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Safety and antiviral study of ACH126, 433 (b-L-Fd4C) in adults with lamivudine-resistant chronic hepatitis B Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Safety and antiviral study of ACH126, 433 (b-L-Fd4C) in adults with lamivudine-resistant chronic hepatitis B conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Safety and antiviral study of ACH126, 433 (b-L-Fd4C) in adults with lamivudine-resistant chronic hepatitis B Clinical research trials and Safety and antiviral study of ACH126, 433 (b-L-Fd4C) in adults with lamivudine-resistant chronic hepatitis B medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Safety and antiviral study of ACH126, 433 (b-L-Fd4C) in adults with lamivudine-resistant chronic hepatitis B. Safety and antiviral study of ACH126, 433 (b-L-Fd4C) in adults with lamivudine-resistant chronic hepatitis B Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Safety and antiviral study of ACH126, 433 (b-L-Fd4C) in adults with lamivudine-resistant chronic hepatitis B clinical trial. Subjects often receive the most expert healthcare possible for their Safety and antiviral study of ACH126, 433 (b-L-Fd4C) in adults with lamivudine-resistant chronic hepatitis B condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Safety and antiviral study of ACH126, 433 (b-L-Fd4C) in adults with lamivudine-resistant chronic hepatitis B  Safety and antiviral study of ACH126, 433 (b-L-Fd4C) in adults with lamivudine-resistant chronic hepatitis B
Safety and antiviral study of ACH126, 433 (b-L-Fd4C) in adults with lamivudine-resistant chronic hepatitis B
For Condition: Chronic Hepatitis B
Status: No longer recruiting
Sponsor(s): Achillion Pharmaceuticals ,
Synopsis: The purpose of this study is to determine the safety and antiviral HBV activity of ACH126, 433 (b-L-Fd4C) in the treatment of adults with lamivudine-resistant chronic Hepatitis B.
Details: Evaluation of safety and antiviral activity of 3 dose levels of ACH126, 443 over a twelve week 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 - On lamivudine, either 100 or 150 mg daily for the treatment of chronic hepatitis B infection and - Exhibit a 2-3 log decrease in HBV DNA levels followed by a rebound of at least 1.5 log HBV DNA or - Achieved an HBV DNA level of <10,000 copies/mL HBV DNA on at least 2 occasions and have rebounded to > 100,000 copies/mL HBV DNA, or - Have a demonstrable 3TC resistant genotype regardless of treatment history. - HBeAG positive - HIV negative - Serum ALT 1.5 and 10x times upper limit of normal - HGB 10g/dl or HCT 30% (in the absence of blood transfusions or erythropoietin treatment in the preceding two weeks) - Platelet count >75,000/mm(^3), (in the absence of ongoing G-CSF therapy) - Serum creatinine <1.1 times upper limit of normal (ULN) - Negative radiologic screening test (ultrasound, CT scan or MRI) for hepatocellular carcinoma (HCC) within 6 months prior to entry - PT/INR<2 - Subjects of reproductive capability must utilize an approved forms of birth control - All women of child-bearing capability must have a negative serum or urine pregnancy test (minimum sensitivity of 24 IU/L of b-HCG) within 72 hours prior to the start of study medication - Subjects must be able to provide written informed consent - Subject must be available for follow-up for a period of 20 weeks Exclusion Criteria - HIV infection - Hepatitis C co-infection - Alcohol abuse - Pregnancy or breast-feeding - Inability to tolerate oral medication - Any clinical condition or prior therapy that, in the Investigator’s opinion, would make the subject unsuitable for the study or unable to comply with the dosing requirements - Use of any investigational drug - Patients with decompensated liver disease - Use of any concomitant herbal treatments
Total Enrollment: 85
Location and Contact Information:
University of Montreal
Montreal, Quebec, H2X 3J4
Canada
The University of Texas
Dallas, Texas, 75390
United States
Huntington Memorial Hospital
Pasadena, California, 91105
United States
Metropolitan Research
Fairfax, Virginia, 22031
United States
University of California-Irvine
Orange, California, 92868
United States
Cedars Sinai Medical Center
Los Angeles, California, 90048
United States
Southwest Infectious Disease Associates, P.A.
Dallas, Texas, 75246
United States
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Canada
Baylor Universtiy Medical Center
Dallas, Texas, 75246
United States
University of California-San Francisco
San Francisco, California, 94143-0538
United States
The University of Hong Kong
Hong Kong SAR, ,
China
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1L5
Canada
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
University of Illinois at Chicago
Chicago, Illinois, 60612-7323
United States
Unviversity of Washington
Seattle, Washington, 98195
United States
University of Chicago
Chicago, Illinois, 60637
United States
Cornell Weill Medical College
New York City, New York, 10021
United States
University of Miami
Miami, Florida, 33136
United States
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Canada
Additional Information:
Study ID Numbers: ACH443-005;
Study Start Date: July 2002
Record last reviewed: September 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00040144
Other Chronic Hepatitis B Studies:
1. Efficacy and safety study of Pegasys in the treatment of chronic hepatitis B
2. A Phase III Study of Entecavir vs Lamivudine in Chronic Hepatitis B Subjects with Incomplete Response to Lamivudine
3. A Phase III Study of Entecavir vs Lamivudine in Adults with Chronic Hepatitis B Infection and negative for Hepatitis B e Antigen
4. An Open-Label Program of Adefovir Dipivoxil in the Treatment of Patients with Lamivudine-Resistant Chronic Hepatitis B With Limited Treatment Options
5. Lamivudine for Chronic Hepatitis B
Related Studies:
Other Chronic Hepatitis B Clinical Trials
Other Texas Clinical Trials
Other Dallas Clinical Trials
Safety and antiviral study of ACH126, 433 (b-L-Fd4C) in adults with lamivudine-resistant chronic hepatitis B
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