SciClone's Final Clinical Trial For Zadaxin In Non-Cirrhotic Patients

[MKAndrew]

So, when will Zadaxin be approved?  Here's what's happening.  The FDA is extremely happy with SciClone's data, but the agency is requesting one final clinical study.  SciClone has already done a clinical trial for cirrhotic patients, so now the FDA wants to see a comparative study: Is there a difference between Zadaxin's effect on cirrhotic and non-cirrhotic patients?

Recruitment is the issue here.  SciClone is looking for genotype 1 patients without cirrhosis who are willing to do treatment in a clinical trial.  It's a bit more difficult to make contact with this population, and patients without cirrhosis are less likely to do a clinical trial involving a placebo.

So what are the advantages of doing this trial if you don't have cirrhosis, and there is a possibility of getting sugar water instead of Zadaxin?  Well, you get 48 weeks of free treatment on Pegasys + ribavirin, plus free healthcare, reimbursments and a 6-month follow up.  So for non-cirrhotic patients who want to do normal treatment but have no insurance, this is a great opportunity.

This final trial is giving us important information about Zadaxin's likely date of full FDA approval for hepC.  You can keep watch by going to SciClone's website.  When they stop recruiting for this trial, you can figure a year, plus 6 months for SVR follow-up, then a few months more for the FDA to finalize.

If you want to participate in this study, go to the following URL:

http://www.sciclone.com

You can also write to me for Zadaxin info at ***@****

[GreatBird]

I was curious so I went to the site. I don't qualify since I'm a treatment naive patient. Here are the requirements:


Trial Entry Requirements

SciClone Pharmaceuticals’ U.S. phase 3 clinical trials testing thymalfasin (thymosin alpha 1, ZADAXIN) for the treatment of hepatitis C are now open for accrual of patients. The requirements to enter the trial include the following:

    * Patient must be at least 18 years of age and live close to a city with an established site currently enrolling patients


    * Patient has been diagnosed with hepatitis C


    * Patient has been treated previously for at least 12 weeks with either interferon or interferon plus ribavirin


    * At the end of previous treatment with either interferon or interferon plus ribavirin, patient must have tested positive for hepatitis C virus RNA

[kojak66]

You must not of been treated for at least 6 months prior to going into this trial.  I've checked into this trial and won't be eligable until April.  I've previously gone  through the trial involving one full year of double doses of PegIntron, and it would be rather stupid of me to go through the hell of 1 yr of ANY kind of interfuron just to find that I received a placebo.
You would think that they would put anyone who has gone through the trial involving double doses of PegIntron and has not responded into a seperate group. Six out of seven nonresponders that went into the double dose of Peg trial at my drs. office, became nondetectable after 3 months.  I was the seventh guy.
Common sence would tell you that people like me are the ones that they should be REALLY be concerned with.  If Zadaxin works for me, it could very well be a REAL winner.