Synergistic Pharmacologic Intervention for Prevention of ROP (SPIPROP Study)

Sponsor
State University of New York - Downstate Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02344225
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH), Food and Drug Administration (FDA) (U.S. Fed)
14
1
3
41.9
0.3

Study Details

Study Description

Brief Summary

Phase 2, open-label, randomized, multi-center studies in infants and premature infants are necessary to determine treatment and preventative strategies for ROP. This study was designed to: a) target infants at the highest risk of ROP in a large number of centers with variable rates of ROP (all stages and severe ROP or stage 3+); and b) assess whether caffeine plus systemic or ophthalmic NSAID will decrease ROP among infants most at risk for ROP. The study is designed to determine whether the novel treatment regimens are safe and potentially effective for ROP prevention and to obtain requisite data for the development of a Phase III efficacy/safety randomized blinded trial. Since caffeine is used extensively in NICUs as standard of care for ELGANs, no placebo group is included.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

This study will evaluate the safety, tolerability and PK-PD of, and to compare and contrast, IV Ibuprofen with Caffeine and Ketorolac eye drops with Caffeine in ELGAN infants <28 weeks GA for 14 days duration to treat and preferably prevent ROP associated with prematurity and

ELGAN. The specific aims of this trial are:

Aim 1: To establish the synergistic effect of local ophthalmic NSIADs and systemic caffeine as optimal therapies for the attenuation and/or prevention of severe ROP. Hypothesis: Ocular Ketorolac or systemic Ibuprofen potentiated with systemic Caffeine will prevent or diminish the severity of ROP. We will: a) Evaluate the safety, tolerability, and efficacy of early postnatal local ophthalmic NSIADs for prevention of severe ROP in ELGANs. b) Determine the pharmacokinetics, pharmacodymanics and pharmacogenomics of NSAIDs potentiated with caffeine for prevention of ROP.

Aim 2: To identify a "critical" number of arterial oxygen desaturations as a key risk factor for severe ROP.

Hypothesis: A "critical" number of daily arterial oxygen desaturations during the first two weeks of life is a key risk factor for severe ROP. We will: a) Further define the role of VEGF, IGF, MMPs, and ROS in ROP and correlate the levels with the number of arterial oxygen desaturations. b) Establish and identify whether increased serum VEGF in infants with severe ROP is the diffusible isoform VEGF121. This isoform is formed from VEGF proteolysis by plasmin and MMPs. MMPs also cleave Notch/Dll4, which acts as a regulator of VEGF signaling.

Aim 3: To determine whether infants at risk for severe ROP are haploinsufficient for the delta-like ligand 4 (Dll4).

Hypothesis: ELGANs at risk for severe ROP will have different pattern of gene expression specifically related to the Notch signaling pathway, as has been previously shown in animal models. We will: a) Examine cord blood, cord tissue, and placental tissue to compare the gene profile of VEGF and Notch signaling pathways among infants who develop severe ROP and those who do not; and b) Determine whether NSAIDs and/or Caffeine will confer protective benefits on Notch/Dll4 signaling and prevent the development of severe ROP.

This is a phase 2b, randomized, open label, multi-center, safety, tolerability and efficacy study comparing 3 interventions for possible prevention of ROP. The trial will be conducted in at least 8 investigational sites including the Neonatal networks (SUNY Downstate and the Brooklyn-Queens Neonatal Network sites, SUNY Stony Brook), and Miller Children's Hospital, Long Beach, CA. An independent DSMB will assess safety during the study. This study will monitor for safety while on study drug and for 7 days after last dose of drug. An exploratory study to determine the role of pharmacodynamic, drug concentrations (as surrogate of PK profile) and pharmacogenomics will also be conducted in this patient population.

One hundred and twenty preterm infants (<28 weeks gestation; <1250 grams) between 0 and 72 hours of life will be randomized to receive either:

  1. Caffeine citrate IV (20 mg/kg loading dose followed by 5 mg/kg/day maintenance dose) plus placebo saline IV (1 ml/kg followed by 0.25 ml/kg) for 5 days plus sterile normal saline (one drop two times a day) for 14 days (n=40);

  2. Caffeine citrate as described in group 1 plus Ibuprofen (10 mg/kg loading dose followed by low dose ibuprofen 2.5 mg/kg/day) for 5 days plus sterile normal saline (one drop two times a day) for 14 days (n=40); and

  3. Caffeine citrate plus saline IV placebo as described in group 1, and Ketorolac (Acuvail) eye drops (one drop two times a day) for 14 days (n=40)

Study Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Synergistic Pharmacologic Intervention for Prevention of ROP (SPIPROP STUDY)
Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Jun 30, 2018
Actual Study Completion Date :
Jun 30, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Caffeine+Saline IV+Saline drops

Caffeine citrate IV (20 mg/kg loading dose, 5 mg/kg/day maintenance dose) plus placebo saline IV (1 ml/kg followed by 0.25 ml/kg) for 5 days plus sterile normal saline (one drop two times a day) for 14 days (n=40); Caffeine is the intervention

Drug: Caffeine citrate
Caffeine citrate IV (20 mg/kg loading dose, 5 mg/kg/day maintenance dose)
Other Names:
  • Caffeine
  • Experimental: Caffeine+Ibp IV+Saline drops

    Caffeine citrate as described in group 1, plus Ibuprofen (10 mg/kg loading dose followed by low dose ibuprofen 2.5 mg/kg/day) for 5 days plus sterile normal saline (one drop two times a day) for 14 days (n=40); Ibuprofen is the intervention

    Drug: Ibuprofen
    Ibuprofen (10 mg/kg loading dose followed by low dose ibuprofen 2.5 mg/kg/day) for 5 days
    Other Names:
  • Neoprofen
  • Experimental: Caffeine+Saline+Ketorolac drops

    Caffeine citrate plus saline IV placebo as described in group 1, and Ketorolac (Acuvail) eye drops (one drop two times a day) for 14 days (n=40); Ketorolac is the intervention

    Drug: Ketorolac
    Ketorolac (Acuvail) eye drops (one drop two times a day) for 14 days
    Other Names:
  • Acuvail
  • Outcome Measures

    Primary Outcome Measures

    1. Efficacy as Measured by the Number of Participants Presenting With Retinopathy of Prematurity (ROP) and the Rate of Stages/Grade of ROP. [50 weeks PCA +/- 7 days]

      ROP (all grades) will be graded using International ROP Classification and severe ROP (Stage 3+ disease) or need for laser or Avastin The rate of mild (stage 1), moderate (stage 2) and severe ROP (stages >3) will be calculated as the number of infants diagnosed with ROP over the number of infants receiving retinal examinations. The study enrolled only 14 of the projected sample of 120, and the low enrollment did not allow meaningful analyses of efficacy and safety.

    Secondary Outcome Measures

    1. Number of Participants With Adverse Events as a Measure of Safety and Tolerability [Eye examinations was done at standard of care through discharge and once, at 50 weeks PCA. All infants underwent routine eye examination by a pediatric ophthalmologist according to the International Classification for ROP]

      We did not reach the target number of participants needed to measure statistically reliable outcome measure. The secondary outcome measure included Intraventricular hemorrhage (Papile's criteria) and ocular examination for corneal lesions.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 28 Weeks
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Neonates at high risk for ROP as outlined by the American Academy of Pediatrics, Section on Ophthalmology; American Association for Pediatric Ophthalmology and Strabismus; and American Academy of Ophthalmology (129) will be enrolled. Inclusion criteria are:
    1. all infants with a birth weight of less than 1250 grams;

    2. all infants with a gestational age of 28 weeks or less; and

    3. all infants who required oxygen therapy and ventilator support within the first 2 days of life.

