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NCT00409175 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study of Fx-1006A in Patients With Familial Amyloidosis
A Phase 2 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 128
- Enrollment target
NCT00409175 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 128 participants.
The verdict
NCT00409175, a Phase 2 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 128 participants
- Enrollment target
Study Summary
This study will examine whether Fx-1006A is effective in halting the progression of Familial Amyloid Polyneuropathy (FAP). Deposition of TTR amyloid is associated with a variety of human diseases. Deposition of amyloid fibrils of variant TTR (primarily V30M) in peripheral nerve tissue produces the condition called FAP. The prevention of the formation of amyloid by stabilization of the TTR native state should constitute an effective therapy for amyloid diseases. Therapeutic intervention with a TTR stabilizer drug, such as Fx-1006A, is hypothesized to stop progression of the disease in FAP patients. FAP is a uniformly fatal disease and Fx-1006A is intended to halt the relentless neurological deterioration FAP patients experience. This Phase 2/3 study will enroll early to mid-stage FAP patients in order to interrupt and stabilize the disease at a point in time where progression of motor and autonomic dysfunction can be maximally effected. Male and female patients with FAP with documented V30M TTR mutation will receive Fx-1006A or placebo once daily for a period of eighteen (18) months.
Interventions
- DRUG Placebo
- DRUG Fx-1006A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2007-01 |
| Est. Completion | 2009-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00409175
The ClinicalTrials.gov registry entry for NCT00409175 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 128 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00409175 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00409175 about?
NCT00409175 is a clinical study titled "Safety and Efficacy Study of Fx-1006A in Patients With Familial Amyloidosis". This study will examine whether Fx-1006A is effective in halting the progression of Familial Amyloid Polyneuropathy (FAP). Deposition of TTR amyloid is associated with a variety of human diseases. Deposition of amyloid fibrils of variant TTR (primarily V30M) in peripheral nerve tissue produces the ...
What is the current status of trial NCT00409175?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 128 participants. The study started on 2007-01. Estimated completion is 2009-05.
What interventions are being tested in trial NCT00409175?
The interventions under investigation include: Placebo (DRUG), Fx-1006A (DRUG).
Who is sponsoring clinical trial NCT00409175?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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