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The purpose of this protocol is to obtain pharmacodynamic and pharmacokinetic data on ABI-H0731 and to provide the opportunity for preliminary evaluation of combination therapy of ABI-H0731 with currently approved antiviral treatment for chronic hepatitis B.
The Phase 1b/2a assessments of the dose-related safety, PK, and initial antiviral efficacy of ABI-H0731 in hepatitis B patients will be conducted at approximately 17 different sites to meet enrollment goals of 108 chronic hepatitis B patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort B1 | Experimental | ABI-H0731 or Placebo in varying doses by mouth for 28 days |
|
| Cohort B2 | Experimental | ABI-H0731 or Placebo in varying doses by mouth for 28 days |
|
| Cohort B3 | Experimental | ABI-H0731 or Placebo in varying doses by mouth for 28 days |
|
| Cohort B4 | Experimental | ABI-H0731 or Placebo in varying doses by mouth for 28 days |
|
| Cohort B5 | Experimental | ABI-H0731 or Placebo in combination with entecavir or tenofovir for 28 days |
|
| Cohort B6 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABI-H0731 | Drug | A novel HBV core protein allosteric modifier (CpAM) which is being developed as a potential therapeutic advance for CHB patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with chronic HBV infection with treatment-related adverse events and laboratory abnormalities as assessed by CTCAE v4.0. | Up to 57 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Monash University | Clayton | Victoria | Australia | |||
| St. Vincent's Hospital |
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ABI-H0731 or Placebo, in combination with a commerically-approved nucleos(t)ide plus PegIFN in treatment-experienced patients, for 28 days |
|
| Placebo for ABI-H0731 | Drug | Sugar pill manufactured to mimic the ABI-H0731 tablet |
|
| Entecavir | Drug | An antiviral medication used in the treatment of hepatitis B virus infection |
|
|
| Tenofovir Disoproxil Fumarate | Drug | An antiviral medication used in the treatment of hepatitis B virus infection |
|
|
| Pegasys | Drug | Used to treat adults with chronic hepatitis B virus who show signs of liver damage |
|
|
| Fitzroy |
| Victoria |
| Australia |
| The Alfred Hospital | Melbourne | Victoria | Australia |
| Linear Clinical Research | Nedlands | Western Australia | Australia |
| University of Hong Kong | Hong Kong | Hong Kong |
| Hallym University | Chuncheon | South Korea |
| CHA Bundang Medical Center | Gyeonggi-do | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Severance Hospital, Yonsei University | Seoul | South Korea |
| Keelung Chang Gung Memorial Hospital | Keelung | Taiwan |
| National Taiwan University Hospital | Taipei | Taiwan |
| King's College Hospital | London | United Kingdom |
| Royal Free Hospital NHS Foundation Trust | London | United Kingdom |
| Royal London Hospital | London | United Kingdom |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| 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 |
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| ID | Term |
|---|---|
| C413685 | entecavir |
| D000068698 | Tenofovir |
| C100416 | peginterferon alfa-2a |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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