    Exclusion Criteria:
    • Exclusion criteria are:
    1. major congenital malformations and or chromosomal anomalies including duct-dependent cardiac anomalies;

    2. maternal antenatal NSAID exposure <72 hours before birth;

    3. renal failure or oliguria defined as a urine flow rate <0.5 mL/kg/hour in the 8 hours prior to randomization. Anuria is acceptable if infant is less than 24 hours of life;

    4. platelet count <75,000.mm3;

    5. clinical bleeding such as oozing from puncture sites; and

    6. participation in other clinical drug trials while subject participates in this study and for 7 days after last dose of study drug.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 SUNY Downstate Medical Center/University Hospital of Brooklyn Brooklyn New York United States 11203

    Sponsors and Collaborators

    • State University of New York - Downstate Medical Center
    • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
    • Food and Drug Administration (FDA)

    Investigators

    • Principal Investigator: Jacob V Aranda, MD, PhD, SUNY Downstate Medical Center, University Hospital of Brooklyn

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Khadija Sikriti, Clinical Trials Project Manager, State University of New York - Downstate Medical Center
    ClinicalTrials.gov Identifier:
    NCT02344225
    Other Study ID Numbers:
    • 349622
    • 1U54HD071594
    First Posted:
    Jan 22, 2015
    Last Update Posted:
    May 1, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details The study started on Jan 01, 2015, and ended on Jun 30, 2018. Ninety-Eight (98) participants have been screened at five study sites. However, only 14 participants were enrolled. The reasons for poor enrollment were mostly due to refusal to participate, and some did not meet the eligibility criteria. All participants completed the study.
    Pre-assignment Detail The study screened 98 subjects when most mothers were admitted for preterm labor. They were treated successfully with tocolysis and other clinical managements (e.g. bed rest, magnesium sulfate etc.) which resulted in prolonging the pregnancy beyond 28 weeks at which time they met exclusion criteria and no longer eligible for the study..
    Arm/Group Title Caffeine+Saline IV+Saline Drops Caffeine+Ibp IV+Saline Drops Caffeine+Saline+Ketorolac Drops
    Arm/Group Description Caffeine citrate IV (20 mg/kg loading dose, 5 mg/kg/day maintenance dose) plus placebo saline IV (1 ml/kg followed by 0.25 ml/kg) for 5 days plus sterile normal saline (one drop two times a day) for 14 days (n=40); Caffeine is the intervention Caffeine citrate: Caffeine citrate IV (20 mg/kg loading dose, 5 mg/kg/day maintenance dose) Caffeine citrate as described in group 1, plus Ibuprofen (10 mg/kg loading dose followed by low dose ibuprofen 2.5 mg/kg/day) for 5 days plus sterile normal saline (one drop two times a day) for 14 days (n=40); Ibuprofen is the intervention Ibuprofen: Ibuprofen (10 mg/kg loading dose followed by low dose ibuprofen 2.5 mg/kg/day) for 5 days Caffeine citrate plus saline IV placebo as described in group 1, and Ketorolac (Acuvail) eye drops (one drop two times a day) for 14 days (n=40); Ketorolac is the intervention Ketorolac: Ketorolac (Acuvail) eye drops (one drop two times a day) for 14 days
    Period Title: Overall Study
    STARTED 6 3 5
    COMPLETED 6 3 5
    NOT COMPLETED 0 0 0

