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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03275740
Registration number
NCT03275740
Ethics application status
Date submitted
6/07/2017
Date registered
8/09/2017
Date last updated
31/05/2023
Titles & IDs
Public title
A First in HumanTrial to Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-06755347
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Scientific title
A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO -CONTROLLED, FIRST-IN-HUMAN TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF PF 06755347 AFTER SINGLE ASCENDING INTRAVENOUS AND SUBCUTANEOUS DOSING IN HEALTHY ADULT MALE PARTICIPANTS AND OPEN-LABEL AFTER SINGLE SUBCUTANEOUS DOSING IN MALE AND FEMALE PARTICIPANTS WITH PERSISTENT OR CHRONIC PRIMARY IMMUNE THROMBOCYTOPENIA
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Secondary ID [1]
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2018-003315-21
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Secondary ID [2]
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B7801001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Healthy
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Primary Immune Thrombocytopenia
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Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
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Condition category
Condition code
Neurological
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Other neurological disorders
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Neurological
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Neurodegenerative diseases
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Inflammatory and Immune System
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Autoimmune diseases
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Blood
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Haematological diseases
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Blood
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Other blood disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - PF-06755347 intravenous healthy participant
Treatment: Drugs - Placebo intravenous healthy participant
Treatment: Drugs - PF-06755347 subcutaneous healthy participant
Treatment: Drugs - Placebo subcutaneous healthy participant
Treatment: Drugs - PF-06755347 subcutaneous ITP
Experimental: PF-06755347 intravenous healthy participant - intravenous administration
Placebo Comparator: Placebo intravenous healthy participant - intravenous administration
Experimental: PF-06755347 subcutaneous healthy participant - subcutaneous administration
Placebo Comparator: Placebo subcutaneous healthy participant - subcutaneous administration
Experimental: PF-06755347 subcutaneous ITP - subcutaneous
Treatment: Drugs: PF-06755347 intravenous healthy participant
Single doses of PF-06755347 will be administered intravenously dose levels 1, 2, 3, 4, 5, and 6.
Treatment: Drugs: Placebo intravenous healthy participant
Placebo comparator
Treatment: Drugs: PF-06755347 subcutaneous healthy participant
single doses of PF-06755347 will be administered subcutaneously at dose levels of SC1, SC2, SC3, SC4, and SC5.
Treatment: Drugs: Placebo subcutaneous healthy participant
placebo comparator
Treatment: Drugs: PF-06755347 subcutaneous ITP
single doses of PF-06755347 will be administered subcutaneously at 2 dose levels tested in healthy participants
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
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Assessment method [1]
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Timepoint [1]
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Baseline (study day -2) through study completion (study day 36 for intravenous dose cohorts 1 - 6, and study day 71 for subcutaneous dose cohorts.
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Primary outcome [2]
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Number of Participants With Clinical Laboratory Abnormalities
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Assessment method [2]
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Safety laboratory includes Hematology, Chemistry, Urinalysis, prothrombin time/international normalized ratio, partial thromboplastin time, D dimer, and fibrinogen
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Timepoint [2]
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Baseline, study days 1, 2, 4, 6, 8, 11, 15, 22, 29 and 36 for i.v. dose cohorts 1 - 6, and Baseline, study days 1, 2, 3, 4, 6, 8, 11, 15, 22, 29, 36, 50 and day 71 for subcutaneous dose cohorts.
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Primary outcome [3]
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Number of Participants With Categorical Vital Signs Data
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Assessment method [3]
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Vital signs include blood pressure, pulse rate, and body temperature. Number of participants with maximum increase from Baseline in sitting SBP and DBP of greater than or equal to 30 mmHg will be reported
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Timepoint [3]
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Baseline, study days 1, 2, 3, 4, 6, 8, 11, 15, 22, 29, and day 36 for i.v. dose cohorts 1 - 6 and Baseline, study days 1, 2, 3, 4, 6, 8, 11, 15, 22, 29, 36, 50 and day 71 for subcutaneous dose cohorts.
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Primary outcome [4]
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Number of Participants With Abnormal Electrocardiogram (ECG)
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Assessment method [4]
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Criteria for ECG abnormalities: maximum PR interval >=300 milliseconds (msec) and maximum increase PR interval increase from baseline (IFB): percent change (Pctchg) >=25 percent (%) for baseline value of >200 msec and Pctchg>=50% for baseline value of <=200 msec for PR interval, maximum QRS interval >=140 msec and a maximum IFB: Pctchg>=50%, maximum QTCF interval (Fridericia's Correction) of 450 msec to <480 msec, 480 msec to <500 msec or >=500 msec and a maximum change of <=30change<60 or >=60 msec from baseline.
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Timepoint [4]
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Baseline (study day 1, pre-dose), study days 1 (post dose), 2, 4, 6, 8, 11, 22, 36 (end of study visit for intravenous dose cohorts 1 - 6, and end of study visit day 71) for subcutaneous dose cohorts.
