Aug 4, 2010
I participated in the phase III trial of Tesamorelin and the extension in LA, CA. I rec'd the drug during the trial and the placebo in the extension. I was notified about a year after the trial that I had developed antibodies to the drug. I was told there was no health threat and eventually they would go away. My question is whether or not I would be a candidate for the drug once it is available due to having, during the trial, developed the antibodies?
If the drug would no longer be effective due to antibodies, and this would be the case for others who would take the drug, wouldn't it be a serious consideration for the manufacturer to develop some sort of test to determine whether the patient would develop antibodies, rather than have the patient pay for the drug and thereafter find out that he/she has developed antibodies?
I can't seem to get an answer for either question from the manufacturer or the study center.
Response from Dr. Henry
Very good questions for which I don't have any solid answers. If any reader knows of a reference that would be helpful please post. KH
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