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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: Completed Phase 2 study, sponsored by Boston Children's Hospital.

NCT00879034 is a Phase 2 study that has completed, run by Boston Children's Hospital. The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Feasibility was assessed by determining the number of participants with adverse events occurring over the course of the 4 week study.

Interventions

  • DRUG Pravastatin
  • DRUG Zoledronic Acid
  • DRUG Lonafarnib

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2009-03
Est. Completion 2009-04
Phase Phase 2
Boston Children's Hospital

462 total trials

What the finished NCT00879034 record still lists

NCT00879034 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 3 interventions - of which Pravastatin is the first listed.

NCT00879034 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00879034's enrollment target sits among peer trials

5 2000th of 2000 the lowest of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00879034, the US trial registry maintained by the National Library of Medicine. NCT00879034 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.