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Study of Longitudinal Observation for Patient With X-linked Hypophosphatemic Rickets/Osteomalacia in Collaboration With Asian Partners

Study acronym: SUNFLOWER
StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Minor 3 versions Re-verified since Aug 4, 2023, no change to tracked fieldsv6-v8
  2. Notable Primary and study completion dates: Dec 31, 2023 to Dec 31, 2028v5 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 240 to confirmed 226
    • Eligibility criteria revised
    • Secondary endpoints: details revised at 3 of 3 entries
    • Site details revised
  3. Minor Re-verified, no change to tracked fieldsv4
  4. Notable Enrollment target: 160 to 240v3
  5. Minor Site contact updatedv2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Through observation of patients with X-linked hypophosphatemic rickets/osteomalacia (XLH) for up to 10 years, the study intends to collect data that allow achievement of the following objectives: 1. To determine medical characteristics of the disease and the disease process 2. To determine physical and psychological burden on patients as well as economic burden 3. To assess the efficacy and safety of the treatment of the disease
Trial Details
NCT Number NCT03745521
Lead Sponsor Kyowa Kirin Co., Ltd.
Conditions
(from sponsor)
X-Linked Hypophosphatemia
Related terms Familial Hypophosphatemic Rickets
Enrollment 226 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov