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CompletedNCT03397888Updated Feb 21, 2023

The Effect o f Hepatic Impairment on the Pharmacokinetics and Pharmacodynamics of Betrixiban, an Oral FXa Antagonist

A Phase 1 interventional study of Betrixaban in Hepatic Impairment, sponsored by Portola Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-21.

Sponsored by Portola Pharmaceuticals (part of AstraZeneca) · Phase 1, Interventional, and Prevention

From the registry’s dates

  • Primary completion was Jan 2018, 8 years 9 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Single center, prospective open label PK and PD study of betrixaban in subjects with mild and moderate hepatic impairment vs healthy volunteers.

02

Conditions studied

  • Hepatic Impairment
03

In context

Lead sponsor

Portola Pharmaceuticals is the lead sponsor of 23 studies on the registry; none are open to participants now.

First submitted before Portola Pharmaceuticals became part of AstraZeneca.

Browse Portola Pharmaceuticals studies →All AstraZeneca studies →

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

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Cohorts 1 \& 2: Man or a woman 18 to 70 with stable chronic hepatic impairment disease due to cirrhosis confirmed by , ultrasound, CT or MRI (Cohort 1 - Mild impairment, Category A; Cohort 2 - Moderate Impairment, Child-Pugh Category B). Cohort 3: essentially healthy man or woman without liver disease whose sex, age and weight match patients in Cohorts 1 \& 2 in order to result in similar average demographics.
  2. between 18 and 35 kg*m-2 and weighs at least 50 kg.
  3. . Men must agree to acceptable methods of contraception. Women of must agree to two acceptable forms of contraception. women must have had no regular menstrual bleeding for at least one year prior to initial dosing and confirmed by an elevated plasma Follicle-stimulating hormone level test at screening for women not in receipt of hormone replacement therapy (HRT). Women who report surgical sterilization must have had the procedure at least six months prior to dosing, supported by clinical documentation.
  4. The subject has clinical unremarkable medical history, physical examination, , laboratory values and vital signs, as determined by the investigator. Subjects in Cohorts 1 \& 2 may have: abnormal liver function tests, up to 2.2, PT up to 6 seconds over control, aPPT up to 45 seconds and down to 45,000/uL.
  5. The subject smokes \<12 cigarettes per day or equivalent and agrees to no or reduced tobacco products while domiciled.
  6. The subject is able to read and give written and signed the IRB approved consent form.
  7. The subject has adequate venous access for blood sampling.

Exclusion criteria

Exclusion Criteria:

  1. The subject has a history, symptoms of, or risk factors for bleeding or a stool specimen within 6 months of dosing positive for occult blood.
  2. The subject has an absolute/relative to anticoagulation due to: history of intracranial bleeding, severe active bleeding, recent brain, eye, or spinal cord surgery or major surgery within 6 months of dosing.
  3. The subject has a history of or risk factors for a hypercoagulable or thrombotic condition.
  4. The subject has a history of any cardiac, endocrinologic, hematologic, hepatic (except for Cohorts 1 \& 2), immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal or other major disease other than the underlying disease in Cohorts 1 \& 2.
  5. The subject has a calculated of \<60mL/min as determined by Cockcroft-Gault method.

  6. Concomitant medication use:

    1. For all subjects, illicit drugs, oral , and hormone replacement therapy are excluded within 30 days prior to Day -1.
    2. For all subjects, over the counter drugs, including dietary supplements and herbal products are excluded within 14 days prior to Day -1.
    3. Subjects enrolled in Cohort 3 will be excluded if the subject has taken any prescription drugs in the 30 days prior to dosing. Furthermore, the subject will be excluded if he/she does not agree to refrain from concomitant drugs throughout the study unless medically necessary as determined by the Investigator.
    4. Subjects enrolled in Cohort 1 and 2 may continue taking stable preexisting medications throughout the study with the exception of strong P-gp inhibitors. Strong P-gp inhibitors include but are not limited to: amiodarone, azithromycin, clarithromycin, erythromycin, ketoconazole, and verapamil. Prescribed stable acetaminophen use up to 2,000 mg per day is allowable. Any acetaminophen use with alcohol within 48 hours of dosing is prohibited. Furthermore, the subject will be excluded if he/she does not agree to refrain from additional concomitant drugs throughout the study unless medically necessary as determined by the Investigator.
  7. The subject has a history of severe trauma or bone fracture within 6 months prior to dosing; or planned surgery within 1 month after dosing.
  8. The subject has a history of blood donation of more than 500mL within 3 months prior to dosing.
  9. The subject has received an drug product within 30 days or 5 half-lives of the investigational compound, whichever is greater, from Day -1.
  10. The subject has positive screen for drugs of abuse at Day -1.
  11. The subject does not agree to withhold from alcohol consumption from 48 hours prior to dosing through discharge.
  12. The subject has a medical or surgical condition which may impair drug absorption.
  13. The subject is pregnant or breastfeeding.
  14. The subject has any condition which could interfere with or for which the treatment might interfere with the conduct of the study, or would, in the opinion of the Investigator, increase the risk of the subject's participation in the study.
Terms in these criteria, in plain language(14)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Cohort 1

    Mild Impairment, Child-Pugh Category A

    Drug: Betrixaban

  • Experimental
    Cohort 2

    Moderate Impairment, Child-Pugh Category B

    Drug: Betrixaban

  • Experimental
    Cohort 3

    Essentially Healthy man or woman without liver disease matched to Cohorts 1 \& 2 for age, sex and weight.

    Drug: Betrixaban

Interventions

06

What researchers measure

Primary outcomes

  1. PK - Plasma half-life (t1/2)

    Plasma half-life (t1/2), distribution half-life and terminal half-life.

    Time frame: Day 1 through Day 6

  2. PK - Tmax

    Time to maximum observed plasma concentration (Tmax).

    Time frame: Day 1 through Day 6

  3. PK - Cmax

    Maximum observed plasma concentration (Cmax)

    Time frame: Day 1 through Day 6

  4. PK - AUC (0-last)

    Area under the plasma concentration-time curve from 0 to last measurable concentration (AUC (0-last)).

    Time frame: Day 1 through Day 6

  5. PK - (AUC(0-∞)).

    Total area under the plasma concentration-time curve from time 0 to infinity (AUC(0-∞)).

    Time frame: Day 1 through Day 6

  6. PK - Volume of distribution

    Apparent volume of distribution (Vd/F).

    Time frame: Day 1 through Day 6

  7. PK - Total clearance

    Apparent total clearance (CL/F).

    Time frame: Day 1 through Day 6

Secondary outcomes

  1. Safety - Treatment Emergent AEs

    Safety evaluation will study the adverse event (AE) profile

    Time frame: Day -1 through up to Day 21

  2. Safety - Demographics

    Safety will be evaluated by assessment of Demographics

    Time frame: Day -30 through Day -2 (Screening)

  3. Safety - Vital Signs Temperature

    Safety will be evaluated by assessment of Temperature - Celsius

    Time frame: Day -30 through up to Day 21

  4. Safety - Vital Signs Respiratory Rate

    Safety will be evaluated by assessment of Respiratory Rate - Breaths per Minute

    Time frame: Day -30 through up to Day 21

  5. Safety - Vital Signs Heart Rate

    Safety will be evaluated by assessment of Heart Rate - Beats per Minute

    Time frame: Day -30 through up to Day 21

  6. Safety - Vital Signs Blood Pressure

    Safety will be evaluated by assessment of Blood Pressure - mmHg

    Time frame: Day -30 through up to Day 21

  7. Safety - 12 Lead ECG - PR

    Safety will be evaluated by assessment of 12 ECG - PR (ms)

    Time frame: Day -30 through up to Day 21

  8. Safety - 12 Lead ECG - RR

    Safety will be evaluated by assessment of 12 ECG - RR (ms)

    Time frame: Day -30 through up to Day 21

  9. Safety - 12 Lead ECG - WRS

    Safety will be evaluated by assessment of 12 ECG - WRS (ms)

    Time frame: Day -30 through up to Day 21

  10. Safety - 12 Lead ECG - QT

    Safety will be evaluated by assessment of 12 ECG - QT (ms)

    Time frame: Day -30 through up to Day 21

  11. Safety - 12 Lead ECG - QTcF

    Safety will be evaluated by assessment of 12 ECG - QTcF (ms)

    Time frame: Day -30 through up to Day 21

  12. Safety - 12 Lead ECG - QTcB

    Safety will be evaluated by assessment of 12 ECG - QTcB (ms)

    Time frame: Day -30 through up to Day 21

  13. Safety - Physical Exam - Height

    Safety will be evaluated by assessment Physical Exam - Height (centimeters)

    Time frame: Day -30 through up to Day 21

  14. Safety - Physical Exam - Weight

    Safety will be evaluated by assessment Physical Exam - Weight (kilogram)

    Time frame: Day -30 through up to Day 21

  15. Safety - Lab - Hematology - hemoglobin

    Safety will be evaluated by analyzing Hematology - hemoglobin (g/dL)

    Time frame: Day -30 through up to Day 21

  16. Safety - Lab - Hematology - hematocrit

    Safety will be evaluated by analyzing Hematology - hematocrit (%)

    Time frame: Day -30 through up to Day 21

  17. Safety - Lab - Hematology - white blood cell [WBC]

    Safety will be evaluated by analyzing Hematology - WBC (K/UL)

    Time frame: Day -30 through up to Day 21

  18. Safety - Lab - Hematology - Platelet Count

    Safety will be evaluated by analyzing Platelet Count (Plt/mL)

    Time frame: Day -30 through up to Day 21

  19. Safety - Lab - Hematology - Absolute Neutrophil Count

    Safety will be evaluated by analyzing Absolute Neutrophil Count (K/UL)

    Time frame: Day -30 through up to Day 21

  20. Safety - Lab - Hematology - Absolute Basophils

    Safety will be evaluated by analyzing Absolute Basophils (K/UL)

    Time frame: Day -30 through up to Day 21

  21. Safety - Lab - Hematology - Eosinophil's

    Safety will be evaluated by analyzing Eosinophil's (K/UL)

    Time frame: Day -30 through up to Day 21

  22. Safety - Lab - Hematology - Lymphocytes

    Safety will be evaluated by analyzing Lymphocytes (K/UL)

    Time frame: Day -30 through up to Day 21

  23. Safety - Lab - Hematology - Mean Corpuscular Hemoglobin

    Safety will be evaluated by analyzing Mean Corpuscular Hemoglobin (PG)

    Time frame: Day -30 through up to Day 21

  24. Safety - Lab - Hematology - Mean Corpuscular Hemoglobin Concentration

    Safety will be evaluated by analyzing Mean Corpuscular Hemoglobin Concentration (g/dL)

    Time frame: Day -30 through up to Day 21

  25. Safety - Lab - Hematology - Mean Corpuscular Hemoglobin Volume

    Safety will be evaluated by analyzing Mean Corpuscular Hemoglobin Volume (FL)

    Time frame: Day -30 through up to Day 21

  26. Safety - Lab - Hematology - Monocytes

    Safety will be evaluated by analyzing Monocytes (K/UL)

    Time frame: Day -30 through up to Day 21

  27. Safety - Lab - Hematology - Neutrophils

    Safety will be evaluated by analyzing Neutrophils (K/UL)

    Time frame: Day -30 through up to Day 21

  28. Safety - Lab - Hematology - Red Blood Cell Count

    Safety will be evaluated by analyzing Red Blood Cell Count (MIL/UL)

    Time frame: Day -30 through up to Day 21

  29. Safety - Lab - Hematology - Red Cell Distribution Width

    Safety will be evaluated by analyzing Red Cell Distribution Width (%)

    Time frame: Day -30 through up to Day 21

  30. Safety - Lab - Hematology - Reticulocyte

    Safety will be evaluated by analyzing Reticulocyte (K/UL)

    Time frame: Day -30 through up to Day 21

  31. Safety- Lab - Coagulation - PT

    Safety will be evaluated by analyzing Coagulation - PT (seconds)

    Time frame: Day -30 through up to Day 21

  32. Safety- Lab - Coagulation - INR

    Safety will be evaluated by analyzing Coagulation - INR (no unit)

    Time frame: Day -30 through up to Day 21

  33. Safety- Lab - Coagulation - aPTT

    Safety will be evaluated by analyzing Coagulation - aPTT (seconds)

    Time frame: Day -30 through up to Day 21

  34. Safety- Lab - Coagulation - Factor V Leiden

    Safety will be evaluated by analyzing Coagulation - Factor V Leiden (positive/negative)

    Time frame: Day -30 through up to Day 21

  35. Safety - Lab - Serum Chemistry - Sodium

    Safety will be evaluated by analyzing Serum Chemistry - Sodium (mEq/L)