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Secondary outcome [1]
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Maximum Observed Plasma Concentration (Cmax)
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Assessment method [1]
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Timepoint [1]
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Hours 0, 12, 24, 48, 72, 120, 168 for all cohorts. Hours 1, 3, 5, & 8 for all i.v. cohorts. Hour 36 for i.v. cohorts 1-2. Days 15, 22, 29, and 36 for subcutaneous and i.v. cohorts 5 exp & 6. Days 5, 11, 50 & 71 for subcutaneous cohorts
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Secondary outcome [2]
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Dose Normalized Maximum Observed Plasma Concentration Cmax
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Assessment method [2]
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Timepoint [2]
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Hours 0, 12, 24, 48, 72, 120, 168 for all cohorts. Hours 1, 3, 5, & 8 for all i.v. cohorts. Hour 36 for i.v. cohorts 1-2. Days 15, 22, 29, and 36 for subcutaneous and i.v. cohorts 5 exp & 6. Days 5, 11, 50 & 71 for subcutaneous cohorts
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Secondary outcome [3]
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Time to Reach Maximum Observed Plasma Concentration (Tmax)
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Assessment method [3]
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Timepoint [3]
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Hours 0, 12, 24, 48, 72, 120, 168 for all cohorts. Hours 1, 3, 5, & 8 for all i.v. cohorts. Hour 36 for i.v. cohorts 1-2. Days 15, 22, 29, and 36 for subcutaneous and i.v. cohorts 5 exp & 6. Days 5, 11, 50 & 71 for subcutaneous cohorts
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Secondary outcome [4]
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
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Assessment method [4]
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Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
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Timepoint [4]
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Hours 0, 12, 24, 48, 72, 120, 168 for all cohorts. Hours 1, 3, 5, & 8 for all i.v. cohorts. Hour 36 for i.v. cohorts 1-2. Days 15, 22, 29, and 36 for subcutaneous and i.v. cohorts 5 exp & 6. Days 5, 11, 50 & 71 for subcutaneous cohorts
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Secondary outcome [5]
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Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
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Assessment method [5]
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Timepoint [5]
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Hours 0, 12, 24, 48, 72, 120, 168 for all cohorts. Hours 1, 3, 5, & 8 for all i.v. cohorts. Hour 36 for i.v. cohorts 1-2. Days 15, 22, 29, and 36 for subcutaneous and i.v. cohorts 5 exp & 6. Days 5, 11, 50 & 71 for subcutaneous cohorts
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Secondary outcome [6]
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Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
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Assessment method [6]
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AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
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Timepoint [6]
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Hours 0, 12, 24, 48, 72, 120, 168 for all cohorts. Hours 1, 3, 5, & 8 for all i.v. cohorts. Hour 36 for i.v. cohorts 1-2. Days 15, 22, 29, and 36 for subcutaneous and i.v. cohorts 5 exp & 6. Days 5, 11, 50 & 71 for subcutaneous cohorts
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Secondary outcome [7]
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Dose Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
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Assessment method [7]
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Timepoint [7]
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Hours 0, 12, 24, 48, 72, 120, 168 for all cohorts. Hours 1, 3, 5, & 8 for all i.v. cohorts. Hour 36 for i.v. cohorts 1-2. Days 15, 22, 29, and 36 for subcutaneous and i.v. cohorts 5 exp & 6. Days 5, 11, 50 & 71 for subcutaneous cohorts
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Secondary outcome [8]
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Plasma Decay Half-Life (t1/2)
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Assessment method [8]
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Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
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Timepoint [8]
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Hours 0, 12, 24, 48, 72, 120, 168 for all cohorts. Hours 1, 3, 5, & 8 for all i.v. cohorts. Hour 36 for i.v. cohorts 1-2. Days 15, 22, 29, and 36 for subcutaneous and i.v. cohorts 5 exp & 6. Days 5, 11, 50 & 71 for subcutaneous cohorts
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Secondary outcome [9]
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Apparent Clearance (CL)
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Assessment method [9]
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Steady state total body clearance equals infusion rate (zero order) divided by steady state plasma concentration of study drug (R0/Css)
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Timepoint [9]
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Hours 0, 12, 24, 48, 72, 120, 168 for all cohorts. Hours 1, 3, 5, & 8 for all i.v. cohorts. Hour 36 for i.v. cohorts 1-2. Days 15, 22, 29, and 36 for subcutaneous and i.v. cohorts 5 exp & 6. Days 5, 11, 50 & 71 for subcutaneous cohorts
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Secondary outcome [10]
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Incidence of Anti-Drug Antibody (ADA)
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Assessment method [10]
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Timepoint [10]
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Baseline, study days 8, 15, and 36 for all dose cohorts plus day 71 for subcu cohorts
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Secondary outcome [11]
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Characterization of biomarker changes
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Assessment method [11]
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Timepoint [11]
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Day -1, hours 0, 5, 12, 24, 48, 72 for all cohorts. Hours 1 (or end of infusion, 8, 120 and days 11 & 29 for i.v. cohorts Days 5, 8, 15, 36 & 71 for subcutaneous cohorts.
