Long-Term Safety Follow-up Study of Cysteamine Bitartrate Delayed-release Capsules (RP103)

PHASE3CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

August 27, 2010

Primary Completion Date

June 26, 2017

Study Completion Date

June 26, 2017

Conditions
Cystinosis
Interventions
DRUG

Cysteamine Bitartrate Delayed-release Capsules

"Participants who entered the trial from the RP103-03 study continued treatment with cysteamine bitartrate every 12 hours at the last dose level prescribed during their participation in that study.~Participants not entering the trial from Study RP103-03 were started on twice a day administration of cysteamine bitartrate at a total daily RP103 dose of 70% of their pre-study total daily stable Cystagon® dose."

Trial Locations (10)

30322

Emory Children's Center, Atlanta

60614

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago

77030

Texas Children's Hospital/Baylor University, Houston

94115

California Pacific Medical Center (CPMC) Research Institute, San Francisco

94305

Stanford University Medical School, Stanford

Unknown

Hospices Civils de Lyon, Lyon

Hôpital Arnaud Villeneuve - CHU Montpellier, Montpellier

Hopital Necker, Paris

Robert Debre Hospital, Paris

Radboud University Nijmegen Medical Center, Nijmegen

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY