Study to Assess the Safety, Tolerability, Efficacy and PK of APL-2 in Patients With Warm Type Aut… (NCT03226678) | Clinical Trial Compass
CompletedPhase 2
Study to Assess the Safety, Tolerability, Efficacy and PK of APL-2 in Patients With Warm Type Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD)
United States24 participantsStarted 2017-08-31
Plain-language summary
This study is to assess the safety, tolerability, preliminary efficacy, and pharmacokinetics of APL-2 in subjects with warm Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. At least 18 years of age.
✓. Weight \< 125 Kg.
✓. Subjects must have a primary diagnosis of wAIHA or CAD defined by the presence of hemolytic anemia and positive DAT for wAIHA (IgG) or CAD (C3).
✓. Hemoglobin \<11 g/dL.
✓. Signs of hemolysis with abnormal values by any of the hemolytic markers:
✕. Prior treatment with rituximab within 90 days.
✕. Deficiency of iron, folic acid and vitamin B12 prior to treatment phase
✕. Abnormal liver function as indicated by a direct bilirubin above normal level, and/or an AST or ALT level \> 2x upper limit of normal. Please note elevated indirect bilirubin due to hemolysis is not an exclusion criteria.
✕. Elevated bilirubin not due to active hemolysis. Any elevation of bilirubin \>ULN will require Sponsor review and approval for subject enrollment into the trial.
✕. Active aggressive lymphoma requiring therapy or an active non-lymphatic malignant disease other than basal cell carcinoma or carcinoma in situ (CIS) of the cervix.
What they're measuring
1
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) Including by Severity
Timeframe: Part A:From first dose of study drug (Part A Day 1) up to 30days after last dose of study drug in Part A,approximately 366days Part B:From first dose of study drug (Part B Day 1) up to 56days after last dose of study drug in Part B,approximately 980days
✕. Presence or suspicion of active bacterial or viral infection, in the opinion of the Investigator, at screening or severe recurrent bacterial infections.
✕. Participation in any other investigational drug trial or exposure to other investigational agent, device, or procedure within 30 days prior to screening period.
✕. Pregnant, breast-feeding, or intending to conceive during the course of the study, including the Post-Treatment Phase.