Brief Title
First-in-Human and Proof-of-Mechanism Study of ARC19499 Administered to Hemophilia Patients
Official Title
First-in-Human and Proof-of-Mechanism Study of ARC19499 Administered to Hemophilia Patients
Brief 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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Pharmacokinetics (PK) of ARC19499
Secondary Outcome
Coagulation system pharmacodynamic (PD) effects of ARC19499.
Condition
Hemophilia
Intervention
placebo control
Study Arms / Comparison Groups
saline for injection
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
17
Start Date
September 15, 2010
Completion Date
December 28, 2011
Primary Completion Date
December 28, 2011
Eligibility Criteria
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.
Gender
Male
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Study Director, ,
Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT01191372
Organization ID
ARC19499-001
Secondary IDs
2010-020373-17
Responsible Party
Sponsor
Study Sponsor
Baxalta now part of Shire
Study Sponsor
Study Director, Study Director, Takeda
Verification Date
May 2021