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| Sponsor: | Achillion Pharmaceuticals |
|---|---|
| Information provided by: | Achillion Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00040144 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Hepatitis B |
Drug: ACH126, 433 (b-L-Fd4C) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Safety and Efficacy of 12 Weeks Oral Treatment With ACH126, 433 (b-L-Fd4C) in Adults With Lamivudine-resistant Chronic Hepatitis B |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exhibit a 2-3 log decrease in HBV DNA levels followed by a rebound of at least 1.5 log HBV DNA or
Exclusion Criteria
Contacts and Locations| United States, California | |
| Cedars Sinai Medical Center | |
| Los Angeles, California, United States, 90048 | |
| University of California-Irvine | |
| Orange, California, United States, 92868 | |
| Huntington Memorial Hospital | |
| Pasadena, California, United States, 91105 | |
| University of California-San Francisco | |
| San Francisco, California, United States, 94143-0538 | |
| United States, Florida | |
| University of Miami | |
| Miami, Florida, United States, 33136 | |
| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| University of Illinois at Chicago | |
| Chicago, Illinois, United States, 60612-7323 | |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| United States, New York | |
| Cornell Weill Medical College | |
| New York, New York, United States, 10021 | |
| United States, Texas | |
| The University of Texas | |
| Dallas, Texas, United States, 75390 | |
| Baylor Universtiy Medical Center | |
| Dallas, Texas, United States, 75246 | |
| Southwest Infectious Disease Associates, P.A. | |
| Dallas, Texas, United States, 75246 | |
| United States, Virginia | |
| Metropolitan Research | |
| Fairfax, Virginia, United States, 22031 | |
| United States, Washington | |
| Unviversity of Washington | |
| Seattle, Washington, United States, 98195 | |
| Canada, British Columbia | |
| Vancouver General Hospital | |
| Vancouver, British Columbia, Canada, V5Z 1L5 | |
| Canada, Ontario | |
| Toronto General Hospital | |
| Toronto, Ontario, Canada, M5G 2C4 | |
| Toronto Western Hospital | |
| Toronto, Ontario, Canada, M5T 2S8 | |
| Canada, Quebec | |
| University of Montreal | |
| Montreal, Quebec, Canada, H2X 3J4 | |
| China | |
| The University of Hong Kong | |
| Hong Kong SAR, China | |
More Information
| ClinicalTrials.gov Identifier: | NCT00040144 History of Changes |
| Other Study ID Numbers: | ACH443-005 |
| Study First Received: | June 21, 2002 |
| Last Updated: | August 18, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
E-Antigen positive, Lamivudine-Resistant Chronic Hepatitis B, Achillion |
|
Hepatitis Hepatitis A Hepatitis B Hepatitis, Chronic Hepatitis B, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections |
DNA Virus Infections Lamivudine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |