Information About Clinical Trials

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Information About  
Clinical Trials
  
  
  Hepatitis B Foundation Clinical Trials
www.hepb.org/clinicalinfo.html

Centerwatch Clinical Trials
http://www.centerwatch.com/studies/cat79.htm

National Institutes of Health Clinical Trials
http://clinicaltrials.gov


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Clinical Trials Seeking Patients

January 2003



SPECIAL NOTICE!
Patient Assistance for Hepsera (adefovir dipivoxil)
Gilead has established a U.S. Patient Assistance Program for people who do not have insurance or cannot afford to pay for treatment with Hepsera. Similar programs are in place in Australia, Canada and many countries in Europe and will continue until the drug is commercially available in those areas. For more information about the Patient Assistance Program in the U.S., please call 1-800-GILEAD-5 or

1-650-574-3000



Open Enrollment for Phase III Trials of Entecavir
Bristol-Myers Squibb (BMS) is conducting studies of this once daily oral drug in approximately 130 sites in more than 30 countries worldwide. Three different studies are being conducted based on the results of patients’ serological status (hepatitis B e-antigen positive or negative), and whether the patient is currently on lamivudine therapy and has evidence of resistance to lamivudine. Patients will be randomized to receive either entecavir or standard therapy with lamivudine. Neither the patient nor the doctor will be aware of which treatment the patient is receiving. After completing the study, all participants will be monitored periodically for up to 5 years for survival and incidence of HBV-related complications. Location and Contact Information or contact: Bristol-Myers Squibb Call Center,  1-866-892-1BMS



Open enrollment for Phase III trial of LdT (telbivudine)
Idenix Pharmaceuticals Inc. is sponsoring a phase III clinical trial of LdT for treatment of chronic hepatitis B. This trial will be conducted at over 100 sites in North America, Asia, Europe, Australia, and New Zealand. Patients must be adults with chronic hepatitis B who have never have been treated with lamivudine or other nucleoside or nucleotide analogues. Patients will be randomized to receive either LdT or lamivudine for 2 years, and neither the patient nor the doctor will know which treatment the patient has received until the end of the study. Contact: Barbara Fielman at 617-250-3100.



Open Enrollment for Phase II Trial
Of ACH-126, 433 for Lamivudine-Resistant HBV
The purpose of this study is to evaluate the safety and antiviral activity of 3-dose levels of ACH-126, 443 over a twelve-week treatment of adults with lamivudine-resistant chronic HBV. Patients 18 years and older with chronic HBV longer than six months may be eligible to participate. Studies are being conducted in the U.S., Canada, and Hong Kong.

Location and Contact Information

Contact: John Pottage, MD, at: 203-624-7000 ([email protected])



Open Enrollment for Phase II Trial of Clevudine
The purpose of the study is to evaluate the safety and effectiveness of 12 weeks of treatment with clevudine, at one of three doses (10 mg, 30 mg, or 50 mg), in patients chronically infected with hepatitis B virus. U.S. studies are being conducted in Philadelphia, PA and Chicago, IL. Additional countries include Canada, China, France and Singapore. Location and Contact Information.



Columbia-Presbyterian Medical Center Studies Adefovir Dipivoxil
Comparison of adefovir dipivoxil to placebo for the treatment of adults with eAg+ chronic HBV. Those treated within 6 months or involved in an investigational drug trial two months prior to this study will be ineligible to participate.
Contact: Ms. Cabilia Gomez 212-305-3839

Columbia-Presbyterian Medical Center Studies Entecavir
The safety of Entecavir (BMS 200,475) will be evaluated in adults with chronic HBV. Those co-infected with HIV are not eligible to participate.
Contact: Ms. Cabilia Gomez 212-305-3839.



NIH Sponsors Phase II Comparison of Treatments of Co-Infected HIV/HBV Subjects  

The purpose of this study is to find out if adding adefovir (ADV) or tenofovir (TDF) with lamivudine 3TC) has an effect on HBV infection, and to study the tolerability and safety of the drugs. This study will compare the combination of ADV and 3TC with the combination of TDF and 3TC to determine which drug combination is most effective in people who are infected with both HBV and HIV. The Institute of Allergy and Infectious Diseases (NIAID) is sponsoring this study at 11 sites across the country. Contact the NIH Patient Recruitment and Public Liaison Office at 1-800-411-1222 or [email protected]



NIH Sponsors Adefovir plus Lamivudine HBV Trials: With or Without HIV
Patients 18 years of age or older with active HBV despite treatment with lamivudine for at least 1 year may be eligible for this 48-week study. Patients with or without HIV infection may participate. Patients will be randomized to two treatment groups. One group will take 10 milligrams/day of adefovir by mouth, and the other will take a placebo. Both groups will also take 150 mg lamivudine by mouth. Patients with HIV infection will continue to take antiretroviral therapy as well. Contact the NIH Patient Recruitment and Public Liaison Office at 1-800-411-1222 or [email protected]



NIH Sponsors Lamivudine and Adefovir Clinical Trials
This study will test whether the combination of lamivudine and adefovir is better than adefovir alone for the treatment of chronic hepatitis B. Patients 18 years of age and older, who have been infected with HBV for at least 6 months, may be eligible for this study. Candidates may not have received lamivudine treatment in the past 6 months or prior treatment with adefovir and must not be taking other anti-viral treatments for their hepatitis. Patients will be randomized to begin taking 100 milligrams/day of lamivudine and 10 mg/day of adefovir, both in pill form or 10 mg of adefovir alone for at least 12 months. Contact the NIH Patient Recruitment and Public Liaison Office at 1-800-411-1222 or [email protected]


NIAID Sponsors Trial for Lamivudine-Resistant Hepatitis B and HIV Co-infection
This phase II study is now recruiting patients. The study will compare the combination of adefovir dipivoxil and lamivudine with tenofovir disoproxil fumarate and lamivudine, to determine which drug combination is most effective in people who are co-infected with both HBV and HIV.  For more information, please contact a study location in the US: University of California at San Francisco (415-514-0550), University of Colorado Health Sciences Center (303-372-5535), Northwestern University Medical School (312-695-5012), University of North Carolina at Chapel Hill (919-843-8761), the University of Cincinnati (513-584-8373), or the University of Texas at Galveston (409-747-0241).  

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How Do I Enroll in Clinical Trials?

(B-Informed, Spring 2000, issue number 28, page 7)

Recently, the government opened a comprehensive database (www.clinicaltrials.gov) listing the thousands of clinical trials on experimental drugs and therapies targeting a range of a diseases-including hepatitis B—to help link up sick patients with study centers throughout the country. The site joins the growing list of Internet sites such as www.centerwatch.com, a commercial site listing both NIH and pharmaceutical/biotech-sponsored trials around the world.  

These easy-to-use sites should help widen the pool of eligible candidates and bring us a step closer to a cure, according to Robert Brown, M.D., medical director of the Center for Liver Disease and Transplantation at Columbia-Presbyterian University in New York City. “If we are to move forward on finding a cure for Hepatitis B, we need patients to move forward and become part of the testing of experimental drugs,” he says.

Advantages to participating in a study include access to the latest advancements and “close monitoring by an expert specializing in liver diseases at a leading health care facility,” says Dr. Brown. Expensive blood work and clinical monitoring are normally free of charge. Some trials even pay you to participate.

Whether you log onto the web sites above or talk to your doctor, be sure you understand the who, what, where, when and how of clinical trials.  

For starters, you should know that all people who enroll in clinical trials are volunteers and are carefully screened and must meet specific criteria to be eligible. There are four stages that a new drug must go through before being approved by the Food and Drug Administration (FDA):

Phase I clinical trials test new treatments in small groups of people (20-80) to evaluate safety, determine dosage and identify side effects. Phase II trials test the drug on 100-300 people to further evaluate its safety and effectiveness. Phase III studies test the drug on 1000-3000 people to confirm its effectiveness, monitor side effects and compare it to commonly used treatments. Phase IV studies are done after the drug or treatment has been marketed to collect information about its effect in various populations and any side effect associated with long-term use.  

A blinded or masked study means the participants do not know whether they are in the experimental or control group (the group given an inactive placebo). In a double- blind study, neither the participants nor the study staff know which participants are in the experimental or control group.  

Enlist your doctor to help you sift through all the information about trials and weigh the pros and cons. “Make sure you are clear about whether the drug being tested is better – or riskier – for you than no or existing treatment,” says Dr. Brown. Remember that you’ll continue to work with your primary health care provider if you participate in a trial and you can drop out of a trial at any time, he adds. Find out who is financing the study (i.e., the NIH, pharmaceutical companies, individual physician-investigators, or HMOs). Keep in mind that major medical centers that test drugs have the primary goal of research on the disease rather than the drug, says Dr. Brown.  

Take along a friend or family member when you meet the researchers as they go over the information in the box below. Make sure you are clear about whether the drug being tested is better, or riskier, for you than no or existing treatment.
10 Questions to Ask Your Doctor Before Enrolling

in a Clinical Trial:

1. Where is the site located and how often will I need to go there?

2. Will I be charged for any part of the trial or will my insurance pay for it?

3. Why do researchers think the treatment will work better than standard (FDA-approved) treatment?

4. What tests or procedures are involved and how are patients safely monitored while on the treatment?

5. How many people have tested the drug and what has happened to them?

6. What are the possible short and long-term side effects?

7. Who is most likely to benefit from this drug and what criteria have been associated with success?

8.  What happens to my HBV when I stop taking the drug?

9.  What is the follow-up care after the clinical trial ends?

10. If this drug does not work for me, am I eligible to try another one?