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Randomized, Double Blind Trial of LdT (Telbivudine) versus Lamivudine in Adults with Compensated Chronic Hepatitis B Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Randomized, Double Blind Trial of LdT (Telbivudine) versus Lamivudine in Adults with Compensated Chronic Hepatitis B conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Randomized, Double Blind Trial of LdT (Telbivudine) versus Lamivudine in Adults with Compensated Chronic Hepatitis B Clinical research trials and Randomized, Double Blind Trial of LdT (Telbivudine) versus Lamivudine in Adults with Compensated Chronic Hepatitis B health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Randomized, Double Blind Trial of LdT (Telbivudine) versus Lamivudine in Adults with Compensated Chronic Hepatitis B. Randomized, Double Blind Trial of LdT (Telbivudine) versus Lamivudine in Adults with Compensated Chronic Hepatitis B Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Randomized, Double Blind Trial of LdT (Telbivudine) versus Lamivudine in Adults with Compensated Chronic Hepatitis B clinical trial. Subjects frequently get the best healthcare possible for their Randomized, Double Blind Trial of LdT (Telbivudine) versus Lamivudine in Adults with Compensated Chronic Hepatitis B condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > Randomized, Double Blind Trial of LdT (Telbivudine) versus Lamivudine in Adults with Compensated Chronic Hepatitis B  Randomized, Double Blind Trial of LdT (Telbivudine) versus Lamivudine in Adults with Compensated Chronic Hepatitis B
Randomized, Double Blind Trial of LdT (Telbivudine) versus Lamivudine in Adults with Compensated Chronic Hepatitis B
For Condition: Chronic Hepatitis B
Status: Recruiting
Sponsor(s): Idenix Pharmaceuticals ,
Synopsis: Idenix Pharmaceuticals, Inc is conducting this research study to see if the investigational medication, LdT (Telbivudine), is safe and effective (that is, how well it works by decreasing the level of hepatitis B virus in your blood and improving the condition of your liver) in the treatment of hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking lamivudine, which is a drug currently approved by the Food and Drug Adminstration (FDA) for the treatment of hepatitis B infection.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 16 Years/70 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Chronic Hepatitis B, documented by: Clinical history compatible with chronic HBV, Positive serum HBsAg, HBeAg-positive OR HBeAg-negative, Liver biopsy pre-treatment consistent with chronic HBV - Elevated serum ALT at (> or =1.3–10xULN) - Serum HBV DNA > or =6 log10 copies/mL - Patient willing and able to comply with the study drug regimen and all other study requirements - Patient or guardian has provided written informed consent Exclusion Criteria: - Patient is pregnant or breastfeeding - Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (b-HCG) at Screen - Patient is of childbearing potential and unwilling to use a barrier method of contraception - Patient is co infected with hepatitis C virus (HCV), hepatitis D virus (HDV), HIV-1 or HIV-2. Patients will be tested for antibodies to HCV, HIV, and HDV in the screening assessments performed at the central laboratory - Patient previously received lamivudine or an investigational anti-HBV nucleoside or nucleotide analog at any time - Patient has received interferon or other immunomodulatory treatment for HBV infection in the 12 months before screening for this study - Patient has a medical condition that requires prolonged or frequent use of systemic acyclovir or famciclovir (e.g., for recurrent herpes virus infections, etc) - Patient has a history of ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or other clinical signs of hepatic decompensation - Patient has a history of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC. - Patient is currently abusing alcohol or illicit drugs, or has a history of alcohol abuse or illicit substance abuse within the preceding two years - Patient has a medical condition that requires frequent or prolonged use of systemic corticosteroids - Patient has a medical condition requiring the use of potentially hepatotoxic drugs - Patients who has been on warfarin or other anticoagulants during 30 days prior to screening or if expected during the present study - Patient has one or more additional known primary or secondary causes of liver disease, other than hepatitis B
Total Enrollment: 1200
Location and Contact Information:
Dr. Tuan Research and Education, Inc. *Recruiting*
San Diego, California, 92115
United States
Recruiting
Additional Information:
Study ID Numbers: NV-02B-007;
Study Start Date: February 2003
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00057265
Other Chronic Hepatitis B Studies:
1. A Phase III Study of Entecavir vs Lamivudine in Adults with Chronic Hepatitis B Infection and Positive for Hepatitis B E Antigen
2. Safety and antiviral study of ACH-126, 443 (beta-L-Fd4C) in the treatment of adults with chronic Hepatitis B infection.
3. Efficacy and safety study of Pegasys in the treatment of chronic hepatitis B
4. Lamivudine for Chronic Hepatitis B
5. A Phase III Study of Entecavir vs Lamivudine in Adults with Chronic Hepatitis B Infection and negative for Hepatitis B e Antigen
Related Studies:
Other Chronic Hepatitis B Clinical Trials
Other California Clinical Trials
Other San Diego Clinical Trials
Randomized, Double Blind Trial of LdT (Telbivudine) versus Lamivudine in Adults with Compensated Chronic Hepatitis B
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