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CompletedNCT01691794Updated Apr 27, 2018Results posted

Safety Sudy of Atazanavir Boosted With Ritonavir in the Treatment of HIV Infection in Pediatric Patients

A Phase 4 interventional study of Atazanavir and Ritonavir in HIV, Pediatric, sponsored by Bristol-Myers Squibb. Completed at 27 sites in 8 countries. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2018-04-27.

Sponsored by Bristol-Myers Squibb · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
108
Allocation
Non-randomized
Ages
6 Years to 17 Years
Sex
All
01

Study summary

The purpose of this study is to collect safety clinical data in HIV-infected pediatric patients aged 6 and older to younger than18 years and weighing 15 kg or more, who are receiving atazanavir capsule boosted with ritonavir and an optimized nucleoside reverse transcriptase inhibitor backbone therapy as part of their antiretroviral regimen.

02

Conditions studied

  • HIV, Pediatric
03

In context

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Confirmed HIV-1 infection diagnosed by protocol criteria
  • Male or female children, ≥ 6 years to \<17 years 6 months of age at the time of first treatment
  • Antiretroviral-naïve or treatment-experienced participants with a detectable viral load
  • Antiretroviral-naïve participants must have genotypic sensitivity at screening to atazanavir and at least 2 nucleoside reverse transcriptase inhibitors (NRTIs), which have been approved for pediatric use and dosed per local country label
  • Antiretroviral-experienced participants must have documented genotypic and phenotypic sensitivity at screening to atazanavir (fold change in susceptibility \<2.2) and at least 2 NRTIs, which have been approved for pediatric use and dosed per local country label.

Exclusion criteria

Exclusion Criteria:

  • Experienced participants who received atazanavir with or without ritonavir at any time prior to study enrollment
  • Antiretroviral-naive or -experienced HIV-1 infected patients with contraindication to study medications
  • Documented cardiac conduction abnormality, significant cardiac dysfunction, or a history syncope
  • Family history of QTc interval syndrome, Brugada syndrome, right ventricular dysplasia, or a corrected QTc interval of >440 ms at screening

  • One of the following cardiac rhythm abnormalities documented on the screening electrocardiogram:

    1. First degree atrioventricular (AV) block, as defined by protocol
    2. Type I second degree AV block while awake, type II second degree AV block at any time, complete AV block at any time, or age-adjusted heart rate \<2nd percentile
  • Coinfection with either hepatitis B or C virus
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
108 participants (actual)

Study arms

  • Active comparator
    Atazanavir, 150 mg + Ritonavir, 100 mg (weight:15 to <20 kg)

    Participants with baseline weight of 15 to \<20 kg received 150 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.

    Drug: Atazanavir · Drug: Ritonavir

  • Active comparator
    Atazanavir, 200 mg + Ritonavir, 100 mg (weight: 20 to <40 kg)

    Participants with baseline weight of 20 to \<40 kg received 200 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.

    Drug: Atazanavir · Drug: Ritonavir

  • Active comparator
    Atazanavir, 300 mg + Ritonavir, 100 mg (weight: ≥ 40 kg)

    Participants with baseline weight ≥ 40 kg received 300 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.

    Drug: Atazanavir · Drug: Ritonavir

Interventions

  • DrugAtazanavir

    Also known as: Reyataz, BMS-232632

  • DrugRitonavir

    Also known as: Norvir

06

What researchers measure

Primary outcomes

  1. Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, Grade 2-4 Related AEs, Grade 3-4 AEs, and Centers for Disease Control (CDC) Class C AIDS Events

    AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death.

    Time frame: From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)

  2. Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4

    Hematocrit (%): Grade (Gr) 1= ≥28.5- \<31.5; Gr 2= ≥24- \<28.5; Gr 3= ≥19.5- \<24; Gr 4= \<19.5. Hemoglobin (g/dL): Grade (Gr)1=8.5-10.0; Gr 2=7.5-8.4; Gr 3=6.50-7.4; Gr 4= \<6.5. Platelets (/mm\^3): Gr 1=100,000-124,999; Gr 2=50,000-99,999; Gr 3=25,000-49,999; Gr 4= \<25,000. White blood cells (/mm\^3): Gr 1=2000-2500; Gr 2=1500-1999; Gr 3=1000-1499; Gr 4= \<1000. Neutrophils (/mm\^3): Gr 1=1000-1500; Gr 2= ≥750-1000; Gr 3= ≥500-750; Gr 4= \<500. Alanine transaminase (ALT), alkaline phosphatase (ALP), aspartate transaminase (AST) (\*upper limit of normal \[ULN\]): Gr 1=1.5-2.5; Gr 2=2.6-5.0; Gr 3=5.1-10.0; Gr 4= \>10.0. Total bilirubin (adult and pediatric \>14 days) (\*ULN): Gr 1=1.1-1.5; Gr 2=1.6-2.5; Gr 3=2.6-5.0; Gr 4= \>5.0. Albumin (g/dL): Gr 1= 3.1- \<LLN; Gr 2=2.0-2.9; Gr 3= \<2.0; Gr 4=NA. Amylase (\*ULN): Gr 1=1.10-1.39; Gr 2=1.40-2.09; Gr 3=2.10-5.0; Gr 4= \>5. Lipase (\*ULN): Gr 1=1.1-1.5; Gr 2=1.6-3.0; Gr 3=3.1-5.0; Gr 4= \>5.0.

    Time frame: After first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)

  3. Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued)

    Blood urea nitrogen (\*upper limit of normal \[ULN\]): Grade (Gr) 1=1.25-2.5; Gr 2=2.6-5.0; Gr 3=5.1-10; Gr 4= \>10. Uric acid (mg/dL): Gr 1=7.5-10.0; Gr 2=10.1-12; Gr 3=12.1-15.0; Gr 4= \>15.0. Bicarbonate (mEqL): Gr 1= 19.0-21.0; Gr 2=15.0-18.0; Gr 3=41-45; Gr 4= \>45. Calcium, low (mg/dL): Gr 1=7.8-8.4; Gr 2=7.0-7.7; Gr 3=6.1-6.9; Gr 4= \<6.1.Potassium (mEq/L), high: Gr 1=5.6-6.0; Gr 2=6.1-6.5; Gr 3=6.6-7.0; Gr 4= \>7.0. Potassium (mEq/L), low: Gr 1=3.1-3.4; Gr 2=2.5-2.9; Gr 3=2.0-2.4; Gr 4= \<2.0. Sodium (mEq/L), low: Gr 1=130-135; Gr 2=125-129; Gr 3=121-124; Gr 4= \<1. Total cholesterol, fasting (mg/dL): Gr 1=200-239; Gr 2=240-300; Gr 3= \>300; Gr 4=Not applicable (NA). Low-density lipoprotein (LDL) cholesterol, fasting (mg/dL): Gr 1=130-159; Gr 2=160-190; Gr 3= \>190; Gr 4= NA. Glucose, low (mg/dL): Gr 1= 55-64; Gr 2=40-54; Gr 3=30-39; Gr 4= \<30. Glucose, fasting (mg/dL): Gr 1=110-125; Gr 2=126-250; Gr 3=251-500; Gr 4 \>500.

    Time frame: After first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)

07

Results

Posted Nov 30, 2015

Participant flow

Participant flow — Overall Study
MilestoneAtazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg)
Started33323
Completed21513
Not completed11810
Withdrew: Poor/non-compliance141
Withdrew: Death001
Withdrew: Lack of efficacy071
Withdrew: Participant request to discontinue010
Withdrew: Adverse event011
Withdrew: Completed only first 24 weeks of study023
Withdrew: Did not complete first 24 weeks of study033

Outcome measures

PrimaryNumber of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, Grade 2-4 Related AEs, Grade 3-4 AEs, and Centers for Disease Control (CDC) Class C AIDS Events

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death.

Time frame:
From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Reported as:
Number · Participants
Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, Grade 2-4 Related AEs, Grade 3-4 AEs, and Centers for Disease Control (CDC) Class C AIDS Events
ParticipantsAtazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg)
Deaths001
SAEs134
AEs leading to discontinuation012
Grade 2-4 related AEs135
Grade 3-4 AEs035
CDC Class C AIDS events010
PrimaryNumber of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4

Hematocrit (%): Grade (Gr) 1= ≥28.5- \<31.5; Gr 2= ≥24- \<28.5; Gr 3= ≥19.5- \<24; Gr 4= \<19.5. Hemoglobin (g/dL): Grade (Gr)1=8.5-10.0; Gr 2=7.5-8.4; Gr 3=6.50-7.4; Gr 4= \<6.5. Platelets (/mm\^3): Gr 1=100,000-124,999; Gr 2=50,000-99,999; Gr 3=25,000-49,999; Gr 4= \<25,000. White blood cells (/mm\^3): Gr 1=2000-2500; Gr 2=1500-1999; Gr 3=1000-1499; Gr 4= \<1000. Neutrophils (/mm\^3): Gr 1=1000-1500; Gr 2= ≥750-1000; Gr 3= ≥500-750; Gr 4= \<500. Alanine transaminase (ALT), alkaline phosphatase (ALP), aspartate transaminase (AST) (\*upper limit of normal \[ULN\]): Gr 1=1.5-2.5; Gr 2=2.6-5.0; Gr 3=5.1-10.0; Gr 4= \>10.0. Total bilirubin (adult and pediatric \>14 days) (\*ULN): Gr 1=1.1-1.5; Gr 2=1.6-2.5; Gr 3=2.6-5.0; Gr 4= \>5.0. Albumin (g/dL): Gr 1= 3.1- \<LLN; Gr 2=2.0-2.9; Gr 3= \<2.0; Gr 4=NA. Amylase (\*ULN): Gr 1=1.10-1.39; Gr 2=1.40-2.09; Gr 3=2.10-5.0; Gr 4= \>5. Lipase (\*ULN): Gr 1=1.1-1.5; Gr 2=1.6-3.0; Gr 3=3.1-5.0; Gr 4= \>5.0.

Time frame:
After first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Reported as:
Number · Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4
ParticipantsAtazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg)
Hematocrit030
Hemoglobin050
Platelets001
White blood cells030
Neutrophils+bands (absolute)1134
ALT169
AST065
ALP11112
Total bilirubin32617
Albumin2156
Amylase22714
Lipase0158
PrimaryNumber of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued)

Blood urea nitrogen (\*upper limit of normal \[ULN\]): Grade (Gr) 1=1.25-2.5; Gr 2=2.6-5.0; Gr 3=5.1-10; Gr 4= \>10. Uric acid (mg/dL): Gr 1=7.5-10.0; Gr 2=10.1-12; Gr 3=12.1-15.0; Gr 4= \>15.0. Bicarbonate (mEqL): Gr 1= 19.0-21.0; Gr 2=15.0-18.0; Gr 3=41-45; Gr 4= \>45. Calcium, low (mg/dL): Gr 1=7.8-8.4; Gr 2=7.0-7.7; Gr 3=6.1-6.9; Gr 4= \<6.1.Potassium (mEq/L), high: Gr 1=5.6-6.0; Gr 2=6.1-6.5; Gr 3=6.6-7.0; Gr 4= \>7.0. Potassium (mEq/L), low: Gr 1=3.1-3.4; Gr 2=2.5-2.9; Gr 3=2.0-2.4; Gr 4= \<2.0. Sodium (mEq/L), low: Gr 1=130-135; Gr 2=125-129; Gr 3=121-124; Gr 4= \<1. Total cholesterol, fasting (mg/dL): Gr 1=200-239; Gr 2=240-300; Gr 3= \>300; Gr 4=Not applicable (NA). Low-density lipoprotein (LDL) cholesterol, fasting (mg/dL): Gr 1=130-159; Gr 2=160-190; Gr 3= \>190; Gr 4= NA. Glucose, low (mg/dL): Gr 1= 55-64; Gr 2=40-54; Gr 3=30-39; Gr 4= \<30. Glucose, fasting (mg/dL): Gr 1=110-125; Gr 2=126-250; Gr 3=251-500; Gr 4 \>500.

Time frame:
After first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)
Reported as:
Number · Participants
Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued)
ParticipantsAtazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg)
Blood urea nitrogen030
Uric acid023
Bicarbonate, low32917
Calcium, low023
Potassium, high021
Potassium, low020
Total cholesterol, fasting (n=3, 31, 21)0106
Sodium, low1130
LDL cholesterol, fasting (n=3, 31, 21)073
Glucose, low (n=1, 11, 9)030
Glucose, fasting, high (3, 31, 22)031
Calcium, high020
Chloride, high002
Chloride, low000
Glucose, Non-Fasting, High000
Sodium, high011
Creatinine010
Triglycerides, fasting000

