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Study to Evaluate the Safety, PK, PD, and Efficacy of PRX-102 in Japanese Patients With Fabry Disease

Study acronym: RISE
StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 9 to 10 Study description expanded, about 7 wordsv11 Show 1 more changeShow less
    • Study description expanded, about 7 words

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  2. Primary completion date: Mar 2026 to Oct 2027 Enrollment target: 18 to 16 · Completion date: Mar 2028 to Aug 2029 · Eligibility criteria expanded, about 241 words · 1 morev10 Show 4 more changesShow less
    • Enrollment target: 18 to 16
    • Completion date: Mar 2028 to Aug 2029
    • Eligibility criteria expanded, about 241 words
    • Site details revised at 1 of 9 sites

    See this version in full on ClinicalTrials.gov ↗

  3. Site details revised at 9 of 9 sitesv9
  4. Site details revised at 9 of 9 sitesv8
  5. Study sites: 8 to 9 Eligibility criteria expanded, about 27 wordsv7 Show 1 more changeShow less
    • Eligibility criteria expanded, about 27 words

    See this version in full on ClinicalTrials.gov ↗

Show 5 earlier versionsHide 5 earlier versions
  1. Site details revised at 5 of 8 sitesv6
  2. Site details revised at 3 of 8 sitesv5
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Aug 2023 to Aug 1, 2023 · Site details revised at 8 of 8 sitesv4 Show 2 more changesShow less
    • Start date changed from estimate of Aug 2023 to Aug 1, 2023
    • Site details revised at 8 of 8 sites
  4. Start date: May 2023 to Aug 2023 Study sites: 1 to 8 · Collaborators expanded, about 2 wordsv3 Show 2 more changesShow less
    • Study sites: 1 to 8
    • Collaborators expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  5. Start date: Mar 2023 to May 2023 Study sites: 0 to 1v2 Show 1 more changeShow less
    • Study sites: 0 to 1
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The aim of this study is to evaluate the safety and efficacy of pegunigalsidase alfa in Japanese patients (adults and adolescents) affected by Fabry disease. It is planned of a total of approximately 16 male and female Fabry disease patients between the ages of 13 and 70 years to be part of the study. The study is conducted in Japan.
Trial Details
NCT Number NCT05710692
Lead Sponsor Chiesi Farmaceutici S.p.A.
Collaborators: ICON plc
Conditions Fabry Disease
Enrollment 16 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov