research DAA's

[Mari5116]

How does one research the results of phase1 clinical trials on a new drug?  If anyone has any suggestions I'd appreciate hearing them.

thanks!

[Mari5116]

Janice,

I've just returned from vacation and read your post. Currently there are phase 2 trials running for PSI-7977 in varying combinations.  Since phase 2 trials are running I'd assume phase 1 are completed and the results must be somewhere.  Thus far I've not found them.  Sorry I'm not of more help, let me know what you turn up as well.
Best...  

[onewonders]

Hi,

When you find the info you are researching, would you please post it here?  I would love to see it.  Thanks.  Also, any info you can post regarding your clinical trial choices and experience would be greatly appreciated.

Just for clarification, are you saying that there is a finished Phase 1 clinical trial with PSI-7977  and Ritonavir and that the data for that trial has been published?  

I am interested in getting any and all information I can get on PSI-7977 alone or in combination with any other DAA or with SOC.

Janice

[Mari5116]

Thank you for your time.

It's the Phase 1 specifically I was looking for before decideing on which Phase 2.  There is a clinicaltrials.gov/achive that I need to tweak a bitmore, I think.

[onewonders]

http://clinicaltrials.gov/ct2/results?term=PSI-7977

If this link doesn't work, go to:  clinicaltrials.gov and type PSI-7977 in the search box.  It should take you to the list of currently posted trials.  Trials listing are updated regularly.

1 Active, not recruiting Dose-Ranging Study of PSI-7977 in Combination With SOC in Treatment Naïve GT 1 HCV Patients; Condition:Hepatitis C; Intervention: Drug: PSI-7977;

2 Recruiting PSI-7977 With Pegylated Interferon and Ribavirin Hepatitis C Virus (HCV) Genotypes 1,4,5,6; Condition:Hepatitis C, Chronic; Intervention: Drug: PSI-7977 with PEG/RBV;

3 Recruiting Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3; Condition: Chronic Hepatitis C Infection
Intervention: Drug: PSI-7977 with and without ribavirin (RBV) and/or Pegylated Interferon (PEG-IFN);

4 Active, not recruiting Safety Study to Investigate PSI-7977 in Combination With SOC in Treatment-Naïve HCV Patients With Chronic Hepatitis C Virus(HCV) Infection
Condition: Hepatitis C Virus; Interventions: Drug: PSI-7977 and SOC (PEG-IFN and RBV);   Drug: PSI-7977;

5 Recruiting Study to Determine the Safety and Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Who Have Previously Not Been Treated With Standard of Care; Condition: Chronic Hepatitis C; Interventions: Drug: PSI-7977;   Drug: BMS-790052;   Drug: Ribavirin

[onewonders]

Great source for HCV drug research information

http://hcvadvocate.org/hepatitis/hepC/HCVDrugs.html

[onewonders]

http://hcvadvocate.blogspot.com/2011/07/pharmasset-announces-final-svr-data.html

PRINCETON, N.J., July 20, 2011 /PRNewswire/ -- Pharmasset, Inc. (Nasdaq: VRUS) announced today the final sustained virologic response (SVR) results from its phase 2b PROTON study with PSI-7977 dosed once daily in combination with peginterferon alfa 2a and ribavirin (Peg-IFN/RBV) in subjects with hepatitis C virus (HCV) genotype 2 or 3 who have not been treated previously. Twenty four out of twenty four subjects (100%) who completed treatment achieved an SVR, defined as HCV RNA below the limit of detection (<15 IU/ml) 24 weeks after the completion of treatment. No subject exhibited breakthrough on treatment or relapse after treatment.

Twenty five treatment-naive subjects with HCV genotype 2 or 3 were enrolled in an open label arm of the PROTON trial, receiving PSI-7977 400mg QD with Peg-IFN/RBV for 12 weeks, with no Peg-IFN/RBV follow-up. At the European Association for the Study of the Liver (EASL) in April 2011, Dr J. Lalezari presented interim results from this arm showing that 24 out of 24 subjects achieved an SVR12, defined as HCV RNA below the limit of detection (<15 IU/ml) 12 weeks after the completion of treatment. The combination was generally safe and well tolerated with one subject discontinuing treatment after day 1 and was lost to follow up. Overall PSI-7977 with Peg-IFN/RBV demonstrated potent viral suppression in subjects with HCV genotype 2 or 3 over 12 weeks of treatment.

Pharmasset anticipates reporting the SVR12 results from the PROTON trial in genotype 1 HCV subjects in the second half of 2011.

About the PROTON Trial

The Phase 2b PROTON trial enrolled 121 subjects infected with HCV genotype 1 who have not been treated previously. The primary endpoint of the trial will be the assessment of safety and tolerability of PSI-7977 in combination with Peg-IFN/RBV over 12 weeks with response-guided therapy allowing discontinuation of Peg-IFN/RBV at week 24. The trial was conducted in the U.S. Subjects were randomized (2:2:1) into one of 3 arms:

PSI-7977 200mg QD in combination with Peg-IFN/RBV for 12 weeks, followed by 12 or 36 weeks of Peg-IFN/RBV;
PSI-7977 400mg QD in combination with Peg-IFN/RBV for 12 weeks, followed by 12 or 36 weeks of Peg-IFN/RBV;
A control arm of matching placebo with Peg-IFN/RBV for 48 weeks.

In addition, 25 treatment-naive subjects with HCV genotype 2 or 3 were enrolled in a fourth, open label arm, receiving PSI-7977 400mg QD with Peg-IFN/RBV for 12 weeks, with no Peg-IFN/RBV follow-up. Subjects were followed for an additional 24 weeks after discontinuation of all therapy to assess SVR.

[cheesenrice]

research is harder than it seems - always check the dates and the validity of the website not so much with clinical trials but with hep c info in general - theres alot of bs out there

[Mari5116]

Thanks, it's PSI-7977 in two different trials.  I asked if it was the trials with BMS and she said no.  One is with retinovir (sp?).  She said she didn't yet have the paperwork and I simply can't recall what I'd previously read.  I'm sure I have it written down somewhere in my scribbles.  I'll research Pharamasset and see what I can find.  The way she said it I thought maybe there was a well worn ave to the info.

[Mari5116]

Thanks, it's PSI-7977 in two different trials.  I asked if it was the trials with BMS and she said no.  One is with retinovir (sp?).  She said she didn't yet have the paperwork and I simply can't recall what I'd previously read.  I'm sure I have it written down somewhere in my scribbles.  I'll research Pharamasset and see what I can find.  The way she said it I thought maybe there was a well worn ave to the info.

[cheesenrice]

what are the drugs in the trials - who manufactures these drugs - go to google or yahoo or  search this site ---- if the drug is telaprevir type phase 1 trials for telaprevir in the search box - or the manufacturer is vertex so type in vertex then select product info --- or tell the lazy pa to provide you with the info you request - if you let us know what you want to know im sure we can help

[Mari5116]

I have an opportunity to particiapte in one of two Phase 2 trials about which I had questions and was told by the PA the answers were in the results of Phase 1 trails.  Where are they to be found?

[HectorSF]

When the trial is completed the data will be published after that. You can look on the company's web site or just Google it to find the published data.
Not sure why you are looking at Phase 1 trials. Most phase I drugs never make it to market.


Hector.

[CaughtOffGuard]

Have you looked on this site?            http://www.clinicaltrials.gov

I hope this helps
christina

[cheesenrice]

type phase1 trial results for telaprevir or boceprevir or whatever in your search

Phase I trials are the first stage of testing in human subjects. Normally, a small (20-100) group of healthy volunteers will be selected. This phase includes trials designed to assess the safety (pharmacovigilance), tolerability, pharmacokinetics, and pharmacodynamics of a drug. These trials are often conducted in an inpatient clinic, where the subject can be observed by full-time staff. The subject who receives the drug is usually observed until several half-lives of the drug have passed. Phase I trials also normally include dose-ranging, also called dose escalation, studies so that the appropriate dose for therapeutic use can be found. The tested range of doses will usually be a fraction of the dose that causes harm in animal testing. Phase I trials most often include healthy volunteers. However, there are some circumstances when real patients are used, such as patients who have terminal cancer or HIV and lack other treatment options. "The reason for conducting the trial is to discover the point at which a compound is too poisonous to administer."[21] Volunteers are paid an inconvenience fee for their time spent in the volunteer centre. Pay ranges from a small amount of money for a short period of residence, to a larger amount of up to approx $6000 depending on length of participation.

There are also different kinds of Phase I trial:


Read more: http://www.answers.com/topic/clinical-trial-1#ixzz1SbIeIESt