    Baseline Characteristics

    Arm/Group Title Caffeine+Saline IV+Saline Drops Caffeine+Ibp IV+Saline Drops Caffeine+Saline+Ketorolac Drops Total
    Arm/Group Description Caffeine citrate IV (20 mg/kg loading dose, 5 mg/kg/day maintenance dose) plus placebo saline IV (1 ml/kg followed by 0.25 ml/kg) for 5 days plus sterile normal saline (one drop two times a day) for 14 days (n=40); Caffeine is the intervention Caffeine citrate: Caffeine citrate IV (20 mg/kg loading dose, 5 mg/kg/day maintenance dose) Caffeine citrate as described in group 1, plus Ibuprofen (10 mg/kg loading dose followed by low dose ibuprofen 2.5 mg/kg/day) for 5 days plus sterile normal saline (one drop two times a day) for 14 days (n=40); Ibuprofen is the intervention Ibuprofen: Ibuprofen (10 mg/kg loading dose followed by low dose ibuprofen 2.5 mg/kg/day) for 5 days Caffeine citrate plus saline IV placebo as described in group 1, and Ketorolac (Acuvail) eye drops (one drop two times a day) for 14 days (n=40); Ketorolac is the intervention Ketorolac: Ketorolac (Acuvail) eye drops (one drop two times a day) for 14 days Total of all reporting groups
    Overall Participants 6 3 5 14
    Age (Gestational Age in Week) [Mean (Full Range) ]
    Mean (Full Range) [Gestational Age in Week]
    25.5
    26.7
    26.6
    26.6
    Sex: Female, Male (Count of Participants)
    Female
    2
    33.3%
    2
    66.7%
    3
    60%
    7
    50%
    Male
    4
    66.7%
    1
    33.3%
    2
    40%
    7
    50%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    3
    50%
    3
    100%
    2
    40%
    8
    57.1%
    Not Hispanic or Latino
    3
    50%
    0
    0%
    3
    60%
    6
    42.9%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    2
    33.3%
    0
    0%
    0
    0%
    2
    14.3%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    1
    16.7%
    0
    0%
    3
    60%
    4
    28.6%
    White
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    3
    50%
    3
    100%
    2
    40%
    8
    57.1%
    Birth Weight (grams) (Grams) [Mean (Full Range) ]
    Mean (Full Range) [Grams]
    731.7
    1119.3
    1020
    917.7

    Outcome Measures

    1. Primary Outcome
    Title Efficacy as Measured by the Number of Participants Presenting With Retinopathy of Prematurity (ROP) and the Rate of Stages/Grade of ROP.
    Description ROP (all grades) will be graded using International ROP Classification and severe ROP (Stage 3+ disease) or need for laser or Avastin The rate of mild (stage 1), moderate (stage 2) and severe ROP (stages >3) will be calculated as the number of infants diagnosed with ROP over the number of infants receiving retinal examinations. The study enrolled only 14 of the projected sample of 120, and the low enrollment did not allow meaningful analyses of efficacy and safety.
    Time Frame 50 weeks PCA +/- 7 days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Caffeine+Saline IV+Saline Drops Caffeine+Ibp IV+Saline Drops Caffeine+Saline+Ketorolac Drops
    Arm/Group Description Caffeine citrate IV (20 mg/kg loading dose, 5 mg/kg/day maintenance dose) plus placebo saline IV (1 ml/kg followed by 0.25 ml/kg) for 5 days plus sterile normal saline (one drop two times a day) for 14 days (n=40); Caffeine is the intervention Caffeine citrate: Caffeine citrate IV (20 mg/kg loading dose, 5 mg/kg/day maintenance dose) Caffeine citrate as described in group 1, plus Ibuprofen (10 mg/kg loading dose followed by low dose ibuprofen 2.5 mg/kg/day) for 5 days plus sterile normal saline (one drop two times a day) for 14 days (n=40); Ibuprofen is the intervention Ibuprofen: Ibuprofen (10 mg/kg loading dose followed by low dose ibuprofen 2.5 mg/kg/day) for 5 days Caffeine citrate plus saline IV placebo as described in group 1, and Ketorolac (Acuvail) eye drops (one drop two times a day) for 14 days (n=40); Ketorolac is the intervention Ketorolac: Ketorolac (Acuvail) eye drops (one drop two times a day) for 14 days
    Measure Participants 6 3 5
    No ROP
    5
    83.3%
    3
    100%
    4
    80%
    Mild ROP (Stage 1)
    1
    16.7%
    0
    0%
    0
    0%
    Moderate ROP (Stage2)
    0
    0%
    0
    0%
    1
    20%
    severe ROP (stages >3)
    0
    0%
    0
    0%
    0
    0%
    2. Secondary Outcome
    Title Number of Participants With Adverse Events as a Measure of Safety and Tolerability
    Description We did not reach the target number of participants needed to measure statistically reliable outcome measure. The secondary outcome measure included Intraventricular hemorrhage (Papile's criteria) and ocular examination for corneal lesions.
    Time Frame Eye examinations was done at standard of care through discharge and once, at 50 weeks PCA. All infants underwent routine eye examination by a pediatric ophthalmologist according to the International Classification for ROP

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Caffeine+Saline IV+Saline Drops Caffeine+Ibp IV+Saline Drops Caffeine+Saline+Ketorolac Drops
    Arm/Group Description Caffeine citrate IV (20 mg/kg loading dose, 5 mg/kg/day maintenance dose) plus placebo saline IV (1 ml/kg followed by 0.25 ml/kg) for 5 days plus sterile normal saline (one drop two times a day) for 14 days (n=40); Caffeine is the intervention Caffeine citrate: Caffeine citrate IV (20 mg/kg loading dose, 5 mg/kg/day maintenance dose) Caffeine citrate as described in group 1, plus Ibuprofen (10 mg/kg loading dose followed by low dose ibuprofen 2.5 mg/kg/day) for 5 days plus sterile normal saline (one drop two times a day) for 14 days (n=40); Ibuprofen is the intervention Ibuprofen: Ibuprofen (10 mg/kg loading dose followed by low dose ibuprofen 2.5 mg/kg/day) for 5 days Caffeine citrate plus saline IV placebo as described in group 1, and Ketorolac (Acuvail) eye drops (one drop two times a day) for 14 days (n=40); Ketorolac is the intervention Ketorolac: Ketorolac (Acuvail) eye drops (one drop two times a day) for 14 days
    Measure Participants 6 3 5
    Count of Participants [Participants]
    0
    0%
    0
    0%
    1
    20%
    3. Post-Hoc Outcome
    Title Length of Hospital Stay
    Description Safety as measured by Length of hospital stay
    Time Frame on average 6 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Caffeine+Saline IV+Saline Drops Caffeine+Ibp IV+Saline Drops Caffeine+Saline+Ketorolac Drops
    Arm/Group Description Caffeine citrate IV (20 mg/kg loading dose, 5 mg/kg/day maintenance dose) plus placebo saline IV (1 ml/kg followed by 0.25 ml/kg) for 5 days plus sterile normal saline (one drop two times a day) for 14 days (n=40); Caffeine is the intervention Caffeine citrate: Caffeine citrate IV (20 mg/kg loading dose, 5 mg/kg/day maintenance dose) Caffeine citrate as described in group 1, plus Ibuprofen (10 mg/kg loading dose followed by low dose ibuprofen 2.5 mg/kg/day) for 5 days plus sterile normal saline (one drop two times a day) for 14 days (n=40); Ibuprofen is the intervention Ibuprofen: Ibuprofen (10 mg/kg loading dose followed by low dose ibuprofen 2.5 mg/kg/day) for 5 days Caffeine citrate plus saline IV placebo as described in group 1, and Ketorolac (Acuvail) eye drops (one drop two times a day) for 14 days (n=40); Ketorolac is the intervention Ketorolac: Ketorolac (Acuvail) eye drops (one drop two times a day) for 14 days
    Measure Participants 6 3 5
    Mean (Standard Deviation) [Days]
    126
    (30.1)
    74
    (9.0)
    68
    (21.8)

    Adverse Events

    Time Frame The adverse events data were collected over an average of 6 months.
    Adverse Event Reporting Description
    Arm/Group Title Caffeine+Saline IV+Saline Drops Caffeine+Ibp IV+Saline Drops Caffeine+Saline+Ketorolac Drops
    Arm/Group Description Caffeine citrate IV (20 mg/kg loading dose, 5 mg/kg/day maintenance dose) plus placebo saline IV (1 ml/kg followed by 0.25 ml/kg) for 5 days plus sterile normal saline (one drop two times a day) for 14 days (n=40); Caffeine is the intervention Caffeine citrate: Caffeine citrate IV (20 mg/kg loading dose, 5 mg/kg/day maintenance dose) Caffeine citrate as described in group 1, plus Ibuprofen (10 mg/kg loading dose followed by low dose ibuprofen 2.5 mg/kg/day) for 5 days plus sterile normal saline (one drop two times a day) for 14 days (n=40); Ibuprofen is the intervention Ibuprofen: Ibuprofen (10 mg/kg loading dose followed by low dose ibuprofen 2.5 mg/kg/day) for 5 days Caffeine citrate plus saline IV placebo as described in group 1, and Ketorolac (Acuvail) eye drops (one drop two times a day) for 14 days (n=40); Ketorolac is the intervention Ketorolac: Ketorolac (Acuvail) eye drops (one drop two times a day) for 14 days
    All Cause Mortality
    Caffeine+Saline IV+Saline Drops Caffeine+Ibp IV+Saline Drops Caffeine+Saline+Ketorolac Drops
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/6 (0%) 0/3 (0%) 2/5 (40%)
    Serious Adverse Events
    Caffeine+Saline IV+Saline Drops Caffeine+Ibp IV+Saline Drops Caffeine+Saline+Ketorolac Drops
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 6/6 (100%) 3/3 (100%) 2/5 (40%)
    Congenital, familial and genetic disorders
    Patent ductus arteriosus (PDA) 2/6 (33.3%) 1/3 (33.3%) 0/5 (0%)
    Gastrointestinal disorders
    Death 0/6 (0%) 0 0/3 (0%) 0 2/5 (40%) 2
    Necrotizing enterocolitis (NEC) 0/6 (0%) 0/3 (0%) 2/5 (40%)
    Nervous system disorders
    Intraventricular hemorrhage (IVH) 0/6 (0%) 0/3 (0%) 1/5 (20%)
    Respiratory, thoracic and mediastinal disorders
    Apnea 6/6 (100%) 3/3 (100%) 2/5 (40%)
    Bronchopulmonary dysplasia (BPD 1/6 (16.7%) 0/3 (0%) 2/5 (40%)
    Other (Not Including Serious) Adverse Events
    Caffeine+Saline IV+Saline Drops Caffeine+Ibp IV+Saline Drops Caffeine+Saline+Ketorolac Drops
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 6/6 (100%) 3/3 (100%) 5/5 (100%)
    Respiratory, thoracic and mediastinal disorders
    Respiratory Distress Syndrome (RDS) 6/6 (100%) 3/3 (100%) 5/5 (100%)

    Limitations/Caveats

    We did not reach the target number of participants needed to achieve target power and statistically reliable results. Slow enrollment also causes delayed reporting.

    More Information

    Certain Agreements

    Principal Investigators are NOT 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 Jacob V. Aranda, MD, PhD, FRCPC, Principal Investigator
    Organization SUNY Downstate Medical Center
    Phone 718-270-1912
    Email jaranda@downstate.edu
    Responsible Party:
    Khadija Sikriti, Clinical Trials Project Manager, State University of New York - Downstate Medical Center
    ClinicalTrials.gov Identifier:
    NCT02344225
    Other Study ID Numbers:
    • 349622
    • 1U54HD071594
    First Posted:
    Jan 22, 2015
    Last Update Posted:
    May 1, 2020
    Last Verified:
    Apr 1, 2020