Status:
TERMINATED
First-in-Human and Proof-of-Mechanism Study of ARC19499 Administered to Hemophilia Patients
Lead Sponsor:
Baxalta now part of Shire
Conditions:
Hemophilia
Eligibility:
MALE
18-75 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 15 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2011
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01191372
Start Date
September 15 2010
End Date
December 28 2011
Last Update
May 5 2021
Active Locations (1)
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1
London, United Kingdom