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Did not meet endpoints
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A study to evaluate the antiviral effects, immunogenicity, and safety of HepTcell in treatment-naive patients with inactive chronic hepatitis B (CHB) and low hepatitis B surface antigen (HBsAg) levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HepTcell | Experimental | Dose administered at intervals of 4 weeks for 6 doses |
|
| Placebo | Placebo Comparator | Dose administered at intervals of 4 weeks for 6 doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HepTcell | Biological | Intramuscular injection |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Patients Achieving Virologic Responses | Virologic response is defined as a 1.0-log reduction in quantitative hepatitis B surface antigen (HBsAg) or serologic clearance of HBsAg from Baseline to Day 169 | Baseline to Day 169 |
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Patients Achieving Serologic Clearance of Hepatitis B Surface Antigen (HBsAg) on Day 169 | Baseline to Day 169 | |
| The Proportion of Patients Achieving Serologic Clearance of Hepatitis B Virus (HBV) DNA on Day 169 | Baseline to Day 169 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paragon Rx Clinical | Garden Grove | California | 92840 | United States | ||
| Stanford University Department of Medicine |
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| ID | Title | Description |
|---|---|---|
| FG000 | HepTcell | Dose administered at intervals of 4 weeks for 6 doses HepTcell: Intramuscular injection |
| FG001 | Placebo | Dose administered at intervals of 4 weeks for 6 doses Placebo: Intramuscular injection |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 24, 2022 | Jul 24, 2024 |
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| Drug |
Intramuscular injection |
|
| Changes in Quantitative HBsAg Level | Baseline to Days 85 and 169 |
| Changes in HBV DNA Levels | Baseline to Days 85 and 169 |
| Changes in Hepatitis B Core-related Antigen (HBCrAg) Levels | Baseline to Days 85 and 169 |
| Changes in Pre-genomic RNA Levels | Baseline to Days 85 and 169 |
| Change in IFN-gamma Frequency by ELISpot Assay in PBMCs | Percent change in antigen-specific spot forming cells per million peripheral blood mononuclear cells (PBMCs) | Baseline to Days 85 and 169 |
| Redwood City |
| California |
| 94063 |
| United States |
| San Jose Gastroenterology Institute | San Jose | California | 95128 | United States |
| Kansas City Research Institute | Kansas City | Missouri | 64131 | United States |
| Central Sooner Research | Oklahoma City | Oklahoma | 73071 | United States |
| University of Calgary Liver Unit - Heritage Medical Research Clinic | Calgary | Alberta | T2N 4Z6 | Canada |
| University of Alberta Hospital | Edmonton | Alberta | T6G 2G3 | Canada |
| The Ottawa Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| Toronto Centre for Liver Disease (TCLD), Toronto General Hospital, UHN | Toronto | Ontario | M5G 2C4 | Canada |
| Toronto Liver Centre | Toronto | Ontario | M6H 3M1 | Canada |
| Goethe University Hospital | Frankfurt am Main | 60590 | Germany |
| Univesritätsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Hospital Clínic De Barcelona | Barcelona | 08028 | Spain |
| Hospital Universitari Vall D'Hebron | Barcelona | 08035 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Nuestra Señora De Valme | Seville | 41014 | Spain |
| Consorcio Hospital General Universitario De Valencia | Valencia | 46014 | Spain |
| Hospital Universitari I Politècnic La Fe | Valencia | 46026 | Spain |
| St. Georges University of London | London | SW17 0RE | United Kingdom |
| St. Mary's Hospital | London | W2 1NY | United Kingdom |
| Queens Medical Center | Nottingham | NG7 2UH | United Kingdom |
| Treated | One subject randomized to HepTcell and 2 subjects randomized to placebo discontinued before receiving study treatment |
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| COMPLETED |
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| NOT COMPLETED |
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mITT population: all randomized subjects who received any amount of study medication and had a baseline and at least one postbaseline efficacy assessment
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| ID | Title | Description |
|---|---|---|
| BG000 | HepTcell | Dose administered at intervals of 4 weeks for 6 doses HepTcell: Intramuscular injection |
| BG001 | Placebo | Dose administered at intervals of 4 weeks for 6 doses Placebo: Intramuscular injection |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Proportion of Patients Achieving Virologic Responses | Virologic response is defined as a 1.0-log reduction in quantitative hepatitis B surface antigen (HBsAg) or serologic clearance of HBsAg from Baseline to Day 169 | mITT population | Posted | Count of Participants | Participants | Baseline to Day 169 |
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| Secondary | The Proportion of Patients Achieving Serologic Clearance of Hepatitis B Surface Antigen (HBsAg) on Day 169 | mITT | Posted | Count of Participants | Participants | Baseline to Day 169 |
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| Secondary | The Proportion of Patients Achieving Serologic Clearance of Hepatitis B Virus (HBV) DNA on Day 169 | mITT | Posted | Count of Participants | Participants | Baseline to Day 169 |
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| Secondary | Changes in Quantitative HBsAg Level | mITT. Number analyzed are the number of participants with data at each time point. Changes from baseline are calculated only for participants with non-missing values for both the baseline and time point of interest. | Posted | Mean | Standard Deviation | IU/mL | Baseline to Days 85 and 169 |
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| Secondary | Changes in HBV DNA Levels | mITT. Number analyzed are the number of participants with data at each time point. Changes from baseline are calculated only for participants with non-missing values for both the baseline and time point of interest. | Posted | Mean | Standard Deviation | IU/mL | Baseline to Days 85 and 169 |
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| Secondary | Changes in Hepatitis B Core-related Antigen (HBCrAg) Levels | mITT. Number analyzed are the number of participants with data at each time point. Changes from baseline are calculated only for participants with non-missing values for both the baseline and time point of interest. | Posted | Mean | Standard Deviation | kU/mL | Baseline to Days 85 and 169 |
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| Secondary | Changes in Pre-genomic RNA Levels | mITT. Number analyzed are the number of participants with data at each time point. Changes from baseline are calculated only for participants with non-missing values for both the baseline and time point of interest. | Posted | Mean | Standard Deviation | Log U/mL | Baseline to Days 85 and 169 |
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| Secondary | Change in IFN-gamma Frequency by ELISpot Assay in PBMCs | Percent change in antigen-specific spot forming cells per million peripheral blood mononuclear cells (PBMCs) | mITT. Number analyzed are the number of participants with data at each time point. Changes from baseline are calculated only for participants with non-missing values for both the baseline and time point of interest. | Posted | Mean | Standard Deviation | percent change | Baseline to Days 85 and 169 |
|
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HepTcell | Dose administered at intervals of 4 weeks for 6 doses HepTcell: Intramuscular injection | 0 | 41 | 0 | 41 | 19 | 41 |
| EG001 | Placebo | Dose administered at intervals of 4 weeks for 6 doses Placebo: Intramuscular injection | 0 | 43 | 0 | 43 | 29 | 43 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 25.1 | Non-systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
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| Food poisoning | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
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| Influenza A virus test positive | Investigations | MedDRA 25.1 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 25.1 | Non-systematic Assessment |
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| Limb injury | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | MedDRA 25.1 | Non-systematic Assessment |
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| Iron deficiency | Metabolism and nutrition disorders | MedDRA 25.1 | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA 25.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Randy Brown | Altimmune | 3179003335 | rbrown@altimmune.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 22, 2024 | Aug 29, 2024 | SAP_001.pdf |
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| 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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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| United States |
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| United Kingdom |
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| Germany |
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| Spain |
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| Thailand |
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| Italy |
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| Superiority |
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