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| Sponsor: | Bristol-Myers Squibb |
|---|---|
| Information provided by: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00410202 |
Purpose
The purpose of this study is to evaluate the effectiveness of entecavir plus adefovir combination therapy versus entecavir monotherapy or therapy with adefovir plus lamivudine
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis B, Chronic |
Drug: Entecavir Drug: Tenofovir Drug: Adefovir Drug: Lamivudine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Comparative Study of Entecavir vs. Adefovir Plus Lamivudine vs Combination Entecavir Plus Adefovir in Lamivudine-resistant Chronic Hepatitis B Subjects: The DEFINE Study |
| Estimated Enrollment: | 420 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Entecavir: Active Comparator
With the option of adding Tenofovir at week 48. (This does not apply to Korea)
|
Drug: Entecavir
Tablets, Oral, 1mg, once daily, 100 weeks
Drug: Tenofovir
Tablets, Oral, 300 mg, once daily
|
| Adefovir + Lamivudine: Active Comparator |
Drug: Adefovir
Tablets, Oral, 10mg, once daily, 100 weeks
Drug: Lamivudine
Tablets, Oral, 100mg, once daily, 100 weeks
|
| Entecavir + Adefovir: Active Comparator |
Drug: Entecavir
Tablets, Oral, 1mg, once daily, 100 weeks
Drug: Adefovir
Tablets, Oral, 10mg, once daily, 100 weeks
|
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: | Clinical.Trials@bms.com | |
| Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time. |
Hide Study Locations| United States, Connecticut | |
| University Of Connecticut Health Center | Terminated |
| Farmington, Connecticut, United States, 06030 | |
| Argentina, Santa Fe | |
| Local Institution | Recruiting |
| Rosario, Santa Fe, Argentina, S2000KDS | |
| Contact: Site 122 | |
| Australia, New South Wales | |
| Local Institution | Recruiting |
| Concord, New South Wales, Australia, 2139 | |
| Contact: Site 064 | |
| Canada, Alberta | |
| Local Institution | Recruiting |
| Calgary, Alberta, Canada, T2N 4N1 | |
| Contact: Site 108 | |
| Canada, British Columbia | |
| Local Institution | Recruiting |
| Vancouver, British Columbia, Canada, V5Z 1H2 | |
| Contact: Site 107 | |
| Greece | |
| Local Institution | Active, not recruiting |
| Athens, Greece, 11527 | |
| Hong Kong | |
| Local Institution | Recruiting |
| Shatin, Hong Kong, 30-32 | |
| Contact: Site 075 | |
| Local Institution | Not yet recruiting |
| Kowloon, Hong Kong, - | |
| Contact: Site 098 | |
| Local Institution | Not yet recruiting |
| Tai Po, Hong Kong, . | |
| Contact: Site 119 | |
| Local Institution | Recruiting |
| Hong Kong, Hong Kong, * | |
| Contact: Site 134 | |
| India | |
| Local Institution | Recruiting |
| Lucknow, India, 226014 | |
| Contact: Site 001 | |
| Local Institution | Recruiting |
| New Delhi, India, 110002 | |
| Contact: Site 002 | |
| Local Institution | Recruiting |
| Vellore, India, 632004 | |
| Contact: Site 060 | |
| Local Institution | Terminated |
| Ludhiana, India, 141001 | |
| Local Institution | Recruiting |
| Ahmedabad, India, 380006 | |
| Contact: Site 121 | |
| Local Institution | Recruiting |
| Chandigarh, India, 160012 | |
| Contact: Site 126 | |
| Local Institution | Recruiting |
| Indore, India, 452014 | |
| Contact: Site 140 | |
| Local Institution | Not yet recruiting |
| New Delhi, India, 110062 | |
| Contact: Site 141 | |
| Local Institution | Not yet recruiting |
| Mumbai, India, 400 008 | |
| Contact: Site 142 | |
| Indonesia | |
| Local Institution | Recruiting |
| Jakarta, Indonesia, 10350 | |
| Contact: Site 097 | |
| Italy | |
| Local Institution | Recruiting |
| Brescia, Italy, 25123 | |
| Contact: Site 037 | |
| Local Institution | Recruiting |
| Antella Firenze, Italy, 50012 | |
| Contact: Site 038 | |
| Local Institution | Not yet recruiting |
| Roma, Italy, 00149 | |
| Contact: Site 068 | |
| Korea, Republic of | |
| Local Institution | Recruiting |
| Seoul, Korea, Republic of, 110-744 | |
| Contact: Site 080 | |
| Local Institution | Recruiting |
| Seoul, Korea, Republic of, 152-703 | |
| Contact: Site 081 | |
| Local Institution | Recruiting |
| Seoul, Korea, Republic of, 135-710 | |
| Contact: Site 090 | |
| Local Institution | Recruiting |
| Seoul, Korea, Republic of, 138-736 | |
| Contact: Site 095 | |
| Local Institution | Recruiting |
| Daegu, Korea, Republic of, 700-712 | |
| Contact: Site 092 | |
| Local Institution | Recruiting |
| Pusan, Korea, Republic of, 602-739 | |
| Contact: Site 093 | |
| Local Institution | Recruiting |
| Suwon, Korea, Republic of, 443-721 | |
| Contact: Site 094 | |
| Local Institution | Recruiting |
| Seoul, Korea, Republic of, 120-752 | |
| Contact: Site 091 | |
| Local Institution | Recruiting |
| Seoul, Korea, Republic of, 135-720 | |
| Contact: Site 117 | |
| Local Institution | Recruiting |
| Seoul, Korea, Republic of, 136-705 | |
| Contact: Site 123 | |
| Local Institution | Recruiting |
| Seoul, Korea, Republic of, 143-729 | |
| Contact: Site 124 | |
| Local Institution | Recruiting |
| Seoul, Korea, Republic of, 156-755 | |
| Contact: Site 125 | |
| Local Institution | Recruiting |
| Seoul, Korea, Republic of, 137-040 | |
| Contact: Site 130 | |
| Local Institution | Recruiting |
| Pusan, Korea, Republic of, 626770 | |
| Contact: Site 137 | |
| Local Institution | Recruiting |
| Bucheon, Korea, Republic of, 420767 | |
| Contact: Site 139 | |
| Local Institution | Recruiting |
| Sungnam, Korea, Republic of, 463-712 | |
| Contact: Site 143 | |
| Korea, Republic of, Amdong-Gu | |
| Local Institution | Recruiting |
| Incheon, Amdong-Gu, Korea, Republic of, 405-760 | |
| Contact: Site 146 | |
| Korea, Republic of, Dongdaemun-Gu | |
| Local Institution | Recruiting |
| Seoul, Dongdaemun-Gu, Korea, Republic of, 130-702 | |
| Contact: Site 133 | |
| Korea, Republic of, Donggu | |
| Local Institution | Recruiting |
| Ulsan, Donggu, Korea, Republic of, 682-714 | |
| Contact: Site 144 | |
| Korea, Republic of, Gangwon-Do | |
| Local Institution | Recruiting |
| Chuncheon-Si, Gangwon-Do, Korea, Republic of, 200-704 | |
| Contact: Site 132 | |
| Local Institution | Not yet recruiting |
| Wonju, Gangwon-Do, Korea, Republic of, 220-701 | |
| Contact: Site 145 | |
| Local Institution | Recruiting |
| Gangneung-Si, Gangwon-Do, Korea, Republic of, 210-711 | |
| Contact: Site 148 | |
| Korea, Republic of, Gyeonggi-Do | |
| Local Institution | Recruiting |
| Ansan-Si, Gyeonggi-Do, Korea, Republic of, 425-707 | |
| Contact: Site 129 | |
| Local Institution | Recruiting |
| Suwon-Si, Gyeonggi-Do, Korea, Republic of, 442-723 | |
| Contact: Site 131 | |
| Local Institution | Recruiting |
| Anyang-Si, Gyeonggi-Do, Korea, Republic of, 431-070 | |
| Contact: Site 147 | |
| Korea, Republic of, Ilsanseo-Gu | |
| Local Institution | Recruiting |
| Goyang, Ilsanseo-Gu, Korea, Republic of, 414-410 | |
| Contact: Site 138 | |
| Korea, Republic of, Jung-Gu | |
| Local Institution | Recruiting |
| Incheon, Jung-Gu, Korea, Republic of, 400-711 | |
| Contact: Site 136 | |
| Korea, Republic of, Nowon-Gu | |
| Local Institution | Recruiting |
| Seoul, Nowon-Gu, Korea, Republic of, 139872 | |
| Contact: Site 135 | |
| Malaysia | |
| Local Institution | Recruiting |
| Kuala Lumpur, Malaysia, 50603 | |
| Contact: Site 076 | |
| Malaysia, Sabah | |
| Local Institution | Recruiting |
| Kota Kinabalu, Sabah, Malaysia, 88586 | |
| Contact: Site 110 | |
| Philippines | |
| Local Institution | Recruiting |
| Cebu City, Philippines, 6000 | |
| Contact: Site 099 | |
| Local Institution | Recruiting |
| Manila, Philippines, 1502 | |
| Contact: Site 120 | |
| Poland | |
| Local Institution | Recruiting |
| Lodzi, Poland, 91-347 | |
| Contact: Site 007 | |
| Local Institution | Recruiting |
| Kielce, Poland, 25-317 | |
| Contact: Site 008 | |
| Local Institution | Recruiting |
| Chorzow, Poland, 41-500 | |
| Contact: Site 031 | |
| Local Institution | Not yet recruiting |
| Bialystok, Poland, 15-540 | |
| Contact: Site 013 | |
| Local Institution | Recruiting |
| Krakow, Poland, 31-531 | |
| Contact: Site 016 | |
| Local Institution | Recruiting |
| Lublin, Poland, 20-081 | |
| Contact: Site 017 | |
| Local Institution | Recruiting |
| Warszawa, Poland, 01-201 | |
| Contact: Site 010 | |
| Russian Federation | |
| Local Institution | Not yet recruiting |
| St. Petersburg, Russian Federation, 191163 | |
| Contact: Site 042 | |
| Local Institution | Recruiting |
| Moscow, Russian Federation, 115446 | |
| Contact: Site 043 | |
| Local Institution | Not yet recruiting |
| Moscow, Russian Federation, 117593 | |
| Contact: Site 044 | |
| Local Institution | Recruiting |
| St. Petersburg, Russian Federation, 191167 | |
| Contact: Site 046 | |
| Local Institution | Not yet recruiting |
| St. Petersburg, Russian Federation, 194044 | |
| Contact: Site 047 | |
| Local Institution | Recruiting |
| St. Petersburg, Russian Federation, 190103 | |
| Contact: Site 048 | |
| Local Institution | Recruiting |
| Moscow, Russian Federation, 129110 | |
| Contact: Site 049 | |
| Local Institution | Recruiting |
| Moscow, Russian Federation, 105275 | |
| Contact: Site 050 | |
| Local Institution | Recruiting |
| Moscow, Russian Federation, 105275 | |
| Contact: Site 056 | |
| Local Institution | Recruiting |
| St. Petersburg, Russian Federation, 191167 | |
| Contact: Site 127 | |
| Singapore | |
| Local Institution | Recruiting |
| Singapore, Singapore, 119074 | |
| Contact: Site 083 | |
| Taiwan | |
| Local Institution | Recruiting |
| Taipei, Taiwan, 100 | |
| Contact: Site 086 | |
| Local Institution | Recruiting |
| Tainan R.o.c., Taiwan, 70403 | |
| Contact: Site 087 | |
| Local Institution | Recruiting |
| Kaohsiung, Taiwan, 80756 | |
| Contact: Site 088 | |
| Local Institution | Recruiting |
| Taoyuan, Taiwan, 333 | |
| Contact: Site 118 | |
| Thailand | |
| Local Institution | Recruiting |
| Chiang Mai, Thailand, 50200 | |
| Contact: Site 082 | |
| Local Institution | Recruiting |
| Bangkok, Thailand, 10160 | |
| Contact: Site 084 | |
| Turkey | |
| Local Institution | Recruiting |
| Bornova Izmir, Turkey, 35100 | |
| Contact: Site 034 | |
| Local Institution | Not yet recruiting |
| Besevler Ankara, Turkey, 06620 | |
| Contact: Site 079 | |
| Local Institution | Recruiting |
| Trabzon, Turkey, 61080 | |
| Contact: Site 089 | |
| Local Institution | Not yet recruiting |
| Kayseri, Turkey, 38039 | |
| Contact: Site 104 | |
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
| Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
| Study ID Numbers: | AI463-111 |
| Study First Received: | December 11, 2006 |
| Last Updated: | November 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00410202 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Anti-Infective Agents Liver Diseases Hepatitis, Chronic Molecular Mechanisms of Pharmacological Action Lamivudine Hepatitis, Viral, Human Hepadnaviridae Infections Reverse Transcriptase Inhibitors Entecavir Anti-Retroviral Agents Hepatitis B, Chronic Therapeutic Uses Hepatitis B |
Tenofovir Nucleic Acid Synthesis Inhibitors Anti-HIV Agents Enzyme Inhibitors Antiviral Agents Pharmacologic Actions Virus Diseases Hepatitis Digestive System Diseases Adefovir dipivoxil DNA Virus Infections Adefovir |