Thank you for your interest in STEALTH C-3.

> What is the STEALTH C Clinical Trials Program?
> What is STEALTH C-3?
> What is the clinical trial investigating?
> What is the purpose of clinical trials?
> Who might be eligible for this study?
> Where are the STEALTH C-3 Study centers located?
> What are the risks in taking part in a clinical study?
> What is placebo?
> What if I get the placebo and not the investigational drug?
> What if I have questions?

What is the STEALTH C Clinical Trials Program?

STEALTH C is a series of clinical trials aimed at gaining a broad understanding of how an investigational drug (nitazoxanide) may benefit people with chronic hepatitis C genotype 1 when used in combination with peginterferon and ribavirin.

Speaking to a STEALTH C-3 physician / Study Coordinator is the best resource for more information.

If you do not wish to talk to one of the physicians running STEALTH C-3 and have questions, please e-mail Romark Laboratories at info@romark.com or call the Romark Information Center at (877) 925-4642, between the hours of 8.30 AM and 5.30 PM EST, for information. Calling a STEALTH C-3 trial center or Romark Laboratories does not place you under any obligation to participate in the STEALTH C-3 clinical trial.

What is STEALTH C-3?

STEALTH C-3 is a clinical trial whose goal is to gain a broad understanding about the safety and efficacy of an investigational drug (nitazoxanide) in people with chronic hepatitis C genotype 1 when used in combination with peginterferon and ribavirin.

What is the clinical trial investigating?

The aim of STEALTH C-3 is to find out if the investigational drug provides an improvement in sustained virologic response (SVR), or undetectable level of virus, with a treatment regimen of 4 weeks of investigational drug monotherapy followed by 48 weeks of standard of care plus investigational drug versus 4 weeks of pre-treatment with placebo followed by 48 weeks of standard of care and placebo.

Speaking to a STEALTH C-3 physician / Study Coordinator is the best resource for more information.

If you do not wish to talk to one of the physicians running STEALTH C-3 and have questions, please e-mail Romark Laboratories at info@romark.com or call the Romark Information Center at (877) 925-4642 between the hours of 8.30 AM and 5.30 PM EST for information. Contacting a STEALTH C-3 trial center or Romark Laboratories does not place you under any obligation to participate in the STEALTH C-3 clinical trial.

What is the purpose of clinical trials?

Clinical trials are carefully designed research studies that are used to answer specific questions about a new type of medical treatment or to study new ways of using a therapy. Clinical trials are developed in close coordination with regulatory authorities at the United States Food and Drug Administration (FDA) and are a crucial step in the development and approval of new medications.

Learn more about the purpose of clinical trials

Speaking to a STEALTH C-3 physician / Study Coordinator is the best resource for more information.

You may also call the Romark Information Center at (877) 925-4642 between the hours of 8.30 AM and 5.30 PM EST for information. Calling a STEALTH C-3 trial center or Romark Laboratories does not place you under any obligation to participate in the STEALTH C-3 clinical trial.

Who might be eligible for this study?

STEALTH C-3 is recruiting people who have been diagnosed with chronic Hepatitis C genotype 1 of at least six months duration, with laboratory and liver biopsy findings showing chronic liver disease consistent with chronic hepatitis C, and who have had no prior treatment for chronic hepatitis C. These individuals may be eligible for treatment with a new investigational drug in combination with the current standard of care therapy for chronic hepatitis C. Other restrictions apply.

Learn more about eligibility requirements for the STEALTH C-3 trial

Speaking to a STEALTH C-3 physician / Study Coordinator is the best resource for more information.

You may also call the Romark Information Center at (877) 925-4642 between the hours of 8.30 AM and 5.30 PM EST for information. Calling a STEALTH C-3 trial center or Romark Laboratories does not place you under any obligation to participate in the STEALTH C-3 clinical trial.

Where are the STEALTH C-3 Study centers located?

The STEALTH C-3 trial centers are run by physicians and study coordinators located at university hospitals, major metropolitan hospitals, research hospitals, and medical centers across the United States.

View a list of U.S. STEALTH C-3 study sites

Speaking to a STEALTH C-3 physician / Study Coordinator is the best resource for more information.

You may also call the Romark Information Center at (877) 925-4642 between the hours of 8.30 AM and 5.30 PM EST for information. Calling a STEALTH C-3 trial center or Romark Laboratories does not place you under any obligation to participate in the STEALTH C-3 clinical trial.

What are the risks in taking part in a clinical study?

Participation in a clinical research study does not guarantee a benefit to the study patient because it is not known whether the investigational drug will be effective in treating the condition being studied.

There are also potential risks including the possibility of unpleasant or serious side effects.

All study patients receive expert medical evaluation and care, and are closely monitored throughout the course of the study.

What is placebo?

A placebo looks exactly the same as the investigational drug but does not contain any drug. STEALTH C-3 is a "blinded" study, which means that neither your STEALTH C-3 doctor nor you will know which group you are in. Both groups will be receiving an oral tablet along with the standard of care therapy. Neither your doctor nor you will know whether the tablet is the investigational drug tablet or the placebo tablet.

What if I get the placebo and not the investigational drug?

If you do not get the investigational drug while participating in the study because you are not randomly assigned to that group, you will still be getting the standard of care treatment (peginterferon and ribavirin). If you were not in the study you would get standard of care treatment, so if you do get standard of care treatment plus placebo your treatment is no different from what you would have had if you were not in this study.

What if I have questions?

A STEALTH C-3 doctor and study team will be happy to answer any questions you may have regarding the study.

For general STEALTH C-3 questions, please call the Information Center at Romark Laboratories at (877) 925-4642 between the hours of 8.30 AM and 5.30 PM EST. For a list of contact information for the STEALTH C3 clinical study sites, click here.

For patients who are already enrolled in STEALTH C-3, please talk to your STEALTH C-3 doctor, study team, or see your informed consent form for information regarding STEALTH C-3 and your participation.