg of RBC per 28 days average)

    • Karnofsky performance scale >/= 70

    • Females of childbearing potential are to use birth control during study participation and for 112 days following the last dose of sotatercept

    • Males must agree to use a latex condom during any sexual contact with females of childbearing potential while participating in the study and for 112 days following the last dose of sotatercept

    • Agreement to adhere to the study visit schedule, understand and comply with all protocol requirements

    • Understand and sign a written informed consent

    Exclusion Criteria:

    • Creatinine clearance < 30 ml/min

    • SGOT > 3x upper limit of normal, SGPT > 3x upper limit normal, or bilirubin >3x upper limit normal

    • Heart disease (NY Heart Association classification of >/= 3

    • History of hypertension

    • Subjects currently responsive to corticosteroids for treatment of Diamond Blackfan anemia

    • Treatment with another investigational drug or device <56 days pre-study entry

    • Pregnant or lactating females

    • Cancer

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 North Shore- LIJ campus of The Feinstein Institute for Medical Research Manhasset New York United States 11030

    Sponsors and Collaborators

    • Northwell Health

    Investigators

    • Principal Investigator: Adrianna Vlachos, MD, Northwell Health/Feinstein Institute for Medical Research

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Adrianna Vlachos, Principal Investigator, Northwell Health
    ClinicalTrials.gov Identifier:
    NCT01464164
    Other Study ID Numbers:
    • 11-02-199 - 06A
    First Posted:
    Nov 3, 2011
    Last Update Posted:
    Dec 21, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Keywords provided by Adrianna Vlachos, Principal Investigator, Northwell Health
    Diamond Blackfan anemia
    DBA
    Blackfan Diamond anemia
    Congenital pure red cell aplasia
    Aase-Smith II Syndrome
    Aase Syndrome
    Anemia, Congenital Pure Red Cell
    Aplasia, Congenital Pure Red Cell
    BDA
    Congenital Hypoplastic Anemia
    Erythrogenesis Imperfecta
    Hypoplastic Congenital Anemia
    Inherited Erythroblastopenia
    pure red cell aplasia
    bone marrow failure syndrome
    Additional relevant MeSH terms:
    Anemia
    Anemia, Diamond-Blackfan
    Prednisone

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Sotatercept Cohort 1 Sotatercept Cohort 2 Sotatercept Cohort 3 Sotatercept With Prednisone Boost Cohort 4a Sotatercept Cohort 4b Sotatercept With Prednisone Boost Cohort 5a Sotatercept Cohort 5b
    Arm/Group Description Cohort 1: Sotatercept 0.1 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events Cohort 2: Sotatercept 0.3 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events Cohort 3: Sotatercept 0.5 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events Cohort 4a: Sotatercept 0.75 mg/kg given as a subcutaneous injection every 3 weeks with a three week prednisone boost of 1 mg/kg/day (max 60 mg) - to be completed in 3 patients without untoward events Cohort 4b: Sotatercept 0.75 mg/kg given as a subcutaneous injection every 3 weeks - to be completed in 3 patients without untoward events Cohort 5a: Sotatercept 1 mg/kg as a subcutaneous injection every 3 weeks with a 3 week prednisone boost of 1 mg/kg/day (max 60 mg) to be completed in 3 patients without untoward events Cohort 5b: Sotatercept 1 mg/kg given as a subcutaneous injection every 3 weeks - to be completed in 3 patients without untoward events
    Period Title: Overall Study
    STARTED 3 4 4 2 3 0 3
    COMPLETED 3 3 2 2 3 0 1
    NOT COMPLETED 0 1 2 0 0 0 2

    Baseline Characteristics

    Arm/Group Title Sotatercept Cohort 1 Sotatercept Cohort 2 Sotatercept Cohort 3 Sotatercept With Prednisone Boost Cohort 4a Sotatercept Cohort 4b Sotatercept With Prednisone Boost Cohort 5a Sotatercept Cohort 5b Total
    Arm/Group Description Cohort 1: Sotatercept 0.1 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events Cohort 2: Sotatercept 0.3 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events Cohort 3: Sotatercept 0.5 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events Cohort 4a: Sotatercept 0.75 mg/kg given as a subcutaneous injection every 3 weeks with a three week prednisone boost of 1 mg/kg/day (max 60 mg) - to be completed in 3 patients without untoward events Cohort 4b: Sotatercept 0.75 mg/kg given as a subcutaneous injection every 3 weeks - to be completed in 3 patients without untoward events Cohort 5a: Sotatercept 1 mg/kg as a subcutaneous injection every 3 weeks with a 3 week prednisone boost of 1 mg/kg/day (max 60 mg) to be completed in 3 patients without untoward events Cohort 5b: Sotatercept 1 mg/kg given as a subcutaneous injection every 3 weeks - to be completed in 3 patients without untoward events Total of all reporting groups
    Overall Participants 3 4 4 2 3 0 3 19
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    36
    34
    32
    39
    31
    37
    35
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    3
    75%
    1
    25%
    1
    50%
    1
    33.3%
    0
    NaN
    0
    0%
    6
    31.6%
    Male
    3
    100%
    0
    0%
    1
    25%
    1
    50%
    2
    66.7%
    0
    NaN
    1
    33.3%
    8
    42.1%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    1
    33.3%
    0
    0%
    0
    0%
    0
    0%
    1
    33.3%
    0
    NaN
    1
    33.3%
    3
    15.8%
    Not Hispanic or Latino
    2
    66.7%
    3
    75%
    2
    50%
    2
    100%
    2
    66.7%
    0
    NaN
    0
    0%
    11
    57.9%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    NaN
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    1
    25%
    0
    0%
    0
    0%
    0
    0%
    0
    NaN
    0
    0%
    1
    5.3%
    Asian
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    33.3%
    0
    NaN
    0
    0%
    1
    5.3%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    NaN
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    NaN
    0
    0%
    0
    0%
    White
    3
    100%
    2
    50%
    1
    25%
    2
    100%
    2
    66.7%
    0
    NaN
    3
    100%
    13
    68.4%
    More than one race
    0
    0%
    1
    25%
    3
    75%
    0
    0%
    0
    0%
    0
    NaN
    0
    0%
    4
    21.1%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    NaN
    0
    0%
    0
    0%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants With Complete Response and Partial Response
    Description Complete response is transfusion independence with hemoglobin >9 gm/dl; partial response is transfusion dependence with hemoglobin < 9gm/dl with an increase in reticulocyte count over baseline
    Time Frame 9 months

    Outcome Measure Data

    Analysis Population Description
    Only subjects who completed the trial are analyzed.
    Arm/Group Title Sotatercept Cohort 1 Sotatercept Cohort 2 Sotatercept Cohort 3 Sotatercept With Prednisone Boost Cohort 4a Sotatercept Cohort 4b Sotatercept With Prednisone Boost Cohort 5a Sotatercept Cohort 5b
    Arm/Group Description Cohort 1: Sotatercept 0.1 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events Cohort 2: Sotatercept 0.3 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events Cohort 3: Sotatercept 0.5 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events Cohort 4a: Sotatercept 0.75 mg/kg given as a subcutaneous injection every 3 weeks with a three week prednisone boost of 1 mg/kg/day (max 60 mg) - to be completed in 3 patients without untoward events Cohort 4b: Sotatercept 0.75 mg/kg given as a subcutaneous injection every 3 weeks - to be completed in 3 patients without untoward events Cohort 5a: Sotatercept 1 mg/kg as a subcutaneous injection every 3 weeks with a 3 week prednisone boost of 1 mg/kg/day (max 60 mg) to be completed in 3 patients without untoward events Cohort 5b: Sotatercept 1 mg/kg given as a subcutaneous injection every 3 weeks - to be completed in 3 patients without untoward events
    Measure Participants 3 3 2 2 3 0 1
    Count of Participants [Participants]
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    NaN
    1
    33.3%
    2. Secondary Outcome
    Title Severe Adverse Events Attributable to Study Drug
    Description Assess severity of adverse events and relationship to sotatercept according to the currently active minor version of the NCI Common Terminology for Adverse Events version 4.0
    Time Frame 9 months

    Outcome Measure Data

    Analysis Population Description
    Only subjects who completed the trial are analyzed.
    Arm/Group Title Sotatercept Cohort 1 Sotatercept Cohort 2 Sotatercept Cohort 3 Sotatercept With Prednisone Boost Cohort 4a Sotatercept Cohort 4b Sotatercept With Prednisone Boost Cohort 5a Sotatercept Cohort 5b
    Arm/Group Description Cohort 1: Sotatercept 0.1 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events Cohort 2: Sotatercept 0.3 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events Cohort 3: Sotatercept 0.5 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events Cohort 4a: Sotatercept 0.75 mg/kg given as a subcutaneous injection every 3 weeks with a three week prednisone boost of 1 mg/kg/day (max 60 mg) - to be completed in 3 patients without untoward events Cohort 4b: Sotatercept 0.75 mg/kg given as a subcutaneous injection every 3 weeks - to be completed in 3 patients without untoward events Cohort 5a: Sotatercept 1 mg/kg as a subcutaneous injection every 3 weeks with a 3 week prednisone boost of 1 mg/kg/day (max 60 mg) to be completed in 3 patients without untoward events Cohort 5b: Sotatercept 1 mg/kg given as a subcutaneous injection every 3 weeks - to be completed in 3 patients without untoward events
    Measure Participants 3 3 2 2 3 0 1
    Count of Participants [Participants]
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    NaN
    0
    0%

    Adverse Events

    Time Frame Adverse events were collected for the time the subject was on study, a total of 9 months.
    Adverse Event Reporting Description Cohort 5a had no subjects enrolled.
    Arm/Group Title Sotatercept Cohort 1 Sotatercept Cohort 2 Sotatercept Cohort 3 Sotatercept With Prednisone Boost Cohort 4a Sotatercept Cohort 4b Sotatercept With Prednisone Boost Cohort 5a Sotatercept Cohort 5b
    Arm/Group Description Cohort 1: Sotatercept 0.1 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events Cohort 2: Sotatercept 0.3 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events Cohort 3: Sotatercept 0.5 mg/kg given as a subcutaneous injection once every 4 weeks - to be completed in 3 patients without untoward events Cohort 4a: Sotatercept 0.75 mg/kg given as a subcutaneous injection every 3 weeks with a three week prednisone boost of 1 mg/kg/day (max 60 mg) - to be completed in 3 patients without untoward events Cohort 4b: Sotatercept 0.75 mg/kg given as a subcutaneous injection every 3 weeks - to be completed in 3 patients without untoward events Cohort 5a: Sotatercept 1 mg/kg as a subcutaneous injection every 3 weeks with a 3 week prednisone boost of 1 mg/kg/day (max 60 mg) to be completed in 3 patients without untoward events Cohort 5b: Sotatercept 1 mg/kg given as a subcutaneous injection every 3 weeks - to be completed in 3 patients without untoward events
    All Cause Mortality
    Sotatercept Cohort 1 Sotatercept Cohort 2 Sotatercept Cohort 3 Sotatercept With Prednisone Boost Cohort 4a Sotatercept Cohort 4b Sotatercept With Prednisone Boost Cohort 5a Sotatercept Cohort 5b
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/3 (0%) 0/3 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/0 (NaN) 0/1 (0%)
    Serious Adverse Events
    Sotatercept Cohort 1 Sotatercept Cohort 2 Sotatercept Cohort 3 Sotatercept With Prednisone Boost Cohort 4a Sotatercept Cohort 4b Sotatercept With Prednisone Boost Cohort 5a Sotatercept Cohort 5b
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/3 (0%) 2/3 (66.7%) 0/2 (0%) 0/2 (0%) 1/3 (33.3%) 0/0 (NaN) 0/1 (0%)
    Endocrine disorders
    Hospitalization 0/3 (0%) 0 1/3 (33.3%) 1 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/1 (0%) 0
    Infections and infestations
    Hospitalization 0/3 (0%) 0 1/3 (33.3%) 1 0/2 (0%) 0 0/2 (0%) 0 0/3 (0%) 0 0/0 (NaN) 0 0/1 (0%) 0
    Elevated liver function tests 0/3 (0%) 0 0/3 (0%) 0 0/2 (0%) 0 0/2 (0%) 0 1/3 (33.3%) 1 0/0 (NaN) 0 0/1 (0%) 0
    Other (Not Including Serious) Adverse Events
    Sotatercept Cohort 1 Sotatercept Cohort 2 Sotatercept Cohort 3 Sotatercept With Prednisone Boost Cohort 4a Sotatercept Cohort 4b Sotatercept With Prednisone Boost Cohort 5a Sotatercept Cohort 5b
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/3 (0%) 0/3 (0%) 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/0 (NaN) 0/1 (0%)

    Limitations/Caveats

    Early termination leading to small numbers of subjects analyzed.

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Adrianna Vlachos, MD
    Organization Feinstein Institutes for Medical Research
    Phone 516-562-1506
    Email avlachos@northwell.edu
    Responsible Party:
    Adrianna Vlachos, Principal Investigator, Northwell Health
    ClinicalTrials.gov Identifier:
    NCT01464164
    Other Study ID Numbers:
    • 11-02-199 - 06A
    First Posted:
    Nov 3, 2011
    Last Update Posted:
    Dec 21, 2021
    Last Verified:
    Nov 1, 2021