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

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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.


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
We found this trial at
3
sites
Pittsburgh, Pennsylvania
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Pittsburgh, PA
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Ann Arbor, Michigan 48109
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Ann Arbor, MI
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Plovdiv,
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