Chronic Hepatitis BPhase 3NCT00095121

Safety and Efficacy of Adefovir Dipivoxil in Children and Adolescents With Chronic Hepatitis B

A Phase 3 study testing Adefovir Dipivoxil (ADV) and Lamivudine in people with Chronic Hepatitis B, run by Gilead Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 2 to 17 years
Conditions the study is for: Chronic Hepatitis B
What is being tested?: Adefovir Dipivoxil (ADV) and Lamivudine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 173 participants
Where: 1 siteUnited States
Study dates: Jun 2004to Apr 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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).

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Boston, Massachusetts

Other trials in United States

About this study

Official title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Adefovir Dipivoxil in Children and Adolescents (Age 2 to Less Than 18) With Chronic Hepatitis B

Read the detailed description

Weeks 1 through 48 (Study Year 1): The first 48 weeks of the study were a randomized, double-blind, placebo-controlled, parallel-group treatment period. Participants were randomly assigned to treatment in a 2:1 fashion to ADV or PLB. Prior to randomization, eligible participants were classified into 1 of 6 strata based upon age at screening (2 to < 7 years; >= 7 to < 12 years; >= 12 to < 18 years) and prior exposure to treatment for chronic hepatitis B (CHB) (prior treatment; no prior treatment).

Weeks 49 through 240 (Study Years 2 through 5): At Week 48, all placebo-treated participants who did not exhibit HBeAg or hepatitis B surface antigen (HBsAg) seroconversion at Week 44, plus all ADV-treated participants, were offered the opportunity to receive open-label ADV for up to an additional 192 weeks. Any participant with HBV DNA >= 1000 copies/mL at 2 consecutive visits 12 weeks apart was to be discontinued from open-label study treatment. The only exception was for participants in the adolescent age range with prior lamivudine experience who were allowed the opportunity to add lamivudine to ADV; similarly, if combination failed to impart suppression of HBV DNA below 1000 copies/mL (confirmed) discontinuation was necessary. All participants who discontinued study drug due to confirmed seroconversion were requested to continue to return for study visits for the remainder of the study in order to evaluate the durability of seroconversion. Participants who wished to discontinue study treatment and withdraw from the study prior to study completion were requested to return every 4 weeks for 16 weeks for posttreatment evaluations following an early termination visit. Any participants who experienced posttreatment hepatic flares during the 16-week follow-up period were to be followed every 4 weeks until their ALT levels returned to <= 2 times the upper limit of normal (ULN) for a maximum off-treatment follow-up of 6 months. Participants who experienced a severe hepatic flare (per protocol definition) after discontinuation of ADV during the open-label treatment period may have been eligible to receive ADV for treatment of the hepatic flare (after consultation with the Gilead medical monitor).

Conditions: Chronic Hepatitis B
Being tested: Placebo (PLB), Adefovir Dipivoxil (ADV), Lamivudine
Keywords: Hepatitis B, Children, Pediatric, Adefovir Dipivoxil
Medical subject headings: Hepatitis B, Chronic, Hepatitis B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Placebo (PLB)Drug
Matching placebo
Adefovir Dipivoxil (ADV)Drug
10-mg tablet or 2-mg/mL oral suspension
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.

Study groups in NCT00095121
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Adefovir Dipivoxil (ADV); Drug: Lamivudine

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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)
The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group] and Week 48 for those originally randomized to placebo [PLB-ADV group]).
Measured: ADV baseline
Percentage of Participants With Serum HBV DNA < 1000 Copies/mL (PCR-based Assay) While on Treatment - Missing = Failure) (ADV Week 192)
Adefovir week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240), whereas participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
Measured: ADV Week 192
Percentage of Participants With Serum HBV DNA < 1000 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Week 240)
Measured: ADV Week 240
Percentage of Participants With Serum HBV DNA < 400 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Baseline)
The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group] and Week 48 for those originally randomized to placebo [PLB-ADV group]).
Measured: ADV baseline
Percentage of Participants With Serum HBV DNA < 400 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Week 192)
Adefovir week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240), whereas participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
Measured: ADV Week 192
Percentage of Participants With Serum HBV DNA < 400 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Week 240)
Measured: ADV Week 240
Adefovir (ADV) Baseline Serum HBV DNA
The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group] and Week 48 for those originally randomized to placebo [PLB-ADV group]).
Measured: ADV baseline
Change From ADV Baseline to ADV Week 192 for Serum HBV DNA
Adefovir week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240), whereas participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
Measured: ADV baseline to ADV 192 weeks
Change From ADV Baseline to ADV Week 240 for Serum HBV DNA
Measured: ADV baseline to ADV 240 weeks
ADV Baseline ALT
The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group] and Week 48 for those originally randomized to placebo [PLB-ADV group]).
Measured: ADV baseline
Change From ADV Baseline to ADV Week 192 for ALT
Adefovir week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240), whereas participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
Measured: ADV baseline to ADV 192 weeks
Change From ADV Baseline to ADV Week 240 for ALT
Measured: ADV baseline to ADV 240 weeks
Percentage of Participants With Normal ALT at Adefovir Baseline (Missing = Failure)
The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group] and Week 48 for those originally randomized to placebo [PLB-ADV group]). Normal ALT: 0-1 year old = <=54 U/L; females 1-88 years old and males 1-10 years old = 8-34 U/L; males 10-88 years old = 8-43 U/L.
Measured: ADV baseline
Percentage of Participants With Normal ALT at ADV Week 192 (Missing = Failure)
Adefovir week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240), whereas participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192). Normal ALT: 0-1 year old = <=54 U/L; females 1-88 years old and males 1-10 years old = 8-34 U/L; males 10-88 years old = 8-43 U/L.
Measured: ADV Week 192
Percentage of Participants With Normal ALT at ADV Week 240 (Missing = Failure)
Normal ALT: 0-1 year old = <=54 U/L; females 1-88 years old and males 1-10 years old = 8-34 U/L; males 10-88 years old = 8-43 U/L.
Measured: ADV Week 240
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss or Seroconversion by End of Blinded Treatment (Study Week 48; Randomized and Treated Analysis Set)
HBeAg loss is defined for an individual participant as HBeAg+ at ADV baseline and HBeAg- post baseline. HBeAg seroconversion is defined for an individual participant as HBeAg+ at ADV baseline and HBeAg- and hepatitis B e antibody + (anti-HBe+) post baseline.
Measured: Study Week 0 to Study Week 48 (double-blind period)
Percentage of Participants With HBeAg Loss or Seroconversion by ADV Week 192 (Open Label Analysis Set, Participants Who Were HBeAg Positive at ADV Baseline; Missing = Excluded)
ADV baseline = 1st ADV-dose day = Week 0 for ADV-ADV group and Week 48 for PLB-ADV group. ADV week = windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240), whereas participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192). HBeAg loss is defined per individual participant as HBeAg+ at ADV baseline and HBeAg- post baseline. HBeAg seroconversion is defined for an individual participant as HBeAg+ at ADV baseline and HBeAg- and anti-HBe+ post baseline.
Measured: ADV baseline to ADV Week 192
Percentage of Participants With HBeAg Loss or Seroconversion by ADV Week 240 (Open Label Analysis Set, Participants Who Were HBeAg Positive at ADV Baseline; Missing = Excluded)
Per protocol, participants could discontinue study medication due to HBeAg seroconversion and remain in the study in order to evaluate the durability of seroconversion. HBeAg loss is defined for an individual participant as HBeAg+ at ADV baseline and HBeAg- post baseline. HBeAg seroconversion is defined for an individual participant as HBeAg+ at ADV baseline and HBeAg- and anti-HBe+ post baseline.
Measured: ADV baseline to ADV Week 240
Cumulative Summary of Participants With HBV Genotypic Changes From Baseline (Resistance Surveillance)
Resistance surveillance was conducted annually for all participants who remained on treatment and had HBV DNA concentrations greater than or equal to the level of detection (>= 169 copies/mL) by PCR. The last on-ADV sample for all participants in the study was analyzed in the cumulative Week 240 resistance surveillance analysis.
Measured: 240 weeks
Cumulative Summary of Participants With HBV Genotypic Changes From Baseline (Resistance Surveillance) for Subjects Who Received Combination ADV + Lamivudine Therapy
Resistance surveillance was conducted at Week 240/last on-treatment study visit for all participants who had HBV DNA concentrations greater than or equal to the level of detection (>= 169 copies/mL) by PCR while on combination ADV + lamivudine treatment.
Measured: 240 weeks
Percentage of Participants With Durable HBeAg Seroconversion
A participant was defined to have durable HBeAg seroconversion only if she/he remained in a seroconverted state (HBeAg-, hepatitis B e antibody + [anti-HBe+]) from the date that she/he first seroconverted through and including her/his last study visit. This endpoint could only be assessed for participants who (HBeAg-) seroconverted on-treatment and subsequently discontinued open-label dosing.
Measured: 240 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2004Apr 2010

First posted1 Nov 2004 (estimated)
Study startJun 2004
Primary completionMay 2006
Study completionApr 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
More trials run by Gilead SciencesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 173 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00095121
Sponsor's protocol ID: GS-US-103-0518
Status last verified: May 2012
First submitted: 29 Oct 2004
Last updated: 22 May 2012
Results posted: Yes, on ClinicalTrials.gov

Publications

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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
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All Chronic Hepatitis B trials

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Adefovir Dipivoxil in Children and Adolescents (Age 2 to Less Than 18) With Chronic Hepatitis B
ClinicalTrials.gov ID: NCT00095121
Acronym / sponsor ID: GS-US-103-0518
Conditions: Chronic Hepatitis B
Keywords: Hepatitis B, Children, Pediatric, Adefovir Dipivoxil
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 173 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: Jun 2004
Primary completion: May 2006 (actual)
Study completion: Apr 2010 (actual)
First posted: 1 Nov 2004 (estimated)
Results: Posted 3 Jun 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo (PLB)	Placebo comparator	Drug: Placebo (PLB), Drug: LamivudineParticipants 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.
Adefovir Dipivoxil (ADV)	Experimental	Drug: Adefovir Dipivoxil (ADV), Drug: LamivudineParticipants 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.

