A Multicenter Prospective Study of Iptacopan in the Treatment of Refractory/Relapsed Autoimmune Hemolytic Anemia (AIHA)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBing Han
About this trial
To evaluate the efficacy and safety of ipecopam in the treatment of refractory/relapsed AIHA.
Eligibility criteria
Qualifiers
Voluntarily signed an informed consent form (ICF);
Males or females aged 18 or older;
Physical status score [Eastern Cooperative Oncology Group (ECOG) score] ≤2;
Confirmed diagnosis of primary AIHA or secondary autoimmune disease (except rheumatoid arthritis and systemic lupus erythematosus) with underlying disease in a stable state;
Disqualifiers
Presence of secondary AIHA outside the inclusion criteria;
Hb <100 g/L due to non-AIHA factors; and
Infections requiring systemic therapy;
Those with a past history of malignancy (except cured basal cell carcinoma of the skin or cervical carcinoma in situ);
Trial design
Treatments tested in this trial
- Iptacopan
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Bing Han
Lead sponsor
Peking Union Medical College Hospital
Sponsor institution
Source ClinicalTrials.gov