Showing posts with label Frantisek. Show all posts
Showing posts with label Frantisek. Show all posts

Friday, December 5, 2008

New to Me: Phase-I Clinical Trial of Polyclonal Anti-T-Cell (ATG)

This clinical trial treats honeymoon diabetes (during first 6 weeks) with ATG. The hope is for some beta cell preservation. This is a prelude to Gitelman's phase-II ATG trial, described here: http://joshualevy.pbwiki.com/DiabetesCureReadyForHumanTrials#NIAID/ITNGitelmanThymoglobulin/ATG, except that this trial is still ongoing. However, they have published interrum results (on their first 17 patients) here: http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1783538

My eyeballing of the interrum results looks like the ATG group used about 60% as much insulin as the untreated group after about 12 months, and this seemed pretty stable. It did not look to me like the effect was "wearing off". This was good enough to motivate a follow-on, phase-II clinical trial, which is currently underway. I'm also very interested in what happens to these 17 patients after 2 years, 3 years etc. If the lower insulin requirement gradually goes away, that's too bad. If it stays stable, then that is very promising. If it gets even better slowly over time, that suggests that the body is growing new beta cells, and would be good news both for ATG treatments and for many others.

US Government Clinical Trial Record: http://clinicaltrials.gov/ct2/show/NCT00190502

Estimated Enrollment: 28
Study Start Date: November 2000
Estimated Study Completion Date: December 2007

This work was sponsored by the Ministry of Health, Czech Republic, and is being done in Prague.