An Open-label Extension Study of an Investigational Drug, ALN-AT3SC, in Patients With Moderate or Severe Hemophilia A or B
Status: | Active, not recruiting |
---|---|
Conditions: | Anemia, Hematology |
Therapuetic Areas: | Hematology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 8/12/2018 |
Start Date: | September 18, 2015 |
End Date: | September 2021 |
An Open-label Extension Study of Subcutaneously Administered ALN-AT3SC in Patients With Moderate or Severe Hemophilia A or B Who Have Participated in a Previous Clinical Study With ALN-AT3SC
The purpose of this study is to evaluate the long-term safety and tolerability of ALN-AT3SC
in male patients with moderate or severe hemophilia A or B.
in male patients with moderate or severe hemophilia A or B.
Inclusion Criteria:
- Completed and tolerated study drug dosing in study TDR14767 (ALN-AT3SC-001)
- Male aged ≥18 years
- Moderate or severe, clinically stable hemophilia A or B
- Willing and able to comply with the study requirements and provide written informed
consent
Exclusion Criteria:
- Clinically significant liver disease
- Patients known to be human immunodeficiency virus seropositive and have a CD4 count
<200 cells/μL
- History of venous thromboembolism
- Current serious mental illness that, in the judgment of the Investigator, may
compromise patient safety, ability to participate in all study assessments, or study
integrity
- Clinically relevant history or presence of cardiovascular, respiratory,
gastrointestinal, renal, neurological, inflammatory, or other diseases that, in the
judgment of the Investigator, precludes study participation
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