Active — Not RecruitingNot Applicable

Real-life Treatment Outcomes of Ravulizumab in PNH

Poland64 participantsStarted 2025-02-06

Plain-language summary

The PNH-RECORD study, a Polish multicenter observational (non-interventional), open-label, retrospective with prospective follow-up.

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Adult (aged ≥18) patients with PNH receiving ravulizumab treatment in the frames of NDP in Poland.
✓. Patients willing to participate in the study and signed ICF.

✕. Those who participated in ravulizumab clinical trial in the past, and/or those who participated/plans to participate in clinical trial on/after the date of first ravulizumab infusion through NDP.
✕. Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Change in LDH levels from index date (first dose of ravulizumab) at every 6 month

Timeframe: up to 36 months

Proportion of patients achieving or remaining at LDH<1.5 ULN at every 6 month

Timeframe: up to 36 months

NCT IDNCT06633536

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2028-08-01