danoprevir/RO5024048, exclusion criteria?

[Cheesegrater]

Would anyone know if this study

A Study of Danoprevir/Ritonavir and Copegus With RO5024048 and/or Pegasys in Patients With Chronic Hepatitis C
ClinicalTrials.gov Identifier: NCT01331850

accepts those who have previously taken an HCV protease inhibitor?

The inclusion/exclusion criteria does not mention this, only that previous treatment failures are ok as long as treatment ended more than 12 weeks before. I assume this means SOC.

???

Cheese

[Cheesegrater]

Yes, I have contacted them.

No reply yet.

[spectda]

Why not contact them?

Contact: Please reference Study ID Number: WV21913 888-662-6728 (U.S. Only) ***@****

Good luck-
Dave

[Cheesegrater]

Come to think of it, many who tried the protease inhibitor DID fail standard treatment well before they tried the protease inhibitor.  Some several times before they tried the protease inhibitor.  Unless the exclusion criteria states it, you would think these patients would qualify as they did fail standard treatment.
You'd also think they would put the wording in the exclusion criteria:
"Anyone who has taken a protease or polymerase inhibitor"
but they have not.  Other trials I have looked into specify this point in the exclusion criteria. If it will exclude a patient, it should be listed, otherwise I'll keep trying.

Cheese

[22hamilton]

Glad things are ok-ish evangelin, I understand the predicament. Is your husband taking PPC as well ? Im still trying to find a cheaper supplier than the phoscol brand.

Stay well

[evangelin]

A trial coordinator told me that the Alinia that my husband took last time could even be a disqualification for some trials.
In 7 years of fighting this, HR's supplements are the only good thing  that ever happened for us. If every avenue is blocked for getting rid of the virus, your only hope is living better with the virus.  The supplements have returned  a quality of life .  We would love to land the plane but we can't.  We are still circling the airport but at least Joe is now not miserable while waiting.
Best Wishes,
Ev

[22hamilton]

This is an intersting question and something I'm contemplating myself. This trial looks very promising but wont reach phase 3 until end of 2012 Im told. I need to treat now with a PI but if I fail it will close the door on this Roche trial I think. What a dilemma.

This is new territory for everyone but we can only do our best with whats available. Good luck with finding a suitable treatment. !

[Cheesegrater]

I think you are right.
previous STANDARD therapy.
Shame,...those took a chance on the protease inhibitors and broke-through are now unable to get into more promising trials.

[can-do-man]

Official Title: A Randomized Open-label Study to Evaluate the Sustained Virologic Response of Danoprevir/Ritonavir and Copegus in Combination With RO5024048 and/or Pegasys in Chronic Hepatitis C Genotype 1 Patients Who Failed Previous Standard Therapy

The key words here are "Previous Standard Therapy"..........So this trial would not allow someone who had been in another trial with one of the PI's.

Best to you
cando