Vertex Phase 3 Recruiting NOW

Today's Washington Post [back of the Health section] carried this announcement:

The Innova Fairfax Hospital Center for Liver Diseases is enrolling patients into clinical trials to evaluate novel drugs for the treatment of hepatitis C. Call for information or to find out if you are a candidate. 703 208 6637

This is the clinic where I and 9 other campers participated in the Prove 1 trial, and I have a durable SVR after 24 fun weeks of treatment. I'm sure other clinics around the country are also recruiting now. If you have read about the previous VX950/telapravir trials and are interested in participating in the Phase 3 trial, now would be a good time to contact a clinic involved in the trial and get in for a screening visit.

[Willy50]

I believe that these are considered Phase 2 trials

Please notice that one of these is a "rollover' trial for people who did not respond in past Vertex trials.  I believe generally speaking this may be for most people who were on either a SOC "control" arm or a "no ribiviren" arm in which only interferon and telaprevir was administered.  This I believe is for BOTH Europe and N. America.

The studies with the "Ti "in them are partnered with Tibotec and should be European studies. (that would be the final 3 trials here)

There is a second group of studies which I believe are European only which involve tests of genotypes 2, 3 & 4.

There is also a trial for BID dosing versis TID dosing (twice daily telaprevir dosing and 3 times a day dosing.  IF you are in Europe these might bear looking into.

best,
Willy



http://clinicaltrials.gov/ct2/show/NCT00535847?term=telaprevir&rank=8&show_locs=Y#locn
vertex Rollover trial
A Rollover Study for Subjects Participating in the Control Arm of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Whose Plasma HCV RNA Levels Did Not Respond to Therapy

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http://clinicaltrials.gov/ct2/show/NCT00561015?term=telaprevir&rank=4

VX-950-TiDP24-C209: A Phase 2a Partially Blinded Clinical Study to Evaluate the Viral Kinetics and Safety of Telaprevir in Patients With Genotype 2 or 3 Infection.

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http://clinicaltrials.gov/ct2/show/NCT00580801?term=telaprevir&rank=2

VX-950-TiDP24-C210: A Study to Assess the Activity of Telaprevir on Hepatitis C Virus in Treatment naïve Patients Who Are Chronically Infected With Hepatitis C Genotype 4 Infection

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http://clinicaltrials.gov/ct2/show/NCT00528528?term=telaprevir&rank=1

VX-950-TiDP24-C208: An Open-Label Study of Telaprevir Administered Every 12 or Every 8 Hours in Combination With Standard Treatment in Treatment naïve Patients With Chronic Genotype 1 Hepatitis C

[APKhaos]

Sorry, not so. I spoke to the clinic today, and they are recruiting for Phase 3. There are other trials ongoing, and recruiting, but P3 is on the move.

[Willy50]

That's great; I'm not sorry at all.  I'm delighted.  These were the only things listed (that I saw tonight) at clinical trials (and all Phase 2).  We will probably see the Phase 3 trials listed there very soon.

Vertex says they will have some sort of announcement soon before the annual stock meeting.

Thanks for the heads up.  I wanted to post the links anyway.  I'm excited to see what the Phase 3 trials will look like and where they will be offered.

Thanks again,
Willy