Dear fellow members,
I recently sent a letter to the SMFM membership regarding the opening of the Momenta clinical trial for severe HDFN (
https://clinicaltrials.gov/ct2/show/NCT03842189?cond=HDFN&rank=2) .
M281 is a unique monoclonal antibody that blocks the FcRn receptor. This results in a placental blockade of IgG. Through a secondary mechanism, it will also lower the circulating pool of maternal IgG.
We are looking for patients prior to 13 weeks gestation with a history of severe HDFN at < 24 weeks gestation in a previous pregnancy (IUT with severe anemia, hydrops with elevated MCA, or fetal demise with confirmatory pathology) secondary to anti-D or anti-Kell.
Currently we are the only open center here in Houston for the trial although we anticipate 3 - 4 additional US sites opening in the coming months.
After confirmation of an antigen positive fetus by free fetal DNA, patients will receive weekly infusions of M281 from 14 - 35 weeks gestation at our center. Travel back home between infusions is allowed and expenses are covered. They must then deliver at our institution and then stay an additional 2 weeks. All travel and lodging expenses are covered by the trial.
Let me know if anyone is interested. My cell is 713-444-7603.
Thanks
Ken Moise
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Kenneth Moise, Jr.
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