Prevention and regression of recurrent NH and NH-related fetal demise
Conditions
Interventions
Intervention type:DRUG
Name of intervention:high-dose IVIG therapy
Dose form / Japanese Medical Device Nomenclature:INJECTION
Route of administration / Site of application:INTRAVENOUS DRIP
Dose per ad
Sponsors
NCCHD
Jichi Medical University Hospital,Kanazawa University Hospital, Kagoshima City Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1)Pregnant woman who have had an infant diagnosed with NH by meeting either one of the following criteria a)An infant diagnosed with NH according to the Japanese Society of Gastroenterology, Hepatology and Nutrition (JPGHN) criteria b)Diagnosed as NH according to our pathology algorism criteria (2) Between 16 and 45 years of age at the time of the agreement acquisition (3) Pregnant woman who can visit a hospital in a prescribed schedule during the whole study (4) Written informed consent
Exclusion criteria
Exclusion criteria: (1)History of drug allergies for this study drug (2)History of IgA deficiency or patients with serum IgA less than 5 mg/dL at a screening test (3)History of thrombosis (4)History of myocardial infarction or brain infarction (5)Pregnant woman with abnormal ST wave on a screening ECG and who is suspicious about ischemic cardiac disease (6)Pregnant woman with cardiac failure or loss of cardiac function (7)History of hereditary fructose intolerance (8)History of hemolytic anemia or blood loss anemia (9)Pregnant woman with immune deficiency disease or at an immune suppressive status (10)Pregnant woman with abnormal AST,ALT,GTP defined as 1.5 times more than upper limit of each medical facility range at a screening test (11)Pregnant woman with creatinine > 1.0 mg/dl at a screening test (12)Pregnant woman with severe active autoimmune diseases including autoimmune hepatitis who is supposed to be inappropriate for pregnant status (13)Pregnant woman who has been already participant in other clinical study (14)Pregnant woman who is judged inappropriate for this trial by the physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of alive babies who have not had any of these treatments; postnatal IVIG, exchange transfusion, hemodialysis filtration, plasma apheresis and liver transplantation at 3 months after birth | — |
Secondary
| Measure | Time frame |
|---|---|
| The rate that women who have had an infant affected with NH get a liveborn baby, the survival rate of newborns at 3 months after birth, the rate of having liver transplantation newborns at 3 months after birth | — |
Countries
Japan
Contacts
Public ContactAiko Sasaki
NCCHD
Outcome results
None listed