Clinical trial NCT00040144: Safety and Antiviral Study of ACH126, 433 (b-L-Fd4C) in Adults With Lamivudine-resistant Chronic Hepatitis B
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Hepatitis B
Keywords: E-Antigen Positive
Lamivudine-resistant Chronic Hepatitis B
Achillion
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Achillion, a wholly owned subsidiary of Alexion
First posted: 2002-06-25
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine the safety and antiviral hepatitis B virus (HBV) activity of ACH126, 433 in the treatment of adults with lamivudine-resistant chronic hepatitis B.

Detailed description: Evaluation of the safety and antiviral activity of 3 dose levels of ACH126, 433 over a 12-week treatment in the population is described.

Eligibility criteria: Inclusion Criteria

* Chronic HBV infection, known to be hepatitis B surface antigen (HbsAg) positive ≥ 6 months
* On lamivudine, either 100 or 150 milligrams daily for the treatment of chronic hepatitis B infection and exhibit a 2-3 log decrease in HBV deoxyribonucleic acid (DNA) levels followed by a rebound of at least 1.5 log HBV DNA or

  * Achieved an HBV DNA level of \< 10,000 copies/milliliter (mL) HBV DNA on at least 2 occasions and have rebounded to \> 100,000 copies/mL HBV DNA, or
  * Have a demonstrable lamivudine -resistant genotype regardless of treatment history.
* Hepatitis B e-antigen positive.
* Human immunodeficiency virus (HIV) negative.
* Serum alanine aminotransferase ≥ 1.5 and ≤ 10x times the upper limit of normal (ULN).
* Hemoglobin ≥ 10 grams/deciliter or hematocrit ≥ 30% (in the absence of blood transfusions or erythropoietin treatment in the preceding 2 weeks).
* Platelet count \>75,000/cubic millimeters (in the absence of ongoing granulocyte colony-stimulating factor therapy).
* Serum creatinine \< 1.1x the ULN.
* Negative radiologic screening test (ultrasound, computerized tomography scan, or magnetic resonance imaging) for hepatocellular carcinoma within 6 months prior to entry.
* Prothrombin time/international normalize ratio \< 2.
* Participants of reproductive capability must utilize an approved form of birth control.
* All women of child-bearing capability must have a negative serum or urine pregnancy test (minimum sensitivity of 24 international units/liter of beta human chorionic gonadotropin) within 72 hours prior to the start of study medication.
* Participants must be able to provide written informed consent.
* Participant 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 participant unsuitable for the study or unable to comply with the dosing requirements.
* Use of any investigational drug.
* Participants with decompensated liver disease.
* Use of any concomitant herbal treatments.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Clinical Trial Site
state: California
city: Orange
country: United States
facility: Clinical Trial Site
state: California
city: Pasadena
country: United States
facility: Clinical Trial Site
state: California
city: San Francisco
country: United States
facility: Clinical Trial Site
state: California
city: Miami
country: United States
facility: Clinical Trial Site
state: Florida
city: Chicago
country: United States
facility: Clinical Trial Site
state: Illinois
city: Chicago
country: United States
facility: Clinical Trial Site
state: Illinois
city: Boston
country: United States
facility: Clinical Trial Site
state: Massachusetts
city: New York
country: United States
facility: Clinical Trial Site
state: New York
city: Dallas
country: United States
facility: Clinical Trial Site
state: Texas
city: Dallas
country: United States
facility: Clinical Trial Site
state: Texas
city: Fairfax
country: United States
facility: Clinical Trial Site
state: Virginia
city: Seattle
country: United States
facility: Clinical Trial Site
state: Washington
city: Vancouver
country: Canada
facility: Clinical Trial Site
state: British Columbia
city: Toronto
country: Canada
facility: Clinical Trial Site
state: Ontario
city: Toronto
country: Canada
facility: Clinical Trial Site
state: Ontario
city: Montréal
country: Canada
facility: Clinical Trial Site
state: Quebec
city: Hong Kong
country: China
facility: Clinical Trial Site
Study officials:
References: