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NCT00879034 · ClinicalTrials.gov registry record · Phase 2
A Study of Zoledronic Acid, Pravastatin, and Lonafarnib for Patients With Progeria
A Phase 2 study, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT00879034 is a Phase 2 study that has completed, run by Boston Children's Hospital. The registered enrollment target is 5 participants.
The verdict
NCT00879034, a Phase 2 study, has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
This is an open label single arm feasibility trial. A combination of two oral agents (pravastatin and lonafarnib) and one intravenous (IV) agent (zoledronic acid) will be administered at doses and schedule currently applied in pediatrics. These agents all target farnesylation pathways at different points. Our goal is to inhibit farnesylation of abnormal lamin, the disease-causing protein in Hutchinson-Gilford Progeria Syndrome and progeroid laminopathies (henceforth "progeria"). The drugs will include the intravenous bisphosphonate zoledronic acid, oral HMG co-reductase inhibitor pravastatin and the oral farnesyltransferase inhibitor (FTI) lonafarnib (SCH 66336). Patients with genetically confirmed progeria will be eligible for this protocol. Treatment will be initiated for 4 weeks duration and may be extended depending on tolerability. This study will assess the feasibility of this treatment regimen in the first 4 weeks. If tolerated for 4 weeks, patients can be treated with this regimen for up to 6 months.
Interventions
- DRUG Pravastatin
- DRUG Zoledronic Acid
- DRUG Lonafarnib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2009-03 |
| Est. Completion | 2009-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00879034
The ClinicalTrials.gov registry entry for NCT00879034 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Pravastatin is the first listed.
NCT00879034 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00879034 about?
NCT00879034 is a clinical study titled "A Study of Zoledronic Acid, Pravastatin, and Lonafarnib for Patients With Progeria". This is an open label single arm feasibility trial. A combination of two oral agents (pravastatin and lonafarnib) and one intravenous (IV) agent (zoledronic acid) will be administered at doses and schedule currently applied in pediatrics. These agents all target farnesylation pathways at different p...
What is the current status of trial NCT00879034?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2009-03. Estimated completion is 2009-04.
What interventions are being tested in trial NCT00879034?
The interventions under investigation include: Pravastatin (DRUG), Zoledronic Acid (DRUG), Lonafarnib (DRUG).
Who is sponsoring clinical trial NCT00879034?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
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