Clinical Trial of high-dose IVIG therapy during pregnancy for women with the historyof pregnancy ending in documented neonatal hemochromatosis
- Conditions
- Prevention and regression of recurrent NH and NH-related fetal demise
- Registration Number
- JPRN-jRCT1091220353
- Lead Sponsor
- CCHD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 8
(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
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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