RecruitingPhase 3

Efficacy and Safety of Switching From Anti-C5 Antibody Treatment to Iptacopan Treatment in Study Participants With Atypical Hemolytic Uremic Syndrome (aHUS)

China, France50 participantsStarted 2024-02-28

Plain-language summary

The purpose of this Phase 3 study is to evaluate the efficacy and safety of iptacopan upon switching from anti-C5 antibody to iptacopan treatment in study participants with aHUS.

Who can participate

Age range18 Years – 100 Years

SexALL

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Inclusion criteria

✓. Hematological normalization in platelet count ≥150 x 10\^9/L and LDH below upper limit of normal \[ULN\], and
✓. Stable kidney function as defined by serum creatinine values within ±15% during the Screening period

What they're measuring

Percentage of participants free of TMA manifestation

Timeframe: 12 months

Trial details

NCT IDNCT05935215

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-07-21

Contact for this trial

Novartis Pharmaceuticals

1-888-669-6682 novartis.email@novartis.com

View on ClinicalTrials.gov More Atypical Hemolytic Uremic Syndrome trials