Adverse events

Collected over From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
B/L Weight 15 to Less Than 20 kg0/3 (0%)1/3 (33.3%)3/3 (100%)
B/L Weight 20 to Less Than 40 kg0/33 (0%)3/33 (9.1%)26/33 (78.8%)
B/L Weight Greater Than and Equal 40 kg1/23 (4.3%)4/23 (17.4%)20/23 (87%)
Most frequent serious events
Most frequent serious events
EventB/L Weight 15 to Less Than 20 kgB/L Weight 20 to Less Than 40 kgB/L Weight Greater Than and Equal 40 kg
Accidental overdoseInjury, poisoning and procedural complications1/30/330/23
Abdominal painGastrointestinal disorders0/30/331/23
AppendicitisInfections and infestations0/30/331/23
Meningitis bacterialInfections and infestations0/30/331/23
Abnormal behaviourPsychiatric disorders0/30/331/23
OverdoseInjury, poisoning and procedural complications0/31/330/23
SeizureNervous system disorders0/31/330/23
GlomerulonephritisRenal and urinary disorders0/31/330/23
HaematuriaRenal and urinary disorders0/31/330/23
Post streptococcal glomerulonephritisRenal and urinary disorders0/31/330/23
Most frequent other events
Showing 10 of 40
Most frequent other events
EventB/L Weight 15 to Less Than 20 kgB/L Weight 20 to Less Than 40 kgB/L Weight Greater Than and Equal 40 kg
Upper respiratory tract infectionInfections and infestations2/313/334/23
JaundiceHepatobiliary disorders1/32/336/23
BronchitisInfections and infestations1/32/330/23
GastroenteritisInfections and infestations1/33/330/23
InfluenzaInfections and infestations1/33/333/23
NasopharyngitisInfections and infestations1/33/336/23
Otitis mediaInfections and infestations1/32/332/23
TonsillitisInfections and infestations1/34/330/23
PharyngitisInfections and infestations1/31/330/23
PharyngotonsillitisInfections and infestations1/30/330/23

Baseline characteristics

All participants who received at least 1 dose of study drug.

Age, Continuous
Age, Continuous(Years)Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg)Total
Mean6.0 ± 0.010.7 ± 2.6714.7 ± 1.7212.0 ± 3.26
Age, Customized
Age, Customized(Years)Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg)Total
Median6.0 (6 to 6)11.0 (6 to 16)15.0 (11 to 17)12.0 (6 to 17)
Sex: Female, Male
Sex: Female, Male(Participants)Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg)Total
Female2171130
Male1161229
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg)Total
Hispanic or Latino0123
Not Hispanic or Latino1225
Unknown or Not Reported2301951
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg)Total
White15410
Black/African American224935
Other041014
Region of Enrollment
Region of Enrollment(Participants)Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg)Total
Africa224834
Europe0101
North America1034
South America081220
Country
Country(Participants)Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg)Total
Argentina0303
Brazil0347
Chile0123
Mexico1012
Peru0167
Russia0101
South Africa224834
United States0022
08

Study locations

27 sites
  • Phoenix Children'S Hospital
    Phoenix, Arizona 85016, United States
  • Grady Health System Ponce Family And Youth Clinic
    Atlanta, Georgia 30322, United States
  • Children'S Medical Center Of Dallas
    Dallas, Texas 75235, United States
  • Local Institution
    Buenos Aires, Bs As, Buenos Aires 1141, Argentina
  • Local Institution
    Buenos Aires, 1181, Argentina
  • Local Institution
    Buenos Aires, 1425, Argentina
  • Local Institution
    Salvador, Bahia 40110-160, Brazil
  • Local Institution
    Salvador, Bahia 40110, Brazil
  • Local Institution
    Porto Alegre, RIO Grande DO SUL 90035-903, Brazil
  • Local Institution
    Porto Alegre, Rio Grande Do Sul 90035, Brazil
  • Local Institution
    Sao Paulo, SP 01416-901, Brazil
  • Local Institution
    Sao Paulo, 01246, Brazil
  • Local Institution
    Santiago, Metropolitana 8207257, Chile
  • Local Institution
    Santiago, Metropolitana 8380418, Chile
  • Local Institution
    Guadalajara, Jalisco 44280, Mexico
  • Local Institution
    Monterrey, Nuevo LEON 64000, Mexico
  • Local Institution
    Merida, Yucatan 97000, Mexico
  • Local Institution
    Puebla, 72000, Mexico
  • Local Institution
    Lima, 1, Peru
  • Local Institution
    Lima, LIMA 10, Peru
  • Local Institution
    Moscow, 129110, Russian Federation
  • Local Institution
    St. Petersburg, 190103, Russian Federation
  • Local Institution
    Port Elizabeth, Eastern CAPE 6001, South Africa
  • Local Institution
    Bloemfontein, FREE State 9301, South Africa
  • Local Institution
    Soweto, Gauteng 2013, South Africa
  • Local Institution
    Cape Town, Western CAPE 7505, South Africa
  • Local Institution
    Cape Town, Western CAPE 7530, South Africa
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01691794
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Sep 25, 2012
Start date
Nov 30, 2012
Primary completion
Oct 31, 2014
Completion
Feb 20, 2017
Results posted
Nov 30, 2015
Last update
Apr 27, 2018

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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