A Multicenter Prospective Study of Iptacopan in the Treatment of Refractory/Relapsed Autoimmune Hemolytic Anemia (AIHA)

ConditionsAIHA - Warm Autoimmune Hemolytic Anemia AIHA - Cold Autoimmune Hemolytic Anemia

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

Iptacopan
Drug
Iptacopan

Treatment groups

20 Participants

are divided into 1 treatment group

Group A: Iptacopan-AIHAExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Overall response rate

Time frame

3 months

complete response rate

Time frame

6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bing Han

Lead sponsor

Peking Union Medical College Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: