Trials

[djbn13]

To qualify for a trial do they take people with underlining conditions like lung diseases or do they only want other wise healthy people.

[uncledudeness]

I am going thru the pre-screening for the BMS-790052 NS5A trial. my  platelet count is at 96K (at last blood test), and the cut-off for the trial is 100K. i am hoping that my platelet count has increased. If it hasn't I won't be included in the trial. So to answer your question, there are very strict guidelines relative to clinical trials. As Bill said, go to the website and read some of the trials.

[Bill1954]

Dj, every trial has it’s own parameters. If you go to clinicaltrials.gov, for instance, and locate a trial, they should list inclusions and exclusions under the term ‘eligablility’.

Here’s an example for a HCV trial that I picked at random:


http://clinicaltrials.gov/ct2/show/NCT00919633?term=hcv&rank=4

“Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

    * Signed patient consent form
    * Genotype 1 chronic HCV with detectable HCV RNA
    * No previous treatment for HCV infection
    * Hepatitis B and human immunodeficiency virus negative at screening visit 8.
    * Able and willing to follow contraception requirements
    * Screening laboratory values, test, and physical exam within acceptable ranges
    * Weight between 40 kg and 125 kg
    * Proficiency in the use of the external pump infusion system

Exclusion Criteria:

    * Current or planned enrollment in another investigational device or drug study
    * Anticipated inability to complete all clinic visits and comply with study procedures
    * History of, or any current medical condition, which could impact the safety of the subject during the study
    * Autoimmune hepatitis, suspected hepatocellular carcinoma, decompensated liver disease, or other known liver disease other than HCV
    * Alcoholism or substance abuse with <6 documented months of sobriety
    * Known allergy or sensitivity to interferons or ribavirin
    * Any other condition that, in the opinion of the Investigator, would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the study”

--Bill