Pilot Study of Safety, Tolerability, Pharmacokinetics/Pharmacodynamics of RP103 Compared to Cystagon® in Patients With Cystinosis
A Pilot Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Cysteamine Bitartrate Delayed-release Capsules (RP103), Compared to Cysteamine Bitartrate (Cystagon®) in Patients With Nephropathic Cystinosis
Sponsor: Amgen
Listed as NCT00872729, this PHASE1/PHASE2 trial focuses on Cystinosis and remains completed. Sponsored by Amgen, it has been updated 10 times since 2009, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Change History
10 versions recorded-
Jan 2025 — Present [monthly]
Completed PHASE1/PHASE2
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Sep 2024 — Jan 2025 [monthly]
Completed PHASE1/PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE1/PHASE2
Phase: PHASE1_PHASE2 → PHASE1/PHASE2
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Jan 2023 — Jul 2024 [monthly]
Completed PHASE1_PHASE2
-
Dec 2022 — Jan 2023 [monthly]
Completed PHASE1_PHASE2
▶ Show 5 earlier versions
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Jan 2021 — Dec 2022 [monthly]
Completed PHASE1_PHASE2
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE1_PHASE2
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Jul 2017 — Jun 2018 [monthly]
Completed PHASE1_PHASE2
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Feb 2017 — Jul 2017 [monthly]
Completed PHASE1_PHASE2
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Jan 2017 — Feb 2017 [monthly]
Completed PHASE1_PHASE2
First recorded
May 2009
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Amgen
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
- • San Diego, United States