Actively Recruiting
A Clinical Study of NAD in the Treatment of Immune Thrombocytopenia
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-08-05
20
Participants Needed
1
Research Sites
58 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the safety and efficacy of nicotinamide adenine dinucleotide in the treatment of immune thrombocytopenia in patients who have not responded adequately or relapsed after first-line treatment and at least one second-line therapy including Anti-CD20 Antibody and/or TPO-RA.
CONDITIONS
Official Title
A Clinical Study of NAD in the Treatment of Immune Thrombocytopenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years and older, male or female
- Diagnosed with immune thrombocytopenia (ITP) for 3 months or more
- Have not responded to or have relapsed after corticosteroid therapy and at least one second-line treatment such as TPO receptor agonists
- Platelet count below 30 x 10⁹/L confirmed on at least two occasions within 2 days prior to study entry
- ECOG performance status score of 2 or less
- On stable dose maintenance therapy with only one concomitant medication (e.g., corticosteroids at ≤0.5 mg/kg prednisone or equivalent, or TPO receptor agonists) for at least 4 weeks before starting the study drug
- Female participants of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 4 months after treatment
- Male participants must agree to use effective contraception during the study and for 6 months after treatment
- Provided signed and dated informed consent
You will not qualify if you...
- Allergy to nicotinamide adenine dinucleotide or any excipients
- Prior CD38 monoclonal antibody treatment without efficacy
- Presence of autoimmune hemolytic anemia or other secondary/genetic thrombocytopenias such as leukemia, lymphoma, multiple myeloma, aplastic anemia, myelodysplastic syndrome, Evans syndrome, common variable immunodeficiency, systemic lupus erythematosus, cirrhosis, antiphospholipid antibody syndrome, pseudo-thrombocytopenia, or drug-induced thrombocytopenia
- History of thrombosis or embolism within 12 months before starting the study
- Severe bleeding events like hemoptysis, gastrointestinal bleeding, intracranial hemorrhage, sepsis, or other irregular bleeding
- Participation in another clinical trial involving investigational drugs or vaccines within 4 weeks or 5 half-lives before study drug
- Use of anticoagulant or antiplatelet drugs (e.g., aspirin) within 2 weeks before study drug
- Emergency treatment for ITP within 2 weeks prior to study drug
- Use of certain immunosuppressive drugs (azathioprine, danazol, cyclosporine A, tacrolimus, sirolimus) within 4 weeks, or CD20 monoclonal antibodies (rituximab, cyclophosphamide, vincristine) within 3 months prior to study drug
- Splenectomy within 6 months before study drug
- Receipt of live vaccine within 4 weeks before study drug or planned live vaccine during study
- History of allogeneic stem cell or organ transplantation
- Clinically significant diseases that may risk safety or affect assessments
- Malignancy within 5 years prior to screening except certain cured skin or cervical cancers
- Abnormal liver or kidney function tests at screening
- Positive tests for HIV, syphilis, hepatitis B or C infection
- Pregnancy, breastfeeding, or plans to become pregnant or breastfeed during study
- Mental disorders preventing consent or participation
- Unresolved toxicities from prior treatments
- Any other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chinese Academy of Medical Science and Blood Disease Hospital
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
Y
Yunfei Chen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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