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Hepatitis B, ChronicPhase 4NCT00718887

Suboptimal Responders to Adefovir Switching to Entecavir

A Phase 4 study testing Entecavir and Adefovir/Entecavir in people with Hepatitis B, Chronic, run by Bristol-Myers Squibb at 8 sites in China.

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

Switching to Entecavir will result in superior antiviral efficacy as compared to continuing with Adefovir in patients with a suboptimal response to Adefovir 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 and Adefovir/Entecavir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
228 participants
Where
8 sitesChina
Study dates
Jul 2008to Jan 2011
Phase
Phase 4
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

  • Chronic infection with hepatitis B virus (HBV)(detectable hepatitis B surface antibody (HBsAg) at screening and at least 24 weeks prior to screening, or detectable HBsAg for <24 weeks and negative for immunoglobulin M core antibody)
  • Documentation of hepatitis B e antigen (HBeAg) positive or negative status
  • Naive to nucleoside/nucleotide analogues, with the exception of adefovir
  • Suboptimal response to adefovir treatment
  • No lamivudine/telbivudine, entecavir, or adefovir resistance-associated substitutions at screening
  • Male or female gender, aged 16 years and older
  • Compensated liver function
  • Serum alanine aminotransferase level <10*upper limit of normal at screening

Who cannot join

  • Women who are pregnant or breastfeeding
  • Evidence of decompensated cirrhosis
  • Coinfection with HIV, hepatitis C virus, or hepatitis D virus
  • Recent history of pancreatitis (within 24 weeks prior to the first dose of study medication)
  • Chronic renal insufficiency, defined as a creatinine clearance <50 mL/min
  • Current abuse of illegal drugs or alcohol, sufficient in the investigator's opinion to prevent adequate compliance with study therapy or to increase the risk of hepatotoxicity or pancreatitis
Show all 11Show fewer
  • Other serious medical conditions that might preclude completion of this study or that require chronic administration of prohibited medications
  • Serum creatinine level >1.5 mg/dL; hemoglobin level <10.0 g/dL; platelet count <70,000/mm^3; absolute neutrophil count <1500 cells/mm^3; serum alpha fetoprotein level >100 ng/mL
  • Except adefovir, any prior therapy with nucleoside or nucleotide analogue antiviral agents with activity against hepatitis B (eg, lamivudine, entecavir), or any other experimental anti-HBV antiviral, or any China Traditional Medicine
  • Therapy with interferon, thymosin alpha, or other immunostimulators within 24 weeks of randomization
  • Required chronic administration of medications that cause immunosuppression, that are associated with a high risk of nephrotoxicity or hepatotoxicity, or that affect renal excretion.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

China8 sites

  • Local Institution

    Beijing, Beijing Municipality, 100011

  • Local Institution

    Changchun, Jilin, 130021

  • Local Institution

    Guiyang, Guizhou, 550004

  • Local Institution

    Nanchang, Jiangxi, 330006

  • Local Institution

    Nanjing, Jiangsu, 210002

  • Local Institution

    Shanghai, Shanghai Municipality, 200235

  • Local Institution

    Shanghai, Shanghai Municipality

  • Local Institution

    Shenyang, Liaoning, 110004

Other trials in China

About this study

Official title: A Comparative Study of the Week 12 Antiviral Efficacy and Safety of Switching to Entecavir vs. Continuing Adefovir Treatment in Adults With Chronic Hepatitis B and Suboptimal Response to Adefovir

Switching to Entecavir will result in superior antiviral efficacy as compared to continuing with Adefovir in patients with a suboptimal response to Adefovir

Being tested
Entecavir, Adefovir/Entecavir
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, 0.5 mg, once daily (QD), 52 weeks

  • Adefovir/EntecavirDrug

    Also called Baraclude, BMS-200475

    Tablets, Oral, 10-mg adefovir QD for 12 weeks followed by 0.5-mg entecavir QD for a maximum of 52 weeks

Study groups in NCT00718887
Study groupRoleWhat they receive
Entecavir, 0.5 mg QDExperimentalNot described
Receives: Drug: Entecavir
Adefovir, 10 mg QD/Entecavir, 0.5 mg QDOtherControl
Receives: Drug: Adefovir/Entecavir

What is being measured

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

  1. Percentage of Participants Who Achieved a Hepatitis B Virus (HBV) DNA Level <50 IU/mL at Week 12 by Polymerase Chain Reaction Testing

    HBV DNA Level <50 IU/mL=approximately 300 copies/mL.

    Measured: At Week 12 from Day 1

Secondary outcomes (8)

  1. Percentage of Participants Who Achieved an HBV DNA Level <50 IU/mL at Week 48 by Polymerase Chain Reaction Testing

    HBV=hepatitis B virus. HBV DNA Level <50 IU/mL=approximately 300 copies/mL.

    Measured: At Week 48 from Day 1

  2. Mean log10 Reduction From Baseline in Serum HBV DNA Level by Polymerase Chain Reaction Testing

    HBV=hepatitis B virus

    Measured: At Weeks 12 and 48 from Day 1

  3. Percentage of Participants Who Achieved Normalization of Alanine Aminotransferase (ALT)

    ULN=upper limit of normal. ALT normalization= ≤1*ULN, among participants with baseline ALT >1*ULN

    Measured: At Weeks 12 and 48 from Day 1

  4. Percentage of Participants With Loss of Hepatitis B e Antigen (HBeAg) and Hepatitis B e (HBe) Seroconversion

    Measured: At Weeks 12 and 48 from Day 1

  5. Number of Participants With Hepatitis B s Surface Antibody (HBsAG) Loss and HBsAG Seroconversion

    Measured: At Weeks 12 and 48 from Day 1

  6. Number of Participants With Genotypic Resistance to Entecavir

    Measured: At Week 48 from Day 1

  7. Number of Participants With Adverse Events, Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs, Death as Outcome, Discontinuations Due to AEs, and Abnormalities in Laboratory Test Results (LTR) Leading to Discontinuation

    AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study drug.

    Measured: Continually from Day 1 through Week 48, and through 24-week follow-up period

  8. Percentage of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results

    Hematology testing assessed levels of hemoglobin, white blood cells, platelets, neutrophils, international normalized ration, red blood cells, lymphocytes, and monocytes.

    Measured: Day 1 through Week 48

Timeline

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

  1. First posted21 Jul 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionDec 2009
  4. Study completionJan 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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
228 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00718887
Sponsor's protocol ID
AI463-171
Status last verified
Jan 2013
First submitted
17 Jul 2008
Last updated
11 Feb 2013
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Entecavir and Adefovir/Entecavir in people with Hepatitis B, Chronic, run by Bristol-Myers Squibb at 8 sites in China.

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 8 inclusion and 11 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 11 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 11 Feb 2013). 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 Who Achieved a Hepatitis B Virus (HBV) DNA Level <50 IU/mL at Week 12 by Polymerase Chain Reaction Testing (time frame: At Week 12 from Day 1). 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 NCT00718887.

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 11 Feb 2013.

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