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

Hemophilia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01191372
• Other study ID #: ARC19499-001
• Secondary ID: 2010-020373-1727
• Status: Terminated
• Phase: Phase 1
• Start date: September 15, 2010
• Est. completion date: December 28, 2011

Study information

• Verified date: May 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: December 28, 2011
• Est. primary completion date: December 28, 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemophilia
• Hemophilia A

Intervention

Drug:
• placebo control
sterile saline for injection
• ARC19499
Anti-tissue factor pathway inhibitor (TFPI) aptamer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Baxalta now part of Shire

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK) of ARC19499	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.	2 weeks
Secondary	Coagulation system pharmacodynamic (PD) effects of ARC19499.	The PD profile of ARC19499 with respect to the kinetics of thrombin generation and clot formation will be characterized.	2 weeks