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Eligibility
Key inclusion criteria
Inclusion Criteria Healthy male participants:
- at the time of screening, are between the ages of 18 and 55 years, inclusive. Healthy
is defined as no clinically relevant abnormalities identified by a detailed medical
history, full physical examination, including oral temperature, blood pressure (BP)
and pulse rate measurement, pulse oximetry, 12 lead ECG or clinical laboratory tests.
- Evidence of a personally signed and dated informed consent document indicating that
the subject has been informed of all pertinent aspects of the study.
- Chest X ray with no evidence of current, active tuberculosis (TB) or previous inactive
TB, general infections, heart failure, malignancy, or other clinically significant
abnormalities taken at Screening or within 3 months prior to Screening and read by a
qualified radiologist.
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Exclusion Criteria for Healthy male participants:
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at the time of dosing).
- Participants with a history of autoimmune disorders and other conditions that
compromise or impair the immune system (including but not limited to: Crohns Disease,
rheumatoid arthritis, scleroderma, systemic lupus erythematosus, Graves disease, and
asthma) or have a current positive result for the following; rheumatoid factor,
anti-nuclear antibody, or abnormal free triiodothyronine (T3), free thyroxine (T4),
thyroid stimulating hormone (TSH), or thyroid stimulating antibody (TSAb) suggestive
of thyroid disease.
- Subjects with a history of allergic or anaphylactic reaction to any drug including
immunoglobulin.
- History of active infections within 28 days prior to the screening visit.
- Subjects with a history of or current positive results for any of the following
serological tests: Hepatitis B surface antigen (HepBsAg), Hepatitis B core antibody
(HepBcAb), Hepatitis C antibody (HCVAb) or human immunodeficiency virus (HIV).
- Subjects with a history of thromboembolic events.
- History of TB or active, latent or inadequately treated TB infection. All positive TB
test result(s) are exclusionary
- Male subjects with partners currently pregnant; male subjects able to father children
who are unwilling or unable to use a highly effective method of contraception as
outlined in this protocol for the duration of the study.
- Inclusion Criteria for ITP participants:
Female participants may be of childbearing potential or non-childbearing potential.
-Diagnosis of Primary ITP. ITP must be diagnosed in accordance with established guidelines.
ITP duration-Persistent (>3 months and =12 months) OR Chronic (>12 months).
AND
- Platelet count 30-75 x 10E9/L (inclusive) with criteria achieved on 2 qualifying
counts at least 5 days apart and within approx. 10 days of dosing
- Participants must have received and responded to IVIg or corticosteroids as treatment
for ITP (response is defined as achievement of platelet count >50 x 109/L and doubling
of platelet count from baseline).
--Evidence of a personally signed and dated informed consent document indicating that
the subject has been informed of all pertinent aspects of the study.
- BMI of 17.5 to 30.5 kg/m2 and a total body weight >40 kg (88 lbs).
Exclusion Criteria for ITP participants
- History of clinically significant hematological (other than ITP), renal, endocrine,
metabolic, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric,
neurologic, or allergic disease (but excluding untreated, asymptomatic, seasonal
allergies at the time of dosing).
- Chest X-ray with evidence of current, active TB, previous inactive TB, general
infections, heart failure, malignancy, or other clinically significant abnormalities.
Chest x-ray must be taken at Screening or within 3 months prior to Screening and read by a
qualified radiologist.
- Any bleeding event requiring medical evaluation or treatment in the 4 weeks prior to
screening or current bleeding event that requires treatment.
- Scheduled or anticipated invasive procedures (eg, surgery, dental procedures) within
28 days following PF-06755347 dosing.
- Splenectomy within =180 days prior to PF-06755347 dosing or splenectomy planned during
the period of the study.
- History of any active autoimmune disorder (other than ITP) or other conditions that
may compromise or impair the immune system (including but not limited to: Crohn's
Disease, rheumatoid arthritis, scleroderma, systemic lupus erythematosus, Graves'
disease, and asthma).
- History of allergic or anaphylactic reaction to any drug including immunoglobulin.
- History of active infections within 28 days prior to the screening visit.
- History of Hepatitis B, Hepatitis C or HIV or current positive results for any of the
following serological tests - HBsAg, HBcAb, HCVAb or HIV.
- History of thromboembolic events
- Hemoglobin <9 g/dL.
- Positive Direct Coombs test
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
17/07/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
6/01/2023
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Sample size
Target
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Accrual to date
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Final
58
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Connecticut
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Country [2]
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Belgium
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State/province [2]
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Brussels
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Country [3]
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New Zealand
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State/province [3]
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Christchurch
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Country [4]
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Spain
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State/province [4]
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Madrid
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Country [5]
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Spain
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State/province [5]
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Sevilla
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Country [6]
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United Kingdom
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State/province [6]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This phase 1 single ascending dose study will provide a first in human assessment of safety
and tolerability of PF-06755347 in healthy adult males as well as adult males and females
with Immune Thrombocytopenia (ITP). Pharmacokinetics and pharmacodynamics will also be
evaluated.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03275740
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03275740
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