A phase 1 clinical trial of ABI-009 an mTOR inhibitor for patients with severe pulmonary arterial hypertension (PAH)
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- STATUS
- Not Recruiting
Summary
The purpose of this study is to look at the safety and effects of ABI-009, an investigational drug that has not yet been approved by the Food and Drug Administration on patients with severe pulmonary artery hypertension.
Description
The significance of this study is that it offers a new approach to the treatment of debilitating PAH by targeting the disease biology, i.e. proliferation of cells. This is a phase 1 prospective, open label, single arm dose finding study to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), safety and preliminary efficacy of ABI-009 given intravenously to subjects with severe WHO Group 1 pulmonary arterial hypertension who are WHO Functional Class 3 in spite of treatment with 2 or more background PAH therapies.
Details
| Condition | severe pulmonary arterial hypertension |
|---|---|
| Age | 18years - 100years |
| Clinical Study Identifier | TX8809 |
| Last Modified on | 23 September 2024 |
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