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Hepatitis B, ChronicPhase 3NCT00395018

Antiviral Activity of Entecavir in Patients Receiving Liver Transplant Due to Chronic Hepatitis B Virus Infection

A Phase 3 study testing entecavir in people with Hepatitis B, Chronic, run by Bristol-Myers Squibb at 32 sites in 9 countries.

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 clinical research study is to learn if the study drug entecavir will prevent the recurrence of hepatitis B virus (HBV) in participants who receive an orthotopic liver transplant (OLT) due to HBV infection. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Hepatitis B, Chronic
What is being tested?
entecavir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
109 participants
Where
32 sitesin 9 countries
Study dates
Apr 2007to Mar 2011
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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients receiving orthotopic liver transplant (OLT) due to end-stage liver disease because of chronic HBV infection, with HBV-DNA < 172 IU/mL (approximately < 1000 copies/mL) prior to liver transplant
  • Must have detectable hepatitis B surface antigen (HBsAg) at screening and for at least 24 weeks prior to screening

Who cannot join

  • Patients with hepatocellular carcinoma with evidence of extrahepatic spread, multiple tumors ≥ 6.5 cm in diameter or there is up to three nodules ≥ 4.5 cm in diameter and total tumor diameter is ≥ 8 cm
  • Co-infection with human immunodeficiency virus (HIV), cytomegalovirus (CMV), Epstein-Barr virus (EBV) or hepatitis C virus (HCV)

Trial locations and contacts

32 sites in 9 countries.

32 sites in 9 countries

United States9 sites

  • Northwestern University

    Chicago, Illinois, 60611

  • University Of Cincinnati Medical Center

    Cincinnati, Ohio, 45267

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • Baylor College Of Medicine

    Houston, Texas, 77030

  • Tulane University Hospital & Clinic

    New Orleans, Louisiana, 70112

  • University Of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University Of Rochester Medical Center

    Rochester, New York, 14642

Other trials in United States

Italy4 sites

  • Local Institution

    Bologna, 40125

  • Local Institution

    Roma, 00133

  • Local Institution

    Roma, 00168

  • Local Institution

    Torrette Di Ancona, 60020

Other trials in Italy

South Korea4 sites

  • Local Institution

    Seoul, 110-744

  • Local Institution

    Seoul, 120-752

  • Local Institution

    Seoul, 135-710

  • Local Institution

    Seoul, 138-736

Other trials in South Korea

Spain4 sites

  • Local Institution

    Barcelona, 08035

  • Local Institution

    Barcelona, 08036

  • Local Institution

    Madrid, 280009

  • Local Institution

    Valencia, 46009

Other trials in Spain

Brazil3 sites

  • Local Institution

    Fortaleza, Ceará, 60430

  • Local Institution

    Porto Alegre, Rio Grande do Sul, 90035

  • Local Institution

    São Paulo, São Paulo, 01246

Other trials in Brazil

France3 sites

  • Local Institution

    Clichy, 92118

  • Local Institution

    Paris, 75571

  • Local Institution

    Villejuif, 94800

Other trials in France

Australia2 sites

  • Local Institution

    Heidelberg, Victoria, 3084

  • Local Institution

    Woolloongabba, Queensland, 4102

Other trials in Australia

Taiwan2 sites

  • Local Institution

    Kaohsiung City, 833

  • Local Institution

    Taipei, 112

Other trials in Taiwan

Argentina1 site

  • Local Institution

    Buenos Aires, Buenos Aires, C1181ACH

Other trials in Argentina

About this study

Official title: Study of the Antiviral Activity of Entecavir in Patients Receiving Liver Transplant Due to Chronic Hepatitis B Virus Infection

The purpose of this clinical research study is to learn if the study drug entecavir will prevent the recurrence of hepatitis B virus (HBV) in participants who receive an orthotopic liver transplant (OLT) due to HBV infection.

Being tested
entecavir
Keywords
Chronic Hepatitis B Virus, Liver Transplant
Medical subject headings
Hepatitis B, Chronic

What participants receive

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

  • entecavirDrug

    Also called Baraclude, BMS-200475

    Tablets, Oral, 1 mg, once daily, up to 72 weeks

Study groups in NCT00395018
Study groupRoleWhat they receive
entecavirExperimentalNot described
Receives: Drug: entecavir

What is being measured

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

  1. Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) => 50 IU/mL by Polymerase Chain Reaction (PCR) at Week 72

    HBV DNA assessments were performed using the Roche COBAS® TaqMan High+Pure system (HPS) assay. HBV DNA => 50 IU/mL = approximately => 300 copies/mL.

    Measured: At 72 weeks

  2. Number of Participants With HBV DNA by PCR >= 50 IU/mL Through Week 72

    HBV DNA assessments were performed using the Roche COBAS® TaqMan High+Pure system (HPS) assay. HBV DNA => 50 IU/mL = approximately => 300 copies/mL.

    Measured: At baseline (day 1), week 12, 24, 36, 48, 60, and 72

Secondary outcomes (14)

  1. Distribution of ALT Levels Through 72 Weeks: Overall

    ALT is an enzyme present in serum and various tissues of the body, associated commonly with the liver. Elevated levels of ALT often suggests existence of medical problems which includes viral hepatitis. Normal range varies from laboratory to laboratory. Values of 5-60 U/L is usually considered normal. ALT abnormality = >1.25 x ULN (upper limit of normal).

