What was the estimated time to complete the IDE trials?
Does anyone have an idea as to how long it takes to get results on the IDE trails. What specific added information do we expect to see at the end of the trials? Is there going to be any analysis as to how the IDE extends one's life and quality of life, since these tests are going to be performed on patients near end of life?
There has been no estimate given for either the beginning or end of the phase one trial. The end point of any phase one trial is demonstration of product safety, but I don't believe there is a rule against releasing any positive data collected along the way. I would imagine that we will get day 7 and 30 viral loads, once all the patients have reached that point. The data should be similar to what was collected in India, although the protocol does call for longer HP treatment times than in the past, which should speed up viral load reduction (fingers crossed). There is also the added benefit of it coming out of a well know and respected American research institution.
I think that it will take a few months to set things up at the clinical trial site and recruit all the patients. I'd be happy with positive data and discussions of a follow up study by some time in the fall or early winter.
Without looking it all up again, this is what I think I know. The initial trial is a safety test which will last three weeks and I think the results will be almost immediately apparent. There are certain things that go wrong with dialysis filters (search for a new FDA guide on blood purifying devices from around June 15th or maybe 19th. It gives a lot of info on safety concerns). I think there must be analysis on what the purifier picks up, because anyone in research can't pass up an opportunity for data collection.
This is what I am concerned about. I remember reading the conditions for suitability for the tests in India and there were a lot of factors that would exclude people from the treatment. I am wondering if End Stage Renal Disease patients will also have health aspects that disqualify them from the study or make it hard to determine just what benefit the Hemopure gizmo is providing. As this is primarily a safety trial it is a moot point, and we may have to wait for the next stage of testing, which will be efficacy. I am hoping that the efficacy testing will swiftly follow the safety test, but I'm an optimist. There may be modifications, and perhaps a further safety trial.