    Time frame: Day -30 through up to Day 21

  36. Safety - Lab - Serum Chemistry - Potassium

    Safety will be evaluated by analyzing Serum Chemistry - Potassium (mEq/L)

    Time frame: Day -30 through up to Day 21

  37. Safety - Lab - Serum Chemistry - Chloride

    Safety will be evaluated by analyzing Serum Chemistry - Chloride (mEq/L)

    Time frame: Day -30 through up to Day 21

  38. Safety - Lab - Serum Chemistry - Carbon Dioxide

    Safety will be evaluated by analyzing Serum Chemistry - Carbon Dioxide (mEq/L)

    Time frame: Day -30 through up to Day 21

  39. Safety - Lab - Serum Chemistry - Glucose

    Safety will be evaluated by analyzing Serum Chemistry - Glucose (mg/dL)

    Time frame: Day -30 through up to Day 21

  40. Safety - Lab - Serum Chemistry - Blood Urea Nitrogen

    Safety will be evaluated by analyzing Serum Chemistry - Blood Urea Nitrogen (mg/dL)

    Time frame: Day -30 through up to Day 21

  41. Safety - Lab - Serum Chemistry - Creatinine

    Safety will be evaluated by analyzing Serum Chemistry - Creatinine (mg/dL)

    Time frame: Day -30 through up to Day 21

  42. Safety - Lab - Serum Chemistry - AST

    Safety will be evaluated by analyzing Serum Chemistry - AST (U/L)

    Time frame: Day -30 through up to Day 21

  43. Safety - Lab - Serum Chemistry - ALT

    Safety will be evaluated by analyzing Serum Chemistry - ALT (U/L)

    Time frame: Day -30 through up to Day 21

  44. Safety - Lab - Serum Chemistry - GGT

    Safety will be evaluated by analyzing Serum Chemistry - GGT (U/L)

    Time frame: Day -30 through up to Day 21

  45. Safety - Lab - Serum Chemistry - Total Protein

    Safety will be evaluated by analyzing Serum Chemistry - Total Protein (g/dL)

    Time frame: Day -30 through up to Day 21

  46. Safety - Lab - Serum Chemistry - Albumin

    Safety will be evaluated by analyzing Serum Chemistry - Albumin(g/dL)

    Time frame: Day -30 through up to Day 21

  47. Safety - Lab - Serum Chemistry - Alkaline Phosphatase

    Safety will be evaluated by analyzing Serum Chemistry - Alkaline Phosphatase (U/L)

    Time frame: Day -30 through up to Day 21

  48. Safety - Lab - Serum Chemistry - Calcium

    Safety will be evaluated by analyzing Serum Chemistry - Calcium (mg/dL)

    Time frame: Day -30 through up to Day 21

  49. Safety - Lab - Serum Chemistry - Phosphorus

    Safety will be evaluated by analyzing Serum Chemistry - Phosphorus (mg/dL)

    Time frame: Day -30 through up to Day 21

  50. Safety - Lab - Serum Chemistry - Total Bilirubin

    Safety will be evaluated by analyzing Serum Chemistry - Total Bilirubin (mg/dL)

    Time frame: Day -30 through up to Day 21

  51. Safety - Lab - Serum Chemistry - Fractionated Bilirubin

    Safety will be evaluated by analyzing Serum Chemistry - Fractionated Bilirubin(mg/dL)

    Time frame: Day -30 through up to Day 21

  52. Safety - Lab - Serum Chemistry - Uric Acid

    Safety will be evaluated by analyzing Serum Chemistry - Uric Acid (mg/dL)

    Time frame: Day -30 through up to Day 21

  53. Safety - Lab - Serum Chemistry - LDH

    Safety will be evaluated by analyzing Serum Chemistry LDH (U/L)

    Time frame: Day -30 through up to Day 21

  54. Safety - Lab - Urine toxicology Panel - Amphetamines

    Safety will be evaluated by analyzing Urine toxicology Panel - Amphetamines (NG/ML)

    Time frame: Day -30 through Day -1

  55. Safety - Lab - Urine toxicology Panel - Barbiturates

    Safety will be evaluated by analyzing Urine toxicology Panel - Barbiturates (NG/ML)

    Time frame: Day -30 through Day -1

  56. Safety - Lab - Urine toxicology Panel - Cannabinoids

    Safety will be evaluated by analyzing Urine toxicology Panel - Cannabinoids (NG/ML)

    Time frame: Day -30 through Day -1

  57. Safety - Lab - Urine toxicology Panel - Cocaine

    Safety will be evaluated by analyzing Urine toxicology Panel - Cocaine (NG/ML)

    Time frame: Day -30 through Day -1

  58. Safety - Lab - Urine toxicology Panel - Ethanol

    Safety will be evaluated by analyzing Urine toxicology Panel - Ethanol (MG/DL)

    Time frame: Day -30 through Day -1

  59. Safety - Lab - Urine toxicology Panel - Opiates

    Safety will be evaluated by analyzing Urine toxicology Panel - Opiates (NG/ML)

    Time frame: Day -30 through Day -1

  60. Safety - Lab - Urinalysis - Specific Gravity

    Safety will be evaluated by analyzing Urinalysis - Specific Gravity (no unit)

    Time frame: Day -30 through up to Day 21

  61. Safety - Lab - Urinalysis - pH

    Safety will be evaluated by analyzing Urinalysis - pH (no unit)

    Time frame: Day -30 through up to Day 21

  62. Safety - Lab - Urinalysis - Glucose

    Safety will be evaluated by analyzing Urinalysis - Glucose (no unit)

    Time frame: Day -30 through up to Day 21

  63. Safety - Lab - Urinalysis - Protein

    Safety will be evaluated by analyzing Urinalysis - Protein (no unit)

    Time frame: Day -30 through up to Day 21

  64. Safety - Lab - Urinalysis - Hemoglobin

    Safety will be evaluated by analyzing Urinalysis - Hemoglobin (no unit)

    Time frame: Day -30 through up to Day 21

  65. Safety - Lab - Urinalysis - Leukocyte esterase

    Safety will be evaluated by analyzing Urinalysis - Leukocyte esterase (no unit)

    Time frame: Day -30 through up to Day 21

  66. Safety - Lab - Urinalysis - Nitrate

    Safety will be evaluated by analyzing Urinalysis - Nitrate (no unit)

    Time frame: Day -30 through up to Day 21

  67. Safety - Urine Occult Blood Testing

    Safety will be evaluated by assessment of Urine Occult Blood Testing (positive/negative)

    Time frame: Day -30 through Day -2 (screening)

  68. Safety - Fecal Occult Blood Testing

    Safety will be evaluated by assessment of Fecal Occult Blood Testing (positive/negative)

    Time frame: Day -30 through Day -2 (screening)

  69. Safety - Lab - Blood Virology - HIV I

    Safety will be evaluated by analyzing Blood Virology - HIV I (positive/negative)

    Time frame: Day-30 through Day -2 (Screening)

  70. Safety - Lab - Blood Virology - HIV II

    Safety will be evaluated by analyzing Blood Virology - HIV II (positive/negative)

    Time frame: Day-30 through Day -2 (Screening)

  71. Safety - Lab - Blood Virology - Hepatitis B

    Safety will be evaluated by analyzing Blood Virology - Hepatitis B (positive/negative)

    Time frame: Day-30 through Day -2 (Screening)

  72. Safety - Lab - Blood Virology - Hepatitis C

    Safety will be evaluated by analyzing Blood Virology - Hepatitis C (positive/negative)

    Time frame: Day-30 through Day -2 (Screening)

  73. Safety - Lab - Serum Pregnancy

    Safety will be evaluated by analyzing Serum Pregnancy

    Time frame: Day -30 through up to Day 21

  74. PD - Anti-Factor Xa Concentration

    Anti-fXa will be analyzed for changes/percent changes from baseline over time.

    Time frame: Day 1 through Day 6

  75. PD - Thrombin Concentrations

    Thrombin will be analyzed for changes/percent changes from baseline over time.

    Time frame: Day 1 through Day 6

07

Study locations

1 site
  • Clinical Pharmacology of Miami
    Hialeah, Florida 33014, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2017 to primary completion in Jan 2018, 2 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 7, 2017
First posted
Jan 12, 2018
StartActual
Nov 16, 2017
Primary completionActual
Jan 16, 2018
CompletionActual
Jan 16, 2018
Last update
Feb 21, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03397888
Lead sponsor
Portola Pharmaceuticals
Responsible party
Sponsor
First posted
Jan 12, 2018
Start date
Nov 16, 2017
Primary completion
Jan 16, 2018
Completion
Jan 16, 2018
Last update
Feb 21, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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