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Trial record 18 of 80967 for:    measured

Phase 2 Study of Apixaban Reversal by Ciraparantag as Measured by WBCT

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ClinicalTrials.gov Identifier: NCT03288454
Recruitment Status : Recruiting
First Posted : September 20, 2017
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Perosphere, Inc.

Brief Summary:
This study is a randomized, single-blind, placebo-controlled study to assess the efficacy and safety of ciraparantag administered to healthy volunteers anticoagulated with apixaban measuring clotting times using Whole Blood Clotting Time (WBCT).

Condition or disease Intervention/treatment Phase
Healthy Drug: Ciraparantag Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Phase 2 Placebo-Controlled, Single-Site, Single-Blind Study of Apixaban Reversal by Ciraparantag as Measured by WBCT
Actual Study Start Date : September 10, 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Apixaban

Arm Intervention/treatment
Experimental: Cohort 1
Administer ciraparantag or placebo Dosing schedule 1
Drug: Ciraparantag
Reversal of riva apixaban-induced anticoagulation via dose of ciraparantag or placebo
Other Name: PER977

Drug: Placebo
Reversal of riva apixaban-induced anticoagulation via dose of ciraparantag or placebo

Experimental: Cohort 2
Administer ciraparantag or placebo Dosing schedule 2
Drug: Ciraparantag
Reversal of riva apixaban-induced anticoagulation via dose of ciraparantag or placebo
Other Name: PER977

Drug: Placebo
Reversal of riva apixaban-induced anticoagulation via dose of ciraparantag or placebo

Experimental: Cohort 3
Administer ciraparantag or placebo Dosing schedule 3
Drug: Ciraparantag
Reversal of riva apixaban-induced anticoagulation via dose of ciraparantag or placebo
Other Name: PER977

Drug: Placebo
Reversal of riva apixaban-induced anticoagulation via dose of ciraparantag or placebo




Primary Outcome Measures :
  1. efficacy of ciraparantag in the reversal of anticoagulation induced by apixaban measured by WBCT [ Time Frame: 4 days ]
    efficacy of ciraparantag in the reversal of anticoagulation induced by apixaban at steady state measured by WBCT.


Secondary Outcome Measures :
  1. Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment [ Time Frame: 10 days ]
    Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Adults age 50 to 75 years, inclusive
  2. Laboratory tests (chemistry, hematology and coagulation assessments) and urinalysis performed during screening up to 36 days prior to administration of study treatment deemed not clinically significant by the principal investigator.
  3. No clinically significant findings on 12-lead electrocardiogram (ECG) performed during screening
  4. Body mass index (BMI) 18 to ≤ 32 kg/m2, inclusive
  5. Male subjects agree to use appropriate contraception (i.e., latex condom with spermicide) in addition to their partner using an acceptable form of contraception (e.g., diaphragm, cervical cap, intrauterine device, hormonal contraceptives, surgical sterilization or post-menopausal), when engaging in sexual activity during the course of the study. Moreover, male subjects should not donate sperm or attempt to impregnate a partner during the course of the study and for a period of 12 weeks following discharge from the study.
  6. Female subjects must have a negative urine pregnancy test at screening AND: be surgically sterile (with documentation of hysterectomy, bilateral oophorectomy, bilateral salpingectomy, bilateral tubal ligation/tubal occlusion) OR post-menopausal (no menstruation for a minimum of 12 months and confirmed by follicle stimulating hormone [FSH] of ≥ 40 mIU/ml) OR, if of child-bearing potential, must be using an acceptable method of contraception such as an IUD, implant or contraceptive injection, or two forms of the following (e.g., diaphragm, cervical cap, oral, patch or vaginal hormonal contraceptive, condom, spermicide, or sponge) for the last three months, OR in a monogamous relation with a male partner who has undergone a documented vasectomy a minimum of 6 months prior to study commencement. All females must agree to continue to use their method of birth control for the duration of the study and for a minimum of one complete menstrual cycle or 28 days following discharge from the study Ciraparantag Perosphere Inc. Clinical Trial Protocol: PER977-02-011 9 August 2017 Confidential Page 10 of 85
  7. Subjects who have participated in a prior study of ciraparantag must have been discharged from the study a minimum of 1 month prior to the planned treatment.
  8. Subjects must understand and agree to comply with the requirements of the study and they must be willing to sign the informed consent form indicating voluntary consent to participate in the study prior to initiation of screening or study-related activities -

Exclusion Criteria:

  1. History or current evidence of clinically significant cardiac, hepatic, renal, pulmonary, endocrine, neurologic, infectious, gastrointestinal (including gallbladder disease or surgery), hematologic, or oncologic disease as determined by screening history, physical examination, laboratory test results or 12-lead ECG assessment. History or current evidence of liver function tests greater than 50% of the upper limit of normal (ULN) or renal function tests (serum creatinine) greater than 1.5 mg/dl and based on PI discretion. History or current evidence of QTc (QTcF) greater than normal (450 msec for males or 470 msec for females).
  2. History of unexplained syncope
  3. History of major bleeding, trauma, or surgical procedure of any type,
  4. Vaginal delivery within six months prior to screening
  5. History of peptic ulcer, gastrointestinal bleeding (including hematemesis, melena, rectal bleeding) within one year prior to screening
  6. Long standing history of bleeding episodes such as epistaxis, bruising or gingival bleeding or if not long standing, within 1 month prior to screening
  7. Personal or family history of clotting disorder or abnormality, excessive bleeding, joint hematoma, thrombovascular disease or any hematologic disorder involving platelets or clotting abnormalities or any condition requiring treatment with transfusions, or history of thrombocytopenia
  8. Females with a history of dysfunctional uterine bleeding who have not undergone hysterectomy, including history of menorrhagia (heavy menstrual bleeding), menometrorrhagia or polymenorrhea
  9. Smokers or use of tobacco and/or nicotine containing products within 3 months prior to dosing as determined by the subject's verbal history
  10. Pregnant or breast-feeding
  11. Males with a history of hormone therapy within 3 months prior to screening
  12. Taking any type of chronic medication (including vitamin, nutritional and herbal supplements) for more than 14 consecutive days within the 4 weeks prior to study entry (use of hormonal contraceptives is acceptable except for oral contraceptives)
  13. Positive serologic test for human immunodeficiency virus (HIV), Hepatitis C virus antibody (HCV-Ab), or Hepatitis B surface antigen (HBsAg)
  14. Donation of blood or blood products within 56 days prior to screening
  15. Participation in any study with an investigational compound or device within 30 days prior to signing informed consent
  16. Active drug or alcohol dependence within the prior 12 months or any condition that, in the opinion of the Investigator, would interfere with adherence to study protocol
  17. Allergic to apixaban

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03288454


Contacts
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Contact: Solomon S Steiner, PhD 203 885 1116 s.steiner@perosphere.com
Contact: Barry H Ginsberg, MD, PhE 203 885 1111 b.ginsberg@perosphere.com

Locations
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United States, New Jersey
Frontage Clinical Services Inc. Recruiting
Secaucus, New Jersey, United States, 07094
Contact: Alexander N. Prezioso, MD    201-416-7747    aprezioso@frontaglab.com   
Principal Investigator: Alexander N Prezioso, MD         
Sponsors and Collaborators
Perosphere, Inc.

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Responsible Party: Perosphere, Inc.
ClinicalTrials.gov Identifier: NCT03288454     History of Changes
Other Study ID Numbers: PER977-02-011
First Posted: September 20, 2017    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Perosphere, Inc.:
Ciraparantag
PER977
Apixaban
Whole Blood Clotting Time (WBCT)
Additional relevant MeSH terms:
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Apixaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants