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Safety and Antiviral Study of ACH126, 433 (b-L-Fd4C) in Adults With Lamivudine-resistant Chronic Hepatitis B

This study has been terminated.
(Safety concerns)
Sponsor:
Information provided by:
Achillion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00040144
First received: June 21, 2002
Last updated: August 18, 2009
Last verified: August 2009
  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 2

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

Resource links provided by NLM:


Further study details as provided by Achillion Pharmaceuticals:

Estimated Enrollment: 85
Study Start Date: July 2002
Study Completion Date: May 2003
Detailed Description:

Evaluation of safety and antiviral activity of 3 dose levels of ACH126, 443 over a twelve week treatment in the population described.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00040144

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
Baylor Universtiy Medical Center
Dallas, Texas, United States, 75246
Southwest Infectious Disease Associates, P.A.
Dallas, Texas, United States, 75246
The University of Texas
Dallas, Texas, United States, 75390
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
Sponsors and Collaborators
Achillion Pharmaceuticals
  More Information

Additional Information:
No publications provided

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

Keywords provided by Achillion Pharmaceuticals:
E-Antigen positive,
Lamivudine-Resistant Chronic Hepatitis B,
Achillion

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Lamivudine
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014