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Chronic Hepatitis BPhase 2NCT01037062

An Open-Label Rollover Study of Entecavir (BMS-200475) in Adults With Chronic Hepatitis B Infection

A Phase 2 study testing Entecavir in people with Chronic Hepatitis B, run by Bristol-Myers Squibb at 48 sites in Japan.

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

To provide open-label entecavir to subjects who have completed previous blinded entecavir trials in Japan and are assessed by the investigator as likely to benefit from additional anti-hepatitis B therapy Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Chronic Hepatitis B
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
282 participants
Where
48 sitesJapan
Study dates
Dec 2003to Dec 2006
Phase
Phase 2
Are there results?
None posted in the registry

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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects who completed a previous entecavir Phase II studies (AI463047, 052 or 053);
  • ALT ≤ 10 x upper limit of normal;
  • Subjects must have well-compensated liver disease according to ALL of the following criteria;
  • Prothrombin time ≤ 3 seconds prolonged compared to control value or INR ≤ 1.5
  • Serum albumin ≥ 3 g/dL (≥ 30 g/L)
  • Serum bilirubin ≤ 2.5 mg/dL (≤ 42.75 μmol/L)

Who cannot join

  • Sex and Reproductive Status Exceptions
  • Target Disease Exceptions
  • Medical History and Concurrent Diseases

Trial locations and contacts

48 sites in 1 country.

48 sites in 1 country

Japan48 sites

  • Local Institution

    Aichi-Gun, Aichi-ken, 480-1195

  • Local Institution

    Akashi-Shi, Hyōgo, 673-0848

  • Local Institution

    Asahikawa-Shi, Hokkaido, 070-0054

  • Local Institution

    Chiba, Chiba

  • Local Institution

    Fukuoka, Fukuoka, 814-0180

  • Local Institution

    Fukuyama-Shi, Hiroshima, 721-0971

  • Local Institution

    Gifu, Gifu, 500-8513

  • Local Institution

    Hiroshima, Hiroshima, 730-8518

  • Local Institution

    Hiroshima, Hiroshima, 734-0037

  • Local Institution

    Iruma-Gun, Saitama, 350-0495

  • Local Institution

    Kawachinagano-Shi, Osaka, 86-0008

  • Local Institution

    Kumamoto, Kumamoto, 860-8556

  • Local Institution

    Kurashiki-Shi, Okayama-ken, 710-8602

  • Local Institution

    Kurume, Fukuoka

  • Local Institution

    Kyoto, Kyoto

  • Local Institution

    Matsumoto, Nagano, 390-0802

  • Local Institution

    Minato-Ku, Tokyo, 105-0001

  • Local Institution

    Mitoyo-Gun, Kagawa-ken, 769-1601

  • Local Institution

    Miyazaki-Gun, Miyazaki, 889-1692

  • Local Institution

    Morioka, Iwate, 020-8505

  • Local Institution

    Musashino-Shi, Tokyo, 180-0023

  • Local Institution

    Nagasaki, Nagasaki

  • Local Institution

    Nagoya, Aichi-ken, 457-0866

  • Local Institution

    Nagoya, Aichi-ken, 466-8550

  • Local Institution

    Nagoya, Aichi-ken, 467-8602

  • Local Institution

    Nakakoma-Gun, Yamanashi, 409-3821

  • Local Institution

    Niigata, Niigata

  • Local Institution

    Ogaki-Shi, Gifu, 503-8502

  • Local Institution

    Oita-Gun, Oita Prefecture, 879-5503

  • Local Institution

    Okayama, Okayama-ken, 700-0082

  • Local Institution

    Okayama, Okayama-ken, 700-8505

  • Local Institution

    Okayama, Okayama-ken, 700-8511

  • Local Institution

    Omura-Shi, Nagasaki, 856-0000

  • Local Institution

    Onsen-Gun, Ehime, 791-0204

  • Local Institution

    Osaka, Osaka, 553-0003

  • Local Institution

    Osaka, Osaka

  • Local Institution

    Sakai-Shi, Osaka, 591-8025

  • Local Institution

    Sapporo, Hokkaido, 006-0813

  • Local Institution

    Sapporo, Hokkaido, 060-0033

  • Local Institution

    Sendai, Miyagi

  • Local Institution

    Shinjuku-Ku, Tokyo, 160-8582

  • Local Institution

    Shinjuku-Ku, Tokyo, 162-8655

  • Local Institution

    Shinjuku-Ku, Tokyo, 162-8666

  • Local Institution

    Suita-Shi, Osaka

  • Local Institution

    Takamatsu, Kagawa-ken

  • Local Institution

    Tokyo, Tokyo, 173-8610

  • Local Institution

    Tsuyama-Shi, Okayama-ken, 708-0841

  • Local Institution

    Ube-Shi, Yamaguchi, 755-0067

Other trials in Japan

About this study

Official title: An Open-Label Rollover Study of Entecavir (BMS-200475) in Adults With Chronic Hepatitis B Infection Who Have Completed Previous Phase II Studies in Japan But Who Require Further Treatment

To provide open-label entecavir to subjects who have completed previous blinded entecavir trials in Japan and are assessed by the investigator as likely to benefit from additional anti-hepatitis B therapy

Being tested
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

    Tablet, P.O. 0.5, 1 mg, once daily

Study groups in NCT01037062
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. To provide open-label entecavir to subjects who have completed previous blinded entecavir trials in Japan and are assessed by the investigator as likely to benefit from additional anti-hepatitis B therapy

    Measured: 24 weeks

Secondary outcomes (12)

  1. Incidence of clinical adverse events and discontinuations due to adverse events of entecavir for each cohort

    Measured: Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 post dosing

  2. Incidence of laboratory abnormalities of of entecavir for each cohort

    Measured: Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 post dosing

  3. Proportion of subjects HBeAg-positive at baseline who have loss of HBeAg from serum

    Measured: Day 1, Week 12, Week 24 and every subsequent 24 week during dosing

  4. Proportion of subjects HBeAg-positive at baseline who achieve seroconversion (loss of HBeAg and appearance of HBeAb)

    Measured: Day 1, Week 12, Week 24 and every subsequent 24 week during dosing

  5. Proportion of subjects with abnormal ALT at baseline who achieve normalization of serum ALT at Week 48

    Measured: Day 1, Week 48

  6. Proportion of subjects who achieve HBV DNA levels by PCR assay less than the limit of quantification (LOQ)

    Measured: Day 1, Week 12, 24, and subsequent 24 week during dosing

  7. Proportion of subjects positive for HBeAg at baseline who achieve HBV DNA levels by PCR assay less than LOQ, normal serum ALT, and seroconversion

    Measured: Week 8, 16, 24 post dosing

  8. Proportion of subjects negative for HBeAg at baseline who achieve HBV DNA levels by PCR assay less than LOQ and normal ALT and remain negative for HBeAg

    Measured: Day 1, Week 12, Week 24 and every subsequent 24 weeks during dosing

  9. Proportion of subjects who achieved Complete Response during therapy, who have sustained Complete Response for 24 weeks after stopping drug

    Measured: 24 Week post dosing

  10. Proportion of subjects with histological improvement in the liver at Wks 48 & 96 [improvement in necroinflammatory score and no worsening of fibrosis at Wks 48 & 96 liver biopsy compared to baseline & to baseline in previous study]

    Measured: Week 48, 96

  11. NChanges in liver histology as assessed by the New Inuyama Classification for histological assessment of chronic hepatitis

    Measured: Week 48 & Week 96

  12. Incidence of genotypic changes in HBV DNA polymerase conferring resistance to entecavir in subjects with confirmed ≥1 log10 increase in HBV DNA from nadir on treatment

    Measured: Week 2, 4, ± days, Week 8 every 4 weeks ± 7 days

Timeline

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

  1. First posted21 Dec 2009 (estimated)
  2. Study startDec 2003
  3. Primary completionDec 2006
  4. Study completionDec 2006

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 2
Primary purpose
Treatment
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
282 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01037062
Sponsor's protocol ID
AI463-060
Status last verified
Dec 2009
First submitted
17 Dec 2009
Last updated
31 Jan 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Yokosuka O, Takaguchi K, Fujioka S, Shindo M, Chayama K, Kobashi H, Hayashi N, Sato C, Kiyosawa K, Tanikawa K, Ishikawa H, Masaki N, Seriu T, Omata M. Long-term use of entecavir in nucleoside-naive Japanese patients with chronic hepatitis B infection. J Hepatol. 2010 Jun;52(6):791-9. doi: 10.1016/j.jhep.2009.12.036. Epub 2010 Mar 24.

    PubMed 20409606

  • Karino Y, Toyota J, Kumada H, Katano Y, Izumi N, Kobashi H, Sata M, Moriyama M, Imazeki F, Kage M, Ishikawa H, Masaki N, Seriu T, Omata M. Efficacy and resistance of entecavir following 3 years of treatment of Japanese patients with lamivudine-refractory chronic hepatitis B. Hepatol Int. 2010 Feb 6;4(1):414-22. doi: 10.1007/s12072-009-9162-x.

    PubMed 20305760

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Entecavir in people with Chronic Hepatitis B, run by Bristol-Myers Squibb at 48 sites in Japan.

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 6 inclusion and 3 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 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in Japan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To provide open-label entecavir to subjects who have completed previous blinded entecavir trials in Japan and are assessed by the investigator as likely to benefit from additional anti-hepatitis B therapy (time frame: 24 weeks). 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 NCT01037062, which also lists 2 linked publications.

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 Jan 2011.

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