Study of Zoledronic Acid, Pravastatin, and Lonafarnib for Patients With Progeria

PHASE2UnknownINTERVENTIONAL
Enrollment

85

Participants

Timeline

Start Date

August 31, 2009

Primary Completion Date

February 28, 2022

Study Completion Date

December 31, 2023

Conditions
Progeria
Interventions
DRUG

Lonafarnib, Zoledronic Acid, and Pravastatin

"Lonafarnib: Lonafarnib dosing will begin at 150 mg/m2 by mouth twice daily. Lonafarnib will be orally administered without planned breaks, approximately every 12 hours, for a period of 24 months. For patients unable to swallow capsules, the capsules can be opened and dissolved into Ora Blend SF or Ora-Plus.~Zoledronic Acid: Zoledronic acid will be administered intravenously at week one, and months 6, 12, 18 and 24 of this treatment trial. Treatment will consist of one infusion over a 30 minute period.~Pravastatin: Pravastatin will be orally administered once daily without planned breaks, approximately every 24 hours, for a period of 24 months. The drug may be taken with meals. For patients unable to swallow pills, pills can be crushed into food. Pravastatin will be dosed according to the patient weight. Patients less than 10 kg will receive 5 mg pravastatin orally, once daily. Patients weighing 10 kg or greater will receive 10 mg pravastatin daily."

Trial Locations (1)

02115

Children's Hospital Boston, Boston

All Listed Sponsors
collaborator

Schering-Plough

INDUSTRY

collaborator

Merck Sharp & Dohme LLC

INDUSTRY

collaborator

Eiger BioPharmaceuticals

INDUSTRY

lead

Boston Children's Hospital

OTHER