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| Name | Class |
|---|---|
| CytoPharm, Inc. | INDUSTRY |
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The purpose of this study is to determine whether lozenges of interferon-alpha that are dissolved in the mouth can prevent relapse in patients with hepatitis C virus infection who had a complete virologic response after receiving a combination of injected interferon-alpha and oral ribavirin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 500 IU qd | Experimental | 500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day |
|
| 500 IU tid | Experimental | 500 IU interferon-alpha lozenge taken 3 times per day |
|
| placebo | Placebo Comparator | placebo lozenges taken 3 times per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| interferon-alpha lozenges | Drug | 500 IU lozenges of natural human interferon-alpha for oral dissolution given once or three times per day for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relapse Rate | Percentage of participants with a positive seum HCV RNA level at any post-baseline evaluation Serum HCV RNA was tested using a commercially available real-time polymerase-chain-reaction (PCR) assay kit (Roche Cobas TaqMan HCV assay kit) with a limit of detection of 15 IU/ml. | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained Virologic Response Rate | Percentage of participants who remained HCV RNA negative throughout the study | 48 weeks |
| Normalization of ALT | Percentage of participants with a normal serum ALT level at the end of the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dalin Buddhist Tzu Chi General Hospital | Dalin | Chiayi County | Taiwan | |||
| Kaohsiung Chang Gung Memorial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24237300 | Derived | Lee CM, Chen CY, Chien RN, Tseng KC, Peng CY, Tung SY, Fang YJ, Huang YH, Lu SN, Hung CH, Tsai TJ, Fang CC, Hsu CW, Yeh CT. A double-blind randomized controlled study to evaluate the efficacy of low-dose oral interferon-alpha in preventing hepatitis C relapse. J Interferon Cytokine Res. 2014 Mar;34(3):187-94. doi: 10.1089/jir.2013.0074. Epub 2013 Nov 15. |
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A total of 196 subjects were screened. All 169 subjects meeting eligibility criteria were randomized to one of the 3 treatment groups and all 169 were included in the intent-to-treat analysis.
Subjects undergoing treatment for HCV infection at one of the 9 participating hospitals were approached, and those willing to sign informed consent were screened for eligibility.
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| ID | Title | Description |
|---|---|---|
| FG000 | 500 IU qd | 500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges |
| FG001 | 500 IU Tid | 500 IU interferon-alpha lozenge taken 3 times per day |
| FG002 | Placebo | placebo lozenges taken 3 times per day |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 500 IU qd | 500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges |
| BG001 | 500 IU Tid | 500 IU interferon-alpha lozenge taken 3 times per day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Sustained Virologic Response Rate | Percentage of participants who remained HCV RNA negative throughout the study | Intent-to-treat | Posted | Number | percentage of participants | 48 weeks |
|
48 weeks
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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 | 500 IU qd | 500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever and loss of consciousness | Infections and infestations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Martin J. Cummins, Director of Clinical & Regulatory Affairs | Amarillo Biosciences, Inc. | 806-376-1741 | 14 | mcummins@amarbio.com |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D016898 | Interferon-alpha |
| D007372 | Interferons |
| ID | Term |
|---|---