NCT00040144

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2002

Shorter than P25 for phase_2

Geographic Reach
3 countries

18 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2002

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 25, 2002

Completed
6 days until next milestone

Study Start

First participant enrolled

July 1, 2002

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

First QC Date

June 21, 2002

Last Update Submit

February 16, 2021

Conditions

Chronic Hepatitis B

Keywords

E-Antigen PositiveLamivudine-resistant Chronic Hepatitis BAchillion

Interventions

ACH126, 433DRUG
Also known as: b-L-Fd4C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • +1 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Clinical Trial Site

Los Angeles, California, 90048, United States

Location

Clinical Trial Site

Orange, California, 92868, United States

Location

Clinical Trial Site

Pasadena, California, 91105, United States

Location

Clinical Trial Site

San Francisco, California, 94143, United States

Location

Clinical Trial Site

Miami, Florida, 33136, United States

Location

Clinical Trial Site

Chicago, Illinois, 60612, United States

Location

Clinical Trial Site

Chicago, Illinois, 60637, United States

Location

Clinical Trial Site

Boston, Massachusetts, 02215, United States

Location

Clinical Trial Site

New York, New York, 10021, United States

Location

Clinical Trial Site

Dallas, Texas, 75246, United States

Location

Clinical Trial Site

Dallas, Texas, 75390, United States

Location

Clinical Trial Site

Fairfax, Virginia, 22031, United States

Location

Clinical Trial Site

Seattle, Washington, 98195, United States

Location

Clinical Trial Site

Vancouver, British Columbia, V5Z 1L5, Canada

Location

Clinical Trial Site

Toronto, Ontario, M5G 2C4, Canada

Location

Clinical Trial Site

Toronto, Ontario, M5T 2S8, Canada

Location

Clinical Trial Site

Montreal, Quebec, H2X 3J4, Canada

Location

Clinical Trial Site

Hong Kong, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

dexelvucitabine

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2002

First Posted

June 25, 2002

Study Start

July 1, 2002

Study Completion

May 1, 2003

Last Updated

February 18, 2021

Record last verified: 2021-02

Locations

US(13)CA(4)CN(1)