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

Tracking Information
First Received Date ^ICMJE	June 21, 2002
Last Updated Date	August 18, 2009
Start Date ^ICMJE	July 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00040144 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Safety and Antiviral Study of ACH126, 433 (b-L-Fd4C) in Adults With Lamivudine-resistant Chronic Hepatitis B
Official Title ^ICMJE	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
Brief Summary	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.
Detailed Description	Evaluation of safety and antiviral activity of 3 dose levels of ACH126, 443 over a twelve week treatment in the population described.
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Chronic Hepatitis B
Intervention ^ICMJE	Drug: ACH126, 433 (b-L-Fd4C)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	85
Completion Date	May 2003
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Canada, China

Administrative Information
NCT ID ^ICMJE	NCT00040144
Responsible Party
Study ID Numbers ^ICMJE	ACH443-005
Study Sponsor ^ICMJE	Achillion Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Achillion Pharmaceuticals
Verification Date	August 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP