NCT00095121

Brief Summary

The purpose of this study is to investigate the efficacy and safety of adefovir dipivoxil for the treatment of chronic hepatitis B in children and adolescents (age 2 to less than 18 years) following 48 weeks of placebo-controlled, double-blind treatment and following an additional 192 weeks of open-label adefovir dipivoxil treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
173

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2004

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2004

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 1, 2004

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 3, 2011

Completed
Last Updated

May 22, 2012

Status Verified

May 1, 2012

Enrollment Period

1.9 years

First QC Date

October 29, 2004

Results QC Date

April 8, 2011

Last Update Submit

May 16, 2012

Conditions

Chronic Hepatitis B

Keywords

Hepatitis BChildrenPediatricAdefovir Dipivoxil

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) < 1000 Copies/mL (Polymerase Chain Reaction [PCR]-Based Assay) and Normal Alanine Aminotransferase (ALT) at Week 48 (Missing = Failure)

    In the absence of biopsy data from these pediatric participants, this endpoint enables assessments of drug effect on viral replication and the underlying degree of inflammation in the liver.

    Week 48

Secondary Outcomes (21)

  • Percentage of Participants With Serum HBV DNA < 1000 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Baseline)

    ADV baseline

  • Percentage of Participants With Serum HBV DNA < 1000 Copies/mL (PCR-based Assay) While on Treatment - Missing = Failure) (ADV Week 192)

    ADV Week 192

  • Percentage of Participants With Serum HBV DNA < 1000 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Week 240)

    ADV Week 240

  • Percentage of Participants With Serum HBV DNA < 400 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Baseline)

    ADV baseline

  • Percentage of Participants With Serum HBV DNA < 400 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Week 192)

    ADV Week 192

  • +16 more secondary outcomes

Study Arms (2)

Placebo (PLB)

PLACEBO COMPARATOR

Participants randomized to receive placebo received placebo during the first 48 weeks of treatment (double-blind phase) and then all eligible participants were administered open-label ADV for the remainder of the study.

Drug: Placebo (PLB)Drug: Lamivudine

Adefovir Dipivoxil (ADV)

EXPERIMENTAL

Participants randomized to receive ADV received ADV during the first 48 weeks of treatment (double-blind phase) and then all eligible participants were administered open-label ADV for the remainder of the study.

Drug: Adefovir Dipivoxil (ADV)Drug: Lamivudine

Interventions

Placebo (PLB)DRUG

Matching placebo

Placebo (PLB)
Adefovir Dipivoxil (ADV)DRUG

10-mg tablet or 2-mg/mL oral suspension

Adefovir Dipivoxil (ADV)
LamivudineDRUG

100-mg tablet administered according to package labeling. Lamivudine was to be added to the open-label ADV regimen of subjects with a serum HBV DNA concentration \>= 1000 copies/mL at 2 consecutive study visits at or after Study Week 96. If the HBV DNA concentration remained \>= 1000 copies/mL at 2 consecutive study visits after the addition of lamivudine, the investigator was required to discontinue all study drugs, perform the early termination ssessments, and have the subject return every 4 weeks for 16 weeks of posttreatment evaluations.

Adefovir Dipivoxil (ADV)Placebo (PLB)

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Positive HBsAg \>= 6 months prior to randomization and positive HBeAg at screening.
  • Serum HBV DNA greater than or equal to 1 x 100,000 copies/mL (PCR assay) at initial or confirmatory screening visit.
  • Serum ALT levels greater than or equal to 1.5 x ULN at both initial and confirmatory screening visits.
  • Compensated liver disease with anticipated survival greater than 12 months and with the following laboratory and clinical parameters within 4 weeks of baseline: \*Prothrombin time less than or equal to 1 second above normal range. \*Total bilirubin less than 1.3 mg/dL or normal direct bilirubin. \*Serum albumin greater than 3 g/dL (greater than 30 g/L). \*No clinical history of ascites, variceal bleeding, encephalopathy or splenomegaly. \*Adequate renal function defined as creatinine clearance greater than or equal to 80 mL/min (calculated using Schwartz Formula).

You may not qualify if:

  • Received immunoglobulin, interferon or lamivudine therapy within 6 months prior to initial screening visit.
  • Participated in any investigational trial with any investigational compound within 2 months prior to initial screening.
  • Organ or bone marrow transplant recipients.
  • Clinical evidence of decompensated liver disease.
  • A Child-Pugh-Turcotte score greater than 6.
  • Inability to comply with study requirements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Boston, Massachusetts, United States

Location

Related Publications (1)

  • Sokal, E, Kelly, D, et al. The Pharmacokinetics (PK) and Safety of a Single Dose of Adefovir Dipivoxil (ADV) in Children and Adolescents (Aged 2-17) with Chronic Hepatitis B. JHepatol,Vol 40(Suppl 1), P. 132, 2004.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Hepatitis B, ChronicHepatitis B

Interventions

adefovir dipivoxilLamivudine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosides

Results Point of Contact

Title
John Flaherty, PharmD, Director, Clinical Research
Organization
Gilead Sciences
John.Flaherty@gilead.com
650-522-5592

Study Officials

  • John Flaherty, PharmD

    Gilead Sciences

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2004

First Posted

November 1, 2004

Study Start

June 1, 2004

Primary Completion

May 1, 2006

Study Completion

April 1, 2010

Last Updated

May 22, 2012

Results First Posted

June 3, 2011

Record last verified: 2012-05

Locations

US(1)