    Measured: On Day 1 (baseline) and at week 4, 12, 24, 36, 48, 60, 72

  2. Percentage of Participants With HBV DNA < 50 IU/mL (Approximately 300 Copies/mL) by PCR at the End of Post-dosing Follow-up

    HBV DNA assessments were to be performed using the Roche COBAS® TaqMan AmpliPrep assay. HBV DNA < 50 IU/mL = approximately 300 copies/mL.

    Measured: At 72 weeks + 24 weeks follow-up

  3. Percentage of Participants With HBeAg Loss at Week 72 (for HBeAg-positive Participants)

    HBeAg is a hepatitis B viral protein. HBeAg loss = HBeAg-negative at the specified analysis week.

    Measured: At week 72

  4. Percentage of Participants With HBeAg Seroconversion at Week 72 (for HBeAg-positive Participants)

    HBeAg is a hepatitis B viral protein. HBeAg Seroconversion = HBeAg Loss and Presence of Hepatitis B e Antibody (HBeAb).

    Measured: At week 72

  5. Percentage of Participants With HBsAg Loss at Week 72

    HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBsAg loss = HBsAg-negative at the specified analysis week.

    Measured: At week 72

  6. Percentage of Participants With HBsAg Seroconversion at Week 72

    HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBs seroconversion is defined as HBsAg loss with positive HBsAb.

    Measured: At week 72

  7. Percentage of Participants With HBsAg Recurrence At Week 72

    HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBsAg recurrence is defined as having detectable HBsAg among participants who have already experienced loss of HBsAg on-treatment. HBsAg recurrence = HBsAg-positive at the specified analysis week.

    Measured: At week 72

  8. Total Bilirubin at Week 72

    Bilirubin measures are used to diagnose or monitor liver functioning or diseases that include hepatitis. Viral hepatitis is one of the condition in which bilirubin levels are elevated. Normal range varies from laboratory to laboratory. Bilirubin abnormality : => 1.1 x ULN mg/dL.

    Measured: At week 72

  9. Prothrombin Time (PT) at Week 72

    Prothrombin, a liver protein, plays an important role in the extrinsic pathway of clotting. Increased prothrombin time indicates abnormal liver functioning. Normal prothrombin time varies from laboratory to laboratory. Generally, normal prothrombin time varies between 10 to 13.2 seconds. Abnormal PT: > 1.01 x ULN.

    Measured: At week 72

  10. Number of Participants With Liver Rejection Through Week 72

    Measured: Through week 72

  11. Number of Participants With Re-transplantation Through Week 72

    Measured: Through week 72

  12. Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to AEs (On-treatment [OT] and Off-treatment Follow-up [OF])

    AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or an overdose. Toxicity grading by modified WHO grade system. Grade (GR) 2=moderate; GR3=severe; GR4=very severe. OT=from start of dosing to end of dosing+5 days; OF=from end of dosing+6 days to start of other anti-HBV therapy or end of follow-up.

    Measured: OT:From start of dosing through Week 72 + 5 days; OF:End of OT through 24-weeks follow-up

  13. Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment Follow-up(OF): Hematology (All Grades)

    Criteria for hematology abnormalities were: Hemoglobin : <11.0 g/dL; White Blood Cells : <4000/mm^3; Neutrophils : <1500/mm^3; Platelets : < 99,000/mm^3; International Normalized Ratio (INR) : increase >= 0.5 from baseline.

    Measured: OT:From start of dosing through Week 72 + 5 days; OF:End of OT through 24-weeks follow-up

  14. Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades)

    Normal ranges are local lab data and vary according to the site. Criteria for laboratory abnormalities:ALT:>1.25xULN;AST:>1.25xULN;ALP:>1.25xULN;Total Bilirubin:>1.1xULN;Serum Lipase:>1.10xULN;Creatinine:>1.1xULN;Blood Urea Nitrogen:>1.25xULN;Hyperglycemia:>116mg/dL;Hypoglycemia:<64mg/dL;Hyponatremia:<132meq/L;Hypernatremia:>148meq/L;Hypokalemia:<3.4meq/L;hyperkalemia:>5.6meq/L;Hypochloremia:<93meq/L;Hyperchloremia:>113meq/L;Albumin: Decrease >= 1g/dL from baseline and < 3 g/dL. HYPER=value>ULN(upper limit of normal). HYPO=value<LLN (lower limit of normal).

    Measured: OT:From start of dosing through Week 72 + 5 days; OF:End of OT through 24-weeks follow-up

Timeline

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

  1. First posted2 Nov 2006 (estimated)
  2. Study startApr 2007
  3. Primary completionMar 2011
  4. Study completionMar 2011

Resources

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
Prevention
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
109 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00395018
Sponsor's protocol ID
AI463-109
Status last verified
Apr 2012
First submitted
1 Nov 2006
Last updated
31 May 2012
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing entecavir in people with Hepatitis B, Chronic, run by Bristol-Myers Squibb at 32 sites in 9 countries.

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 2 inclusion and 2 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 31 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 32 sites in United States, Italy, South Korea, Spain, Brazil and 4 more countries. 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. 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 31 May 2012). 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 HBV Deoxyribonucleic Acid (DNA) => 50 IU/mL by Polymerase Chain Reaction (PCR) at Week 72 (time frame: At 72 weeks). The study lists 2 primary outcomes in all. 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 NCT00395018.

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 31 May 2012.

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