iron deficiency anemia and classic paroxysmal nocturnal hemoglobinuria
Conditions
Interventions
intravenous iron sucrose:intravenous iron sucrose
iron dextran tablet:Oral iron dextran tablet
Sponsors
Institute of Hematology and Blood Diseases Hospital,Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Subject is diagnosed classic PNH and IDA within 60 days prior to participating this clinical study; 2. Male and female subjects aged between 18 and 65 years; 3. Expected lifetime >24 weeks. ECOG performance status of 0, 1, or 2. Subjects didnt use intravenous iron products within 30 days or oral iron products (>27 mg/d)within 7 days prior to the first day of dosing; 4. Subject is considered reliable and capable of adhering to the protocol, visit schedule or medication intake according to the judgement of the investigator; 5. Subject is informed and given ample time and opportunity to think about a possible participation and has given written informed consent; 6. Subject with no active infectious disorders; 7. Subject must meet the following clinical laboratory criteria: (1) AST and ALT=2.5×the upper limit of the normal range(ULN); (2) myocardial enzyme =2.5×ULN; (3) ejection fraction(ECHO)>45%; 8. Female subject is postmenopausal or agree to perform effective contraception; 9. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Subject with any mal-absorption syndrome (e.g. celiac disease, atrophic gastritis); 2. Subject with a history of thalassemia or sickle cell anemia; 3. Subject with other sideroblastic,sideroachrestic,hyposideremic or hypochromic anemia such as infection,lead or tumor anemia; 4. Subject with untreated concurrent Vitamin B12 or folate deficiency at baseline; 5. Subject with severe concomitant medical or surgical diseases,in particular hiatus hernia,esophagitis, acid peptic disorders and hemophilia; 6. Subject with active GI bleeding or acute bleeding within 4 weeks; 7. Subject with cancer regardless the relation to anemia,or those with any serious hepatic disorders/insufficiencies (AST or ALT at screening greater than 3 times the upper limit of normal), or other serious illness which investigator think it is unsuitable; 8. Subject with a history of any form of iron overload(hemochromatosis); 9. Subject with any medical or psychiatric condition that,in the opinion of the investigator, can jeopardize or would compromise the subjects ability to participate in this trial; 10. Subject has a history of contra-indications or hypersensitivities to iron preparations or components; 11. Subject has a history of transfusion with the last 1 month before study; 12. Use of hematinics including other iron products and the traditional Chinese medicine or Chinese formulated products currently or within 2 weeks prior to the first day of dosing; 13. Concomitant therapy with any of the following medications which are not allowed by the protocol: thyroxine, tetracyclines, quinolones, antacid salts, H2 –blockers, PPL, L-methyldopa, levodopa, cholestyramine, penicillamine, gold, thioctacid, a-tocopherol, NSAIDs, poylphenols, phytates, oxalates, tannic acids and Mg/Ca-salts; 14. Subject has a history of having chronic alcohol or drug abuse within the last 6 months; 15. Subject has participated in another trial of an investigation drug (or medical device) within the last 30 days or is currently participating in another trial of an investigation drug(or medical device); 16. Subject has previous participated in this clinical study or previous assignment to treatment in a trial of the current drug under investigation in the last 3 months prior to study onset; 17. The subject,in the opinion of the investigator, is not able to comply with the study protocol or is unsuitable for any other reasons; 18. The subject with a history of hereditary spherocytosis, autoimmune hemolytic anemia, glucose-6-phosphate dehydrogenase (G6PD) deficiency and paroxysmal cold hemoglobinuria(PCH).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| hemoglobin;quality of life;MCV;serum ferrintin;serum iron;transferrin saturation;serum concentration of soluble transferrin receptor;hepcidin;hepcidin; | — |
Countries
China
Contacts
Public ContactZhang Fengkui
Department of GCP, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed