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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2008-006933-29 |
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| Name | Class |
|---|---|
| Human Genome Sciences Inc. | INDUSTRY |
This study will assess the efficacy of ABF656 in chronic hepatitis B characterized by HBeAg positivity. The study is designed to establish a dose response and safety relationship sufficient to allow the subsequent design and conduct of Phase 3 trials. The trial is also designed to generate the PK data in hepatitis B patients to satisfy regulatory requirements in China.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 ABF656 900ug Q2w | Experimental |
| |
| Group 2 ABF656 900ug Q4w | Experimental |
| |
| Group 3 AB656 1200ug Q4w | Experimental |
| |
| Group 4 ABF656 1500ug Q4w | Experimental |
| |
| Group 5 Pegasys® 180µg qw | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| albinterferon alfa-2b | Drug |
| ||
| albinterferon alfa-2b |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety, tolerability and pharmacodynamic effect of various doses of albinterferon alfa-2b in hepatitis B patients on seroconversion of hepatitis markers. Measure: Clinical laboratory. HBV DNA level and HBeAg seroconversion rate. | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the pharmacokinetics at different doses of albinterferon alfa-2b in patients with chronic hepatitis B infection. Measure: Serum concentration of albinterferon alfa-2b | up to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Institutes for BioMedical Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigator Site | Beijing | China | ||||
| Novartis Investigator Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12823597 | Background | Cooksley WG, Piratvisuth T, Lee SD, Mahachai V, Chao YC, Tanwandee T, Chutaputti A, Chang WY, Zahm FE, Pluck N. Peginterferon alpha-2a (40 kDa): an advance in the treatment of hepatitis B e antigen-positive chronic hepatitis B. J Viral Hepat. 2003 Jul;10(4):298-305. doi: 10.1046/j.1365-2893.2003.00450.x. | |
| 24995515 | Derived |
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| Drug |
|
| albinterferon alfa-2b | Drug |
|
| albinterferon alfa-2b | Drug |
|
| Pegasys® | Drug |
|
| Shatin |
| Hong Kong |
| Novartis Investigator Site | Taipo | Hong Kong |
| Novartis Investigator Site | Bialystok | Poland |
| Novartis Investigator Site | Lodz | Poland |
| Novartis Investigator Site | Warsaw | Poland |
| Novartis Investigator Site | Kaohsiung City | Taiwan |
| Novartis Investigator Site | Taipei | Taiwan |
| Novartis Investigator Site | Tau-Yuan County | Taiwan |
| Novartis Investigator Site | Bangkok | Thailand |
| Novartis Investigator Site | Chiang Mai | Thailand |
| Novartis Investigator Site | Songkhla | Thailand |
| Colvin RA, Tanwandee T, Piratvisuth T, Thongsawat S, Hui AJ, Zhang H, Ren H, Chen PJ, Chuang WL, Sobhonslidsuk A, Li R, Qi Y, Praestgaard J, Han Y, Xu J, Stein DS; ABF656A2206 Study Group. Randomized, controlled pharmacokinetic and pharmacodynamic evaluation of albinterferon in patients with chronic hepatitis B infection. J Gastroenterol Hepatol. 2015 Jan;30(1):184-91. doi: 10.1111/jgh.12671. |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| D006509 | Hepatitis B |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C531108 | albinterferon alfa-2b |
| C100416 | peginterferon alfa-2a |
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