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Safety and antiviral activity study of ACH-126,443 (beta-L-Fd4C) in treatment naive adults with chronic Hepatitis B Virus infection Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Safety and antiviral activity study of ACH-126,443 (beta-L-Fd4C) in treatment naive adults with chronic Hepatitis B Virus infection conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Safety and antiviral activity study of ACH-126,443 (beta-L-Fd4C) in treatment naive adults with chronic Hepatitis B Virus infection Clinical research trials and Safety and antiviral activity study of ACH-126,443 (beta-L-Fd4C) in treatment naive adults with chronic Hepatitis B Virus infection healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Safety and antiviral activity study of ACH-126,443 (beta-L-Fd4C) in treatment naive adults with chronic Hepatitis B Virus infection. Safety and antiviral activity study of ACH-126,443 (beta-L-Fd4C) in treatment naive adults with chronic Hepatitis B Virus infection Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Safety and antiviral activity study of ACH-126,443 (beta-L-Fd4C) in treatment naive adults with chronic Hepatitis B Virus infection clinical trial. Subjects frequently obtain the most expert healthcare possible for their Safety and antiviral activity study of ACH-126,443 (beta-L-Fd4C) in treatment naive adults with chronic Hepatitis B Virus infection condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Safety and antiviral activity study of ACH-126,443 (beta-L-Fd4C) in treatment naive adults with chronic Hepatitis B Virus infection  Safety and antiviral activity study of ACH-126,443 (beta-L-Fd4C) in treatment naive adults with chronic Hepatitis B Virus infection
Safety and antiviral activity study of ACH-126,443 (beta-L-Fd4C) in treatment naive adults with chronic Hepatitis B Virus infection
For Condition: Hepatitis B, Chronic
Status: Completed
Sponsor(s): Achillion Pharmaceuticals ,
Synopsis: The purpose of this study is to determine the safety and anti-HBV activity of ACH-126, 443 (beta-L-Fd4C) in comparison to lamivudine or placebo in treatment naive adults with chronic Hepatitis B infection.
Details: Evaluation of safety and antiviral activity of 3 dose levels of ACH-126, 443 vs. lamivudine and placebo over 12 weeks of treatment in the population described.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Adults >= 18 years of age - Chronic HBV infection, known to be HbsAg positive >= 6 months - Plasma HBV DNA level >= 100,000 copies/mL - HBe-antigen positive - HIV negative - Basic hematologic and chemistry parameters within acceptable limits (defined in protocol - No need for excluded medications - Subjects of reproductive capability must utilize two approved forms of birth control, one of which must be barrier protection. Exclusion Criteria: - HIV infection - Hepatitis C co-infection - Concurrent systemic antiviral treatment - Previous antiviral treatment for HBV infection within 6 months prior to randomization or treatment with 3TC for more than 6 months at any time in the past - Previous therapy with agents with significant systemic myelosuppressive or cytotoxic potential within 3 months of study start or the expected need for such therapy at study start - Alcohol abuse - Pregnancy or breast-feeding - Inability to tolerate oral medication - AST>7.0 times the upper limit of normal - ALT>7.0 times the upper limit of normal - Any clinical condition or prior therapy that, in the Investigators opinion, would make the subject unsuitable for the study or unable to comply with the dosing requirements - Use of any investigational drug.
Total Enrollment: 120
Location and Contact Information:
Overall Study Official:
LisaDunkle, , Achillion Pharmaceuticals
Clinic Center of Serbia, Institute of Infectious Disease
Belgrade, ,
Yugoslavia
Foundation of Gastroenterology
Sofia, ,
Bulgaria
Clinic of Gastroenterology
Sofia, ,
Bulgaria
Clinic of Novi Sad
Novi Sad, ,
Yugoslavia
Clinic of Gastroenterology
Sofia, ,
Bulgaria
Additional Information:
Study ID Numbers: ACH443-003;
Study Start Date: February 2002
Record last reviewed: September 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00034359
Other Hepatitis B, Chronic Studies:
1. Safety and antiviral activity study of ACH-126,443 (beta-L-Fd4C) in treatment naive adults with chronic Hepatitis B Virus infection
2. Telbivudine versus Lamivudine in Adults with Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
Related Studies:
Other Hepatitis B, Chronic Clinical Trials
Other Clinical Trials
Other Sofia Clinical Trials
Safety and antiviral activity study of ACH-126,443 (beta-L-Fd4C) in treatment naive adults with chronic Hepatitis B Virus infection
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