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ALN-TTR02 administered by infusion · 1 trial · 1 indication
An AE is any untoward medical occurrence in a patient or clinical investigational patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
| Arm | Type | Description |
|---|---|---|
| ALN-TTR02 (patisiran) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ALN-TTR02 (patisiran) administered by intravenous (IV) infusion | DRUG | - |
Inclusion Criteria: * Previously received and tolerated ALN-TTR02 (patisiran) in Study ALN-TTR02-002. * Adequate Karnofsky performance status, liver function, and renal function. Exclusion Criteria: * Pregnant or nursing. * Has had a liver transplant. * Has a New York Heart Association heart fail...
ALN-TTR02 is being developed for the treatment of transthyretin (TTR)-mediated amyloidosis, a rare disease in which abnormal TTR protein deposits damage tissues and organs. It is an RNA therapy given by intravenous infusion. The clinical program studied it in patients who had already received ALN-TTR02.
ALN-TTR02 is being developed by Alnylam Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker ALNY. The company ran the Phase 2 study of the drug in patients with TTR-mediated amyloidosis across sites in the United States, Brazil, France, Germany, Portugal, Spain, and Sweden.
ALN-TTR02 is in Phase 2 development. It is an investigational RNA therapy and has not been approved by the FDA. One Phase 2 trial, NCT01961921, has been completed, and no trials of the drug are currently active. The completed study enrolled 27 patients.
ALN-TTR02 was evaluated in the Phase 2 trial NCT01961921, titled a study of ALN-TTR02 (patisiran) for the treatment of transthyretin (TTR)-mediated amyloidosis in patients who had already been treated with ALN-TTR02. The trial is completed, enrolled 27 patients aged 18 years and older, and was conducted in seven countries.
Yes. ALN-TTR02 is also known as patisiran, and the intravenous infusion form is referred to as ALN-TTR02 (patisiran) administered by intravenous (IV) infusion. The Phase 2 trial NCT01961921 lists the drug under both the ALN-TTR02 and patisiran names.
The Phase 2 trial NCT01961921 was an uncontrolled, open-label study, not randomized and not double-blind. It enrolled 27 patients with TTR-mediated amyloidosis who had already been treated with ALN-TTR02, with participants aged 18 years and older of any sex. Healthy volunteers were not included.