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Study to Evaluate the Effect of Voxelotor Administered Orally to Patients With Sickle Cell Disease (GBT_HOPE) (GBT_HOPE)

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ClinicalTrials.gov Identifier: NCT03036813
Recruitment Status : Completed
First Posted : January 30, 2017
Results First Posted : January 7, 2021
Last Update Posted : January 7, 2021
Sponsor:
Information provided by (Responsible Party):
Global Blood Therapeutics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Sickle Cell Disease
Interventions Drug: voxelotor
Other: Placebo
Enrollment 449
Recruitment Details Overall, 449 subjects were screened for this study at 60 study sites. Between January 2017 and May 2018, a total of 274 subjects were randomized at 58 study sites across 12 countries. All 274 randomized subjects were included in the ITT Population. A total of 271 subjects received study drug and were included in the Safety Population.
Pre-assignment Details Screening procedures were done within 35 days of randomization to assess eligibility.
Arm/Group Title Voxelotor 900mg Voxelotor 1500mg Placebo
Hide Arm/Group Description Participants received voxelotor 900 mg; administered orally, once daily for 72 weeks. Participants received voxelotor 1500 mg administered orally, once daily for 72 weeks. Matching placebo; administered orally, once daily for 72 weeks.
Period Title: Overall Study
Started 92 90 92
Completed 70 63 66
Not Completed 22 27 26
Reason Not Completed
Adverse Event             6             11             6
Withdrawal by Subject             12             6             10
Lost to Follow-up             1             1             0
Physician Decision             2             1             1
Non-Compliance             1             5             3
Pregnancy             0             0             1
Other             0             3             5
Arm/Group Title Voxelotor 900mg Voxelotor 1500mg Placebo Total
Hide Arm/Group Description Participants received voxelotor 900 mg; administered orally, once daily for 72 weeks. Participants received voxelotor 1500 mg; administered orally, once daily for 72 weeks Matching Placebo; administered orally, once daily for 72 weeks Total of all reporting groups
Overall Number of Baseline Participants 92 90 92 274
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 92 participants 90 participants 92 participants 274 participants
12 to < 18
15
  16.3%
14
  15.6%
17
  18.5%
46
  16.8%
>=18 to < 65
77
  83.7%
76
  84.4%
75
  81.5%
228
  83.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants 90 participants 92 participants 274 participants
Female
51
  55.4%
58
  64.4%
50
  54.3%
159
  58.0%
Male
41
  44.6%
32
  35.6%
42
  45.7%
115
  42.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants 90 participants 92 participants 274 participants
Hispanic or Latino
4
   4.3%
3
   3.3%
3
   3.3%
10
   3.6%
Not Hispanic or Latino
86
  93.5%
82
  91.1%
85
  92.4%
253
  92.3%
Unknown or Not Reported
2
   2.2%
5
   5.6%
4
   4.3%
11
   4.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 92 participants 90 participants 92 participants 274 participants
Arab/Middle Eastern
19
  20.7%
15
  16.7%
18
  19.6%
52
  19.0%
Black or African American
60
  65.2%
59
  65.6%
63
  68.5%
182
  66.4%
White
6
   6.5%
7
   7.8%
3
   3.3%
16
   5.8%
Asian
0
   0.0%
1
   1.1%
0
   0.0%
1
   0.4%
Other
4
   4.3%
2
   2.2%
5
   5.4%
11
   4.0%
Multiple
2
   2.2%
5
   5.6%
3
   3.3%
10
   3.6%
Missing/ Not Specified
1
   1.1%
1
   1.1%
0
   0.0%
2
   0.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 92 participants 90 participants 92 participants 274 participants
Europe 19 19 18 56
North America 36 34 35 105
Egypt 15 16 13 44
Kenya 17 14 18 49
Jamaica 0 2 2 4
Oman 2 2 5 9
Lebanon 3 3 1 7
1.Primary Outcome
Title Number of Participants With Increase in Hb >1 g/dL From Baseline to Week 24
Hide Description Number of participants with increase in Hb >1 g/dL from Baseline to Week 24
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subject (ITT population).
Arm/Group Title Voxelotor 900 mg Voxelotor 1500 mg Placebo
Hide Arm/Group Description:
Participants received voxelotor 900 mg administered orally, once daily
Participants received voxelotor 1500mg; administered orally, once daily
Participants received matching placebo; administered orally, once daily
Overall Number of Participants Analyzed 92 90 92
Measure Type: Count of Participants
Unit of Measure: Participants
30
  32.6%
46
  51.1%
6
   6.5%
2.Secondary Outcome
Title Annualized Vaso-Occlusive Crisis (VOC) Incidence Rate
Hide Description Number of Vaso-Occlusive Crisis (VOC) events averaged per year.
Time Frame Baseline to Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Population excludes 3 subjects (1 in the placebo group and 2 in the voxelotor 1500-mg group) who were not treated.
Arm/Group Title Voxelotor 900 mg Voxelotor 1500 mg Placebo
Hide Arm/Group Description:
Participants received voxelotor 900 mg; administered orally, once daily
Participants received voxelotor 1500 mg; administered orally, once daily
Participants received matching placebo; administered orally, once daily
Overall Number of Participants Analyzed 92 88 91
Mean (95% Confidence Interval)
Unit of Measure: Events per year
2.4
(1.9 to 3.1)
2.4
(1.8 to 3.1)
2.8
(2.2 to 3.6)
3.Secondary Outcome
Title Percentage Change From Baseline in Hemolysis Measures
Hide Description Percentage change from Baseline to week 24 in unconjugated bilirubin
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population includes all randomized patients with a baseline value and at least one post-baseline value
Arm/Group Title Voxelotor 900 mg Voxelotor 1500 mg Placebo
Hide Arm/Group Description:
Participants received voxelotor 900 mg; administered orally, once daily
Participants received voxelotor 1500 mg; administered orally, once daily
Participants received matching placebo; administered orally, once daily
Overall Number of Participants Analyzed 88 85 85
Least Squares Mean (Standard Error)
Unit of Measure: percentage change
-20.1  (3.41) -29.1  (3.46) -2.8  (3.51)
4.Secondary Outcome
Title Percentage Change From Baseline in Hemolysis Measures
Hide Description Percentage change from Baseline to week 24 in the absolute reticulocyte which is used to estimate the degree of effective erythropoiesis. This values is important in Sickle Cell Disease and was reported by the central laboratory.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Voxelotor 900 mg Voxelotor 1500 mg Placebo
Hide Arm/Group Description:
Participants received voxelotor 900 mg; administered orally, once daily
Participants received voxelotor 1500 mg; administered orally, once daily
Participants will receive matching placebo; administered orally, once daily
Overall Number of Participants Analyzed 92 88 91
Least Squares Mean (Standard Error)
Unit of Measure: percentage change
4.7  (5.13) -6.4  (5.17) 4.7  (5.19)
5.Secondary Outcome
Title Percentage Change From Baseline in Hemolysis Measures
Hide Description Percentage change from Baseline to week 24 in reticulocytes % which is a % of total Red Blood Cells (RBCs).
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Voxelotor 900 mg Voxelotor 1500 mg Placebo
Hide Arm/Group Description:
Participants received voxelotor 900 mg; administered orally, once daily
Participants received voxelotor 1500 mg; administered orally, once daily
Participants received matching placebo; administered orally, once daily
Overall Number of Participants Analyzed 92 88 91
Least Squares Mean (Standard Error)
Unit of Measure: Percentage Change
-1.4  (4.65) -18.0  (4.70) 6.8  (4.73)
6.Secondary Outcome
Title Percentage Change From Baseline in Hemolysis Measures
Hide Description Percentage change from Baseline to week 24 in Lactate Dehydrogenase (LDH)
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population includes all randomized patients with a baseline value and at least one post-baseline value
Arm/Group Title Voxelotor 900 mg Voxelotor 1500 mg Placebo
Hide Arm/Group Description:
Participants received voxelotor 900 mg; administered orally, once daily
Participants received voxelotor 1500 mg; administered orally, once daily
Participants received matching placebo; administered orally, once daily
Overall Number of Participants Analyzed 90 88 87
Least Squares Mean (Standard Error)
Unit of Measure: Percentage Change
1.6  (3.68) -4.6  (3.69) 3.0  (3.75)
Time Frame 72 Weeks
Adverse Event Reporting Description Non-sickle cell disease (Non-SCD) related Adverse Events.
 
Arm/Group Title Voxelotor 900 mg Voxelotor 1500 mg Placebo
Hide Arm/Group Description Participants received voxelotor 900 mg, administered orally, once daily Participants received voxelotor 1500 mg administered orally, once daily Participants received matching placebo; administered orally, once daily
All-Cause Mortality
Voxelotor 900 mg Voxelotor 1500 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/92 (2.17%)      2/88 (2.27%)      2/91 (2.20%)    
Hide Serious Adverse Events
Voxelotor 900 mg Voxelotor 1500 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/92 (21.74%)      25/88 (28.41%)      23/91 (25.27%)    
Blood and lymphatic system disorders       
Anaemia † 1  3/92 (3.26%)  3 0/88 (0.00%)  0 2/91 (2.20%)  2
Hypersplenism † 1  0/92 (0.00%)  0 1/88 (1.14%)  1 0/91 (0.00%)  0
Reticulocytopenia † 1  0/92 (0.00%)  0 1/88 (1.14%)  1 0/91 (0.00%)  0
Thrombocytopenia † 1  1/92 (1.09%)  1 0/88 (0.00%)  0 0/91 (0.00%)  0
Haemolytic anaemia † 1  0/92 (0.00%)  0 0/88 (0.00%)  0 1/91 (1.10%)  1
Splenic infarction † 1  0/92 (0.00%)  0 0/88 (0.00%)  0 1/91 (1.10%)  1
Thrombocytosis † 1  0/92 (0.00%)  0 0/88 (0.00%)  0 1/91 (1.10%)  1
Cardiac disorders       
Cardiac failure high output † 1  0/92 (0.00%)  0 1/88 (1.14%)  2 0/91 (0.00%)  0
Supraventricular tachycardia † 1  1/92 (1.09%)  2 0/88 (0.00%)  0 0/91 (0.00%)  0
Cardiac arrest † 1  0/92 (0.00%)  0 0/88 (0.00%)  0 1/91 (1.10%)  1
Eye disorders       
Blindness † 1  0/92 (0.00%)  0 1/88 (1.14%)  1 0/91 (0.00%)  0
Retinal haemorrhage † 1  0/92 (0.00%)  0 1/88 (1.14%)  1 0/91 (0.00%)  0
Vitreous haemorrhage † 1  0/92 (0.00%)  0 1/88 (1.14%)  1 0/91 (0.00%)  0
Gastrointestinal disorders       
Gastritis † 1  2/92 (2.17%)  2 0/88 (0.00%)  0 0/91 (0.00%)  0
Nausea † 1  0/92 (0.00%)  0 1/88 (1.14%)  1 0/91 (0.00%)  0
Diarrhoea † 1  1/92 (1.09%)  1 0/88 (0.00%)  0 0/91 (0.00%)  0
Gastritis haemorrhagic † 1  1/92 (1.09%)  1 0/88 (0.00%)  0 0/91 (0.00%)  0
Odynophagia † 1  0/92 (0.00%)  0 0/88 (0.00%)  0 1/91 (1.10%)  1
General disorders       
Pyrexia † 1  3/92 (3.26%)  4 2/88 (2.27%)  2 3/91 (3.30%)  3
Non-cardiac chest pain † 1  0/92 (0.00%)  0 1/88 (1.14%)  1 0/91 (0.00%)  0
Peripherial swelling † 1  0/92 (0.00%)  0 0/88 (0.00%)  0 1/91 (1.10%)  1
Hepatobiliary disorders       
Cholecystitis † 1  0/92 (0.00%)  0 1/88 (1.14%)  1 0/91 (0.00%)  0
Hepatic sequestration † 1  0/92 (0.00%)  0 1/88 (1.14%)  1 0/91 (0.00%)  0
Cholelithiasis † 1  1/92 (1.09%)  1 0/88 (0.00%)  0 1/91 (1.10%)  1
Hepatitis acute † 1  1/92 (1.09%)  1 0/88 (0.00%)  0 0/91 (0.00%)  0
Immune system disorders       
Drug hypersensitivity † 1  0/92 (0.00%)  0 1/88 (1.14%)  1 0/91 (0.00%)  0
Infections and infestations       
Malaria † 1  3/92 (3.26%)  5 1/88 (1.14%)  1 0/91 (0.00%)  0
Upper respiratory tract infection † 1  0/92 (0.00%)  0 1/88 (1.14%)  1 1/91 (1.10%)  1
Appendicitis † 1  0/92 (0.00%)  0 1/88 (1.14%)  1 0/91 (0.00%)  0
Brain abscess † 1  0/92 (0.00%)  0 1/88 (1.14%)  1 0/91 (0.00%)  0
Gastrointestinal viral infection † 1  0/92 (0.00%)  0 1/88 (1.14%)  1 0/91 (0.00%)  0
Pulmonary sepsis † 1  0/92 (0.00%)  0 1/88 (1.14%)  1 0/91 (0.00%)  0
Tonsillitis † 1  0/92 (0.00%)  0 1/88 (1.14%)  1 0/91 (0.00%)  0
Cellulitis † 1  1/92 (1.09%)  1 0/88 (0.00%)  0 1/91 (1.10%)  1
Lower respiratory tract infection † 1  1/92 (1.09%)  1 0/88 (0.00%)  0 1/91 (1.10%)  1
Urinary tract infection † 1  1/92 (1.09%)  1 0/88 (0.00%)  0 1/91 (1.10%)  1
Pharyngitis † 1  1/92 (1.09%)  1 0/88 (0.00%)  0 0/91 (0.00%)  0
Sepsis † 1  1/92 (1.09%)  1 0/88 (0.00%)  0 0/91 (0.00%)  0
Sepsis syndrome † 1  1/92 (1.09%)  1 0/88 (0.00%)  0 0/91 (0.00%)  0
Gastroenteritis † 1  0/92 (0.00%)  0 0/88 (0.00%)  0 1/91 (1.10%)  1
Gastroenteritis viral † 1  0/92 (0.00%)  0 0/88 (0.00%)  0 1/91 (1.10%)  1
Influenza † 1  0/92 (0.00%)  0 0/88 (0.00%)  0 1/91 (1.10%)  1
Lung infection † 1  0/92 (0.00%)  0 0/88 (0.00%)  0 1/91 (1.10%)  1
Injury, poisoning and procedural complications       
Patella fracture † 1  0/92 (0.00%)  0 1/88 (1.14%)  1 0/91 (0.00%)  0
Lower limb fracture † 1  1/92 (1.09%)  1 0/88 (0.00%)  0 0/91 (0.00%)  0
Spinal compression fracture † 1  0/92 (0.00%)  0 0/88 (0.00%)  0 1/91 (1.10%)  1
Medication error † 1  0/92 (0.00%)  0 1/88 (1.14%)  1 0/91 (0.00%)  0
Investigations       
Oxygen saturation decreased † 1  0/92 (0.00%)  0 1/88 (1.14%)  1 0/91 (0.00%)  0
Haemoglobin decreased † 1  1/92 (1.09%)  1 0/88 (0.00%)  0 0/91 (0.00%)  0
Metabolism and nutrition disorders       
Gout † 1  1/92 (1.09%)  1 0/88 (0.00%)  0 0/91 (0.00%)  0
Hypokalaemia † 1  1/92 (1.09%)  1 0/88 (0.00%)  0 0/91 (0.00%)  0
Type 2 diabetes mellitus † 1  1/92 (1.09%)  1 0/88 (0.00%)  0 0/91 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Musculoskeletal chest pain † 1  2/92 (2.17%)  2 0/88 (0.00%)  0 1/91 (1.10%)  1
Arthralgia † 1  0/92 (0.00%)  0 1/88 (1.14%)  1 0/91 (0.00%)  0
Arthritis † 1  0/92 (0.00%)  0 1/88 (1.14%)  1 0/91 (0.00%)  0
Back pain † 1  1/92 (1.09%)  1 0/88 (0.00%)  0 0/91 (0.00%)  0
Pain in extemity † 1  1/92 (1.09%)  1 0/88 (0.00%)  0 0/91 (0.00%)  0
Costochondritis † 1  0/92 (0.00%)  0 0/88 (0.00%)  0 1/91 (1.10%)  1
Musculoskeletal pain † 1  0/92 (0.00%)  0 0/88 (0.00%)  0 1/91 (1.10%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Uterine leiomyoma † 1  1/92 (1.09%)  1 0/88 (0.00%)  0 0/91 (0.00%)  0
Nervous system disorders       
Encephalopathy † 1  0/92 (0.00%)  0 1/88 (1.14%)  1 0/91 (0.00%)  0
Headache † 1  0/92 (0.00%)  0 1/88 (1.14%)  1 0/91 (0.00%)  0
Seizure † 1  0/92 (0.00%)  0 1/88 (1.14%)  1 0/91 (0.00%)  0
Cerebrovascular accident † 1  1/92 (1.09%)  1 0/88 (0.00%)  0 0/91 (0.00%)  0
Cerebral microhaemorrhage † 1  0/92 (0.00%)  0 0/88 (0.00%)  0 1/91 (1.10%)  1
Depressed level of consciousness † 1  0/92 (0.00%)  0 0/88 (0.00%)  0 1/91 (1.10%)  1
Hyperaesthesia † 1  0/92 (0.00%)  0 0/88 (0.00%)  0 1/91 (1.10%)  1
Respiratory, thoracic and mediastinal disorders       
Pleural effusion † 1  0/92 (0.00%)  0 2/88 (2.27%)  2 0/91 (0.00%)  0
Pulmonary embolism † 1  0/92 (0.00%)  0 2/88 (2.27%)  2 1/91 (1.10%)  1
Respiratory failure † 1  0/92 (0.00%)  0 1/88 (1.14%)  1 1/91 (1.10%)  1
Acute respiratory failure † 1  0/92 (0.00%)  0 1/88 (1.14%)  1 0/91 (0.00%)  0
Skin and subcutaneous tissue disorders       
Rash generalised † 1  1/92 (1.09%)  1 0/88 (0.00%)  0 0/91 (0.00%)  0
Surgical and medical procedures       
Cholecystectomy † 1  0/92 (0.00%)  0 1/88 (1.14%)  1 1/91 (1.10%)  1
1
Term from vocabulary, MedDRA (22.0)
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Voxelotor 900 mg Voxelotor 1500 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   85/92 (92.39%)      85/88 (96.59%)      81/91 (89.01%)    
Blood and lymphatic system disorders       
Anaemia † 1  6/92 (6.52%)  9 4/88 (4.55%)  4 2/91 (2.20%)  2
Gastrointestinal disorders       
Diarrhoea † 1  17/92 (18.48%)  24 20/88 (22.73%)  22 10/91 (10.99%)  12
Nausea † 1  17/92 (18.48%)  21 16/88 (18.18%)  21 9/91 (9.89%)  17
Abdominal pain † 1  13/92 (14.13%)  15 13/88 (14.77%)  17 10/91 (10.99%)  12
Vomiting † 1  13/92 (14.13%)  20 11/88 (12.50%)  17 15/91 (16.48%)  24
Abdominal pain upper † 1  14/92 (15.22%)  19 8/88 (9.09%)  9 6/91 (6.59%)  10
Constipation † 1  9/92 (9.78%)  9 6/88 (6.82%)  7 9/91 (9.89%)  9
Gastritis † 1  5/92 (5.43%)  7 3/88 (3.41%)  8 4/91 (4.40%)  4
General disorders       
Pain † 1  15/92 (16.30%)  27 15/88 (17.05%)  27 18/91 (19.78%)  22
Fatigue † 1  13/92 (14.13%)  16 12/88 (13.64%)  14 12/91 (13.19%)  15
Pyrexia † 1  10/92 (10.87%)  13 11/88 (12.50%)  13 4/91 (4.40%)  5
Non-cardiac chest pain † 1  13/92 (14.13%)  15 9/88 (10.23%)  10 10/91 (10.99%)  10
Hepatobiliary disorders       
Ocular icterus † 1  9/92 (9.78%)  15 6/88 (6.82%)  7 8/91 (8.79%)  14
Infections and infestations       
Upper respiratory tract infection † 1  22/92 (23.91%)  26 12/88 (13.64%)  13 13/91 (14.29%)  18
Urinary tract infection † 1  5/92 (5.43%)  8 9/88 (10.23%)  10 13/91 (14.29%)  15
Tonsillitis † 1  3/92 (3.26%)  5 5/88 (5.68%)  7 8/91 (8.79%)  10
Malaria † 1  2/92 (2.17%)  5 5/88 (5.68%)  8 3/91 (3.30%)  6
Influenza † 1  4/92 (4.35%)  5 3/88 (3.41%)  3 5/91 (5.49%)  6
Gastroenteritis † 1  6/92 (6.52%)  6 2/88 (2.27%)  2 3/91 (3.30%)  5
Metabolism and nutrition disorders       
Decreased appetite † 1  6/92 (6.52%)  6 2/88 (2.27%)  2 0/91 (0.00%)  0
Hypokalaemia † 1  3/92 (3.26%)  3 2/88 (2.27%)  4 5/91 (5.49%)  5
Musculoskeletal and connective tissue disorders       
Arthralgia † 1  14/92 (15.22%)  24 18/88 (20.45%)  33 13/91 (14.29%)  17
Back pain † 1  12/92 (13.04%)  25 15/88 (17.05%)  17 12/91 (13.19%)  16
Pain in extremity † 1  20/92 (21.74%)  33 12/88 (13.64%)  19 19/91 (20.88%)  22
Musculoskeletal pain † 1  4/92 (4.35%)  4 6/88 (6.82%)  6 4/91 (4.40%)  4
Bone pain † 1  1/92 (1.09%)  5 5/88 (5.68%)  9 8/91 (8.79%)  22
Musculoskeletal chest pain † 1  0/92 (0.00%)  0 2/88 (2.27%)  3 5/91 (5.49%)  5
Nervous system disorders       
Headache † 1  20/92 (21.74%)  22 27/88 (30.68%)  33 23/91 (25.27%)  34
Dizziness † 1  8/92 (8.70%)  10 4/88 (4.55%)  4 9/91 (9.89%)  9
Respiratory, thoracic and mediastinal disorders       
Cough † 1  6/92 (6.52%)  7 8/88 (9.09%)  10 10/91 (10.99%)  11
Oropharyngeal pain † 1  1/92 (1.09%)  1 7/88 (7.95%)  9 1/91 (1.10%)  1
Dyspnoea † 1  5/92 (5.43%)  5 2/88 (2.27%)  2 4/91 (4.40%)  6
Skin and subcutaneous tissue disorders       
Rash † 1  5/92 (5.43%)  5 6/88 (6.82%)  9 8/91 (8.79%)  8
Pruritus † 1  5/92 (5.43%)  8 4/88 (4.55%)  4 3/91 (3.30%)  6
1
Term from vocabulary, MedDRA (22.0)
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Layout table for Results Point of Contact information
Name/Title: Margaret Tonda, PharmD, Sr. Director, Clinical Science
Organization: Global Blood Therapeutics
Phone: (650) 741-7761
EMail: mtonda@gbt.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Global Blood Therapeutics
ClinicalTrials.gov Identifier: NCT03036813    
Other Study ID Numbers: GBT440-031
First Submitted: January 27, 2017
First Posted: January 30, 2017
Results First Submitted: October 28, 2020
Results First Posted: January 7, 2021
Last Update Posted: January 7, 2021