Safety and efficacy of a 10% intravenous immunoglobulin preparation in patients with immune thrombocytopenic purpura: results of two international, multicenter studies.
To assess safety and efficacy of a 10% intravenous immunoglobulin in patients with primary immune thrombocytopenic purpura (ITP).



ITP patients in two multicenter studies (Trials A/B) were treated with 2 g/kg Flebogamma®10% DIF (over 2-5 days) and were followed up to 1-3 months.



18 patients in Trial A and 58 in Trial B were enrolled (12 children in Trial B). The response rate (platelet count ≥50 × 109/l) was 72.2% (Trial A) and 76.1/100% (adults/children; Trial B). Most patients improved bleedings (83.3% Trial A; 88.9% Trial B). Potential treatment-related adverse events were reported by 38.9% (Trial A) and 30.4/83.3% (adults/children; Trial B) of patients. All serious adverse events (five patients) resolved without sequelae.



Flebogamma 10% DIF was effective and safe in patients with primary ITP.
Hematology Research Centre of Russian Academy of Medical Science, Moscow, Russia.
Lidia
L
Kovaleva
Sahyadri Speciality Hospital, Pune, Maharashtra, India.
Shashikant
S
Apte
Narayana Hrudayalaya Hospitals, Bangalore, Karnataka, India.
Sharat
S
Damodar
Ruby Hall Clinic, Pune, Maharashtra, India.
Vijay
V
Ramanan
Federal Research Clinical Centre of Pediatric Hematology, Oncology & Immunology, Moscow, Russia.
Svetlana
S
Loriya
Clinical Trials Department, Instituto Grifols S.A., Barcelona, Spain.
Jordi
J
Navarro-Puerto
Columbia Comprehensive Cancer Care Clinic & Research Institute, 1705 Christy Dr. Suite 214, Jefferson City, MO 65101, USA.
Ali
A
Khojasteh
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007167:Immunotherapy / Q000379:methods*; D007391:International Cooperation; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016553:Purpura, Thrombocytopenic, Idiopathic / Q000276:immunology / Q000401:mortality / Q000628:therapy*; D016019:Survival Analysis; D016896:Treatment Outcome; D055815:Young Adult
D016756:Immunoglobulins, Intravenous; D007166:Immunosuppressive Agents
Flebogamma® 10% DIF; hemorrhage; immune thrombocytopenic purpura; intravenous immunoglobulin