Who may qualify

Ages: 2 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

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).

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Placebo (PLB)Matching placebo	Drug	Placebo (PLB)
Adefovir Dipivoxil (ADV)10-mg tablet or 2-mg/mL oral suspension	Drug	Adefovir Dipivoxil (ADV)
Lamivudine100-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.	Drug	Adefovir Dipivoxil (ADV), Placebo (PLB)

Primary outcome

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)
Time frame: Week 48
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.

21 secondary outcomes

Percentage of Participants With Serum HBV DNA < 1000 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Baseline)
Time frame: ADV baseline
Percentage of Participants With Serum HBV DNA < 1000 Copies/mL (PCR-based Assay) While on Treatment - Missing = Failure) (ADV Week 192)
Time frame: ADV Week 192
Percentage of Participants With Serum HBV DNA < 1000 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Week 240)
Time frame: ADV Week 240
Percentage of Participants With Serum HBV DNA < 400 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Baseline)
Time frame: ADV baseline
Percentage of Participants With Serum HBV DNA < 400 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Week 192)
Time frame: ADV Week 192
Percentage of Participants With Serum HBV DNA < 400 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Week 240)
Time frame: ADV Week 240
Adefovir (ADV) Baseline Serum HBV DNA
Time frame: ADV baseline
Change From ADV Baseline to ADV Week 192 for Serum HBV DNA
Time frame: ADV baseline to ADV 192 weeks
Change From ADV Baseline to ADV Week 240 for Serum HBV DNA
Time frame: ADV baseline to ADV 240 weeks
ADV Baseline ALT
Time frame: ADV baseline
Change From ADV Baseline to ADV Week 192 for ALT
Time frame: ADV baseline to ADV 192 weeks
Change From ADV Baseline to ADV Week 240 for ALT
Time frame: ADV baseline to ADV 240 weeks
Percentage of Participants With Normal ALT at Adefovir Baseline (Missing = Failure)
Time frame: ADV baseline
Percentage of Participants With Normal ALT at ADV Week 192 (Missing = Failure)
Time frame: ADV Week 192
Percentage of Participants With Normal ALT at ADV Week 240 (Missing = Failure)
Time frame: ADV Week 240
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss or Seroconversion by End of Blinded Treatment (Study Week 48; Randomized and Treated Analysis Set)
Time frame: Study Week 0 to Study Week 48 (double-blind period)
Percentage of Participants With HBeAg Loss or Seroconversion by ADV Week 192 (Open Label Analysis Set, Participants Who Were HBeAg Positive at ADV Baseline; Missing = Excluded)
Time frame: ADV baseline to ADV Week 192
Percentage of Participants With HBeAg Loss or Seroconversion by ADV Week 240 (Open Label Analysis Set, Participants Who Were HBeAg Positive at ADV Baseline; Missing = Excluded)
Time frame: ADV baseline to ADV Week 240
Cumulative Summary of Participants With HBV Genotypic Changes From Baseline (Resistance Surveillance)
Time frame: 240 weeks
Cumulative Summary of Participants With HBV Genotypic Changes From Baseline (Resistance Surveillance) for Subjects Who Received Combination ADV + Lamivudine Therapy
Time frame: 240 weeks
Percentage of Participants With Durable HBeAg Seroconversion
Time frame: 240 weeks

Results and safety

Results posted to the registry on 3 Jun 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ADV - ADV	115	112
PLB - ADV	58	58

Primary outcome: 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)

Time frame: Week 48. Number. Unit: percentage of participants

Measure	Adefovir Dipivoxil (ADV) n = 115	Placebo (PLB) n = 58
Baseline	0	0
Week 24	5	0
Week 48 or End of Double-blind Treatment	19	2

Adefovir Dipivoxil (ADV) vs Placebo (PLB): p <0.001, Fisher Exact

Population analysed: All randomized participants who received \>= 1 dose study medication. If either endpoint was missing a Week 48 value, Week 44 value was substituted and used in the combined endpoint. If participant did not have serum HBV DNA value at Weeks 44 and 48 or ALT value at Weeks 44 and 48, then participant was considered a failure for the Week-48 analysis.

21 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected over the entire 240-week duration of the study (ie, during the 48 weeks of randomized treatment and subsequent 192 weeks of open-label treatment).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ADV (Double-Blind)	7 of 115 (6.1%)	95 of 115 (82.6%)	Not reported
PLB (Double-Blind)	5 of 58 (8.6%)	47 of 58 (81%)	Not reported
ADV - ADV	10 of 108 (9.3%)	73 of 108 (67.6%)	Not reported
PLB - ADV	3 of 54 (5.6%)	46 of 54 (85.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundSokal, 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.
Related InfoLink provided by the sponsor.
Study ResultsLink provided by the sponsor.

Related trials for Chronic Hepatitis B

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John Flaherty, PharmD study director

Gilead Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Adefovir Dipivoxil (ADV) and Lamivudine in people with Chronic Hepatitis B, run by Gilead Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00095121, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2012.