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

NCT01037062 | Completed Phase 2 DMC

• 1 other identifier: AI463-060
• Study Type: interventional
• Target: 282
• Locations: 1 country
• Sites: 48

Brief 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

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (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

  24 weeks

Secondary Outcomes (12)

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

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

• Incidence of laboratory abnormalities of of entecavir for each cohort

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

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

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

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

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

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

  Day 1, Week 48

Study Arms (1)

Entecavir

EXPERIMENTAL

Drug: Entecavir

Interventions

Entecavir DRUG

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

Also known as: Baraclude, BMS-200475

Entecavir

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (48)

Local Institution

Aichi-Gun, Aichi-ken, 480-1195, Japan

Location

Local Institution

Nagoya, Aichi-ken, 457-0866, Japan

Location

Local Institution

Nagoya, Aichi-ken, 466-8550, Japan

Location

Local Institution

Nagoya, Aichi-ken, 467-8602, Japan

Location

Local Institution

Chiba, Chiba, Japan

Location

Local Institution

Onsen-Gun, Ehime, 791-0204, Japan

Location

Local Institution

Fukuoka, Fukuoka, 814-0180, Japan

Location

Local Institution

Kurume, Fukuoka, Japan

Location

Local Institution

Gifu, Gifu, 500-8513, Japan

Location

Local Institution

Ogaki-Shi, Gifu, 503-8502, Japan

Location

Local Institution

Fukuyama-Shi, Hiroshima, 721-0971, Japan

Location

Local Institution

Hiroshima, Hiroshima, 730-8518, Japan

Location

Local Institution

Hiroshima, Hiroshima, 734-0037, Japan

Location

Local Institution

Asahikawa-Shi, Hokkaido, 070-0054, Japan

Location

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Sapporo, Hokkaido, 006-0813, Japan

Location

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Sapporo, Hokkaido, 060-0033, Japan

Location

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Akashi-Shi, Hyōgo, 673-0848, Japan

Location

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Morioka, Iwate, 020-8505, Japan

Location

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Mitoyo-Gun, Kagawa-ken, 769-1601, Japan

Location

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Takamatsu, Kagawa-ken, Japan

Location

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Kumamoto, Kumamoto, 860-8556, Japan

Location

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Kyoto, Kyoto, Japan

Location

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Sendai, Miyagi, Japan

Location

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Miyazaki-Gun, Miyazaki, 889-1692, Japan

Location

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Matsumoto, Nagano, 390-0802, Japan

Location

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Nagasaki, Nagasaki, Japan

Location

Local Institution

Omura-Shi, Nagasaki, 856-0000, Japan

Location

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Niigata, Niigata, Japan

Location

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Oita-Gun, Oita Prefecture, 879-5503, Japan

Location

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Kurashiki-Shi, Okayama-ken, 710-8602, Japan

Location

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Okayama, Okayama-ken, 700-0082, Japan

Location

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Okayama, Okayama-ken, 700-8505, Japan

Location

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Okayama, Okayama-ken, 700-8511, Japan

Location

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Tsuyama-Shi, Okayama-ken, 708-0841, Japan

Location

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Kawachinagano-Shi, Osaka, 86-0008, Japan

Location

Local Institution

Osaka, Osaka, 553-0003, Japan

Location

Local Institution

Osaka, Osaka, Japan

Location

Local Institution

Sakai-Shi, Osaka, 591-8025, Japan

Location

Local Institution

Suita-Shi, Osaka, Japan

Location

Local Institution

Iruma-Gun, Saitama, 350-0495, Japan

Location

Local Institution

Minato-Ku, Tokyo, 105-0001, Japan

Location

Local Institution

Musashino-Shi, Tokyo, 180-0023, Japan

Location

Local Institution

Shinjuku-Ku, Tokyo, 160-8582, Japan

Location

Local Institution

Shinjuku-Ku, Tokyo, 162-8655, Japan

Location

Local Institution

Shinjuku-Ku, Tokyo, 162-8666, Japan

Location

Local Institution

Tokyo, Tokyo, 173-8610, Japan

Location

Local Institution

Ube-Shi, Yamaguchi, 755-0067, Japan

Location

Local Institution

Nakakoma-Gun, Yamanashi, 409-3821, Japan

Location

Related Publications (2)

• 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.

  PMID: 20409606 BACKGROUND

• 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.

  PMID: 20305760 BACKGROUND

Related Links

• Investigator Inquiry form

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

entecavir

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 17, 2009
• First Posted: December 21, 2009
• Study Start: December 1, 2003
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: January 31, 2011

Record last verified: 2009-12

Locations

JP (48)