Extension Study

[partimefriend]

I was under the impression that the 2001 and Monarch trials were the only open label studies. This extension shows open label in a few areas. For example:

Chronic HBV patients will receive 9 doses of open-label ARC-520 once every 4 weeks and be evaluated for safety and efficacy.

Masking: Open Label
   Do I understand open label correctly? I was under the impression that open label means that Arrowhead Research would have real time information about the trial, and could release it at any time.
I think we have a new open label extension study for Heparc-2002 and 2003

ClinicalTrials.gov Identifie
NCT02738008


clinicaltrials.gov/ct2/show/NCT02738008?term=arrowhead+pharmaceuticals&rank=5

[coldlander]

You understand open label correctly.  Looks like this is a new extension.

[dig]

partimefriend:


Good catch on the 2007 Extension.


Originally Arrowhead said that they would have 2 studies (2006 and 2007) that would be extension studies of 2002 and 2003. With the IDNA produces a significant amount of HBsAg discovery, they decided to take only those patients that reached .5 log KD with the 4 doses given in 2002-3 studies. When they made this change it virtually garneted that the 2007 extension study would be open label.


www.medicinenet.com/script/main/art.asp?articlekey=11177


Double-blinded study: A medical study in which both the subjects participating and the researchers are uaware of when the experimental medication or procedure has been given. Double-blinded studies are often used when initial studies shows particular promise.

2002 and 2003 were double blinded so, only accepting patients that got .5 log KD would break the blind. With no way to keep the placebo patients from the 2002-3 studies, the extension has to be done with no placebo patients or open label.


Interesting to see they are planning on 50 participants moving on to this study.