First-in-Human and Proof-of-Mechanism Study of ARC19499 Administered to Hemophilia Patients

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01191372
First received: August 26, 2010
Last updated: April 5, 2013
Last verified: April 2013

August 26, 2010
April 5, 2013
September 2010
December 2011   (final data collection date for primary outcome measure)
Pharmacokinetics (PK) of ARC19499 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
The PK profile of ARC19499 administered by single and multiple subcutaneous injections will be characterized. The bioavailability of subcutaneously injected ARC19499 relative to that of intravenously infused ARC19499 will be determined.
Pharmacokinetics of ARC19499 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
The PK profile of ARC19499 administered by single and multiple subcutaneous injections will be characterized. The bioavailability of subcutaneously injected ARC19499 relative to that of intravenously infused ARC19499 will be determined.
Complete list of historical versions of study NCT01191372 on ClinicalTrials.gov Archive Site
Coagulation system pharmacodynamic (PD) effects of ARC19499. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
The PD profile of ARC19499 with respect to the kinetics of thrombin generation and clot formation will be characterized.
Coagulation system pharmacodynamic effects of ARC19499. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
The PD profile of ARC19499 with respect to the kinetics of thrombin generation and clot formation will be characterized.
Not Provided
Not Provided
 
First-in-Human and Proof-of-Mechanism Study of ARC19499 Administered to Hemophilia Patients
First-in-Human and Proof-of-Mechanism Study of ARC19499 Administered to Hemophilia Patients

The purpose of this study is to examine the safety, tolerability and the way the body handles various single and multiple doses of ARC19499 in patients with hemophilia.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hemophilia
  • Drug: placebo control
    sterile saline for injection
  • Drug: ARC19499
    Anti-tissue factor pathway inhibitor (TFPI) aptamer
  • Placebo Comparator: saline for injection
    Intervention: Drug: placebo control
  • Experimental: ARC19499 Low Dose
    Intervention: Drug: ARC19499
  • Experimental: ARC19499 Mid Dose
    Intervention: Drug: ARC19499
  • Experimental: ARC19499 High Dose
    Intervention: Drug: ARC19499
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
17
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

Adult male patients ≥18 to ≤75 years of age.

  • Hemophilia of any type or severity.
  • Patients who are negative for hepatitis B surface antigen (HBsAg), and human immunodeficiency virus (HIV) I and II antibody tests at screening.
  • Male patients who, with their partners, are willing to use 2 effective, methods of contraception (i.e., for both self and partner) throughout the study and for at least 3 months after discontinuation of study drug treatment.
  • All patients must be capable of understanding and complying with the protocol and must have signed the informed consent document.

Exclusion Criteria:

  • Female patients;
  • If on a prophylactic coagulation factor concentrate regimen, inability or unwillingness to discontinue prophylaxis during participation in this study.
  • Existence of other co-existing bleeding disorder (e.g., von Willebrand Disease).
  • Medical history of venous or arterial thromboembolism.
  • Scheduled for elective surgical procedure during the conduct of this study.
  • Use of an investigational drug within 30 days of study entry.
  • Transaminase values > 3 x upper limit of normal (ULN) at time of screening.
  • Haemoglobin <12.0 g/dL.
  • Participants who, in the opinion of the Investigator, have a significant infection or known inflammatory process on screening.
  • Participants who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders.
  • Any medical condition the investigator believes would place the patient at increased risk as a result of participation in the study e.g. history of thromboembolic disease or stroke.
  • Any medication the investigator considers may increase the risk of adverse effects during the study.
Male
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01191372
ARC19499-001, 2010-020373-17, 271101
No
Baxter Healthcare Corporation
Baxter Healthcare Corporation
Not Provided
Study Director: Wing-Yen Wong, MD Baxter Healthcare Corporation
Baxter Healthcare Corporation
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP