Open Clinical Trials for Patients with Chronic Hepatitis B

More than a dozen new clinical trials for people with chronic hepatitis B are currently open for enrollment. The Hepatitis B Foundation provides regular updates on the most current hepatitis B clinical trials in the United States and abroad. Contact the Foundation (email info@hepb.org; phone 215-489-4900) if you have questions about clinical trials or know of a drug trial that is not listed. Many more hepatitis B trials can be located through the U.S. government’s clinical trials web site at www.clinicaltrials.gov.

Comparison of Telbivudine (LdT) and Lamivudine in Decompensated HBV and Cirrhosis
Comparison study of Telbivudine (LdT) and lamivudine (3TC, Epivir). Principal Investigator is Dr. Ray Kim, Mayo Clinic, Rochester, MN. Contact Sharleen Cartney at 507-266-8493.

Comparison of Tenofovir (TDF), Emtricitabine/TDF, and Entecavir in Decompensated HBV
To evaluate and compare the safety and tolerability of three oral antivirals in the treatment of hepatitis B patients with decompensated liver disease. Contact Dr. Cary Moxham of Gilead at cary.moxham@gilead.com or call 919-493-5980, ext. 7102.

Comparison of the Safety of Immediately Switching from Lamivudine to Adefovir vs. Overlapping Lamivudine and Adefovir for 12 Weeks Before Instituting Adefovir Monotherapy in Patients with HBV
Comparison of the safety of directly switching from lamivudine to adefovir (Hepsera) compared with taking the two drugs together for 12 weeks. Principal Investigator is Dr. Hie-Won Hann, Thomas Jefferson University Hospital, Philadelphia, PA. Contact Meejin Ahn at meejin.ahn@jefferson.edu or call 215-955-5806.

FibroScan in Patients with Hepatitis B and C Presenting for Liver Biopsy
To examine the effectiveness of the FibroScan device (a noninvasive technique that measures the elasticity or stiffness of the liver) in differentiating fibrosis in patients who are scheduled to have a liver biopsy. Sites in Boston, MA; Durham, NC; and St. Louis, MO. Contact Dr. Nezam H Afdhal at nafdhal@bidmc.harvard.edu or call 617-632-1118   

Switching from Lamivudine to Telbivudine vs. Continued Lamivudine
To compare the safety and effectiveness of switching HBV treatment from lamivudine to telbivudine (LdT) against continued lamivudine treatment. Contact: Paige Stowers of Idenix at stowers.page@idenix.com or call 617-995-9819.

Adefovir vs. Adefovir Plus Lamivudine for HBV Patients with Normal ALT
A randomized, open-label trial of adefovir dipivoxil (Hepsera) and lamivudine combination therapy vs. adefovir dipivoxil monotherapy. Contact: Dr. Chia C. Wang, University of Washington, at chiaw@u.washington.edu or call 206 731-4511.

4-Methylumbelliferone as a Treatment for Chronic HBV/HCV
Open-label studies, anecdotal reports, and in vitro scientific research suggest that 4-methylumbelliferone (active ingredient of the dietary supplement Heparvit) may prevent and/or reverse the symptoms and complications of chronic HBV and HCV. This study started in September 2005. Contact: Dr. Charles Leach, University of Texas Health Science Center at San Antonio, at leachc@uthscsa.edu or call 210-567-5250.

Telbivudine in Adults Previously Treated in Idenix-Sponsored Telbivudine Studies
An open-label, extended-term study for patients with chronic hepatitis B who have previously completed an Idenix-sponsored trial with telbivudine. Contact: Deborah Lloyd, Idenix, at Lloyd.Deborah@idenix.com or call 617-995-9811.

Phase III HBV Clinical Trials of Tenofovir vs. Adefovir For HBeAg-Positive Patient

Patients will either receive tenofovir or the approved hepatitis B therapy adefovir. Study started in May 2005 with sites in the US, Bulgaria, Canada, France and Germany. Contact: Cary Moxham, PhD, at cary.moxham@gilead.com or call 919-493-5980, ext. 7102

Long-Term Lamivudine Therapy for Chronic Hepatitis B
To evaluate the long-term efficacy and safety of lamivudine therapy and the possibility of stopping therapy in patients with chronic hepatitis B who have a sustained response to treatment. Patients 18 years and older who are being treated with lamivudine may be eligible to participate. Study started in July 2005. Contact: NIH Patient Recruitment and Public Liaison at 800-411-1222.

Entecavir for Chronic HBV: Early Access Program
To provide entecavir to HBV patients who have failed or who have demonstrated intolerance of marketed therapies or for those in whom use of these agents is contraindicated and who have no other available treatment options. Contact: Bristol-Myers Squibb toll-free at 866-892-1BMS, ext. 150.

Lamivudine and Adefovir vs. Adefovir to Treat Chronic Hepatitis B
An NIH study to evaluate lamivudine plus adefovir vs. adefovir alone. Candidates may not have received lamivudine treatment in the past six months or prior treatment with adefovir, and must not be taking other antiviral treatments for their hepatitis. Contact: NIH Patient Recruitment at prpl@mail.cc.nih.gov or call 800.411.1222.

Telbivudine versus Lamivudine in Adults with Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
To study telbivudine vs. lamivudine in the treatment of patients with decompensated hepatitis B over two years. Contact: Gloria Dubuc at
dubuc.gloria@idenix.com or call 617.995.9814.

Comparison of Entecavir vs. Adefovir in Chronic HBV Patients with Hepatic Decompensation
A Phase IIIb comparative study of entecavir vs. adefovir for up to 96 weeks in people with decompensated hepatitis. Study started in July 2003 with sites located in the U.S. and abroad. Contact: Bristol-Myers Squibb toll-free at 866.892.1BMS.

Prevention of Recurrent HBV after Liver Transplantation
Eligible patients for this study must be on a liver transplant waiting list or have already received a liver transplant due to hepatitis B. HBV immune globulin (HBIG), lamivudine (Epivir-HBV), and adefovir (Hepsera) will be evaluated. Contact: Doug Armstrong, U. of Michigan Medical Center, at darms@umich.edu or call 734-936-1712.

07/11/06

Source 
Hepatitis B Foundation: www.hepB.org