Most Frequently Asked Questions about the Trials

 

 

You have a question not listed here? Send us your questions and we will get back to you and may also add it to our list here.

Which trials are you offering for Hepatitis C?

 

We are working with the major companies that have Hepatitis C drugs in advanced trials. We have trials with Abbvie, BMS, Boehringer-Ingelheim, Gilead Sciences, Merck and Idenix Pharmaceuticals.

 

One new hepatitis c drug that has been recently approved is Sofosbuvir/SOVALDI.

 

The trials are very competitive, meaning that they fill quickly. Some of the hepatitis c trials involve only 3 months of therapy so they are over quickly and are replaced by new ones. Our research institute does not do trials for patients whose livers are already failing, sometimes called "decompensating".

 

We refer those patients to hepatologists who are better able to treat patients with failing livers. Our focus is to cure patients with hepatitis c long before their liver starts to fail. The new drugs can help us do that.

What are my chances of being cured in your hepatitis c trials?

 

We cannot guarantee that you will be cured but we can tell you that in some recent studies, we conducted here, we managed to cure 80-90% of patients. In other trials, it has been about ~ 50%-60%, but this is better than the older regimens with interferon and the trial regimens were much easier to take than interferon.

 

In general, we are doing trials that seek to improve over existing options and it is our hope that with these new hepatitis c drugs coming we will be able to cure everybody in a few years.

 

Whether your hepatitis c is cured with one drug or another combination can depend on your genotype, your liver and the types and combinations of drugs you receive.

 

The trials are being designed to create the best combination for everybody.

Are these drugs safe?

 

Drugs in hepatitis c trials have not yet been approved, meaning that their effectiveness and safety is still being closely studied. This is actually one of the purposes of the trial. The drugs we have in trials at Ruane Medical are mostly in Phase 3 meaning that they have already been taken safely by many patients in Phase 1 and 2 trials and are now allowed in Phase 3.

 

Phase 3 studies are the final studies that can lead up to FDA approval. For every trial, there is a document we will read through with you that details all the important information we have that you need to know about the drug and the trial.

 

We call this document "Informed Consent" and it tells you everything that will be asked of you in the trial; it is usually 25 pages long. Before you agree to be in the trial, you should take the document home to read at your leisure and discuss with your advisors and your doctor.

Am I getting a placebo or am I getting real medication?

 

In all our interferon free hepatitis c studies, patients receive active medications.

 

Do I need a liver biopsy if I want to participate in a trial?

 

No, you don't have to have a liver biopsy to be in a hepatitis c clinical trial. But you may need a special test of your liver called a Fibroscan. A Fibroscan is like an ultrasound. Instead of needles into the liver, we use the Fibroscan to send sound waves and the information back tell us the condition of your liver: whether it is soft and floppy like a normal healthy liver or less flexible like we see in conditions like cirrhosis.

 

The test is easy to perform and we do it right here in the office. It takes about 10 minutes to do and is painless. The Fibroscan is new to the US and because of this, we rarely need biopsies anymore. It gives us all the information we need.

 

Do I have to pay to be in a hepatitis c clinical trial?

 

No you do not pay anything to be in an interferon free clinical trial. In a clinical trial, the medications and procedures you need for the trial are provided at no charge.

 

When you are in a hepatitis c clinical trial, there are frequent office visits especially at the beginning of the trial. In the first three months of many trials, there can be as many as 9 visits.

 

Once you are on the trial, each visit takes about an hour. Most trials provide a stipend or payment to the patient to cover the cost of travel, such as gas, taxi or parking. The stipends vary from study to study but range from $50 to $90 per visit.

 

How soon can you get me into a trial?

 

We are a clinical research center with many trials so we can often get people in pretty quickly. But the hepatitis c trials are very popular, meaning we often have more patients who want to be in trials than there are spaces available. The best way to get a spot is to get in contact with us soon and be assessed.

 

What's the next step?

 

 

The first thing we will do is help you get copies of all your existing medical records. There are other particulars that affect how soon you can get into a trial. For example: the type of Hepatitis C you have ( "genotype"): some trials focus on Genotype 1 ,2 or 3. You may have other medical conditions that can affect whether you can be enrolled.

 

Other drugs you are taking may affect the trial drugs and cannot be allowed. Some people have both HIV and Hepatitis C. Fortunately, there are now trials available for patients who have both HIV and Hepatitis C. In general, the trials are getting more flexible because we no longer use Interferon.

 

Where are you located?

 

We are located in a major medical building across the street from Olympia Medical Center in Los Angeles. Our building is located on Olympic Blvd. between Fairfax and La Brea Blvds. There is valet parking right next to the building. We are also easily accessible by public transportation.

 

More information on our dedicated hepatitis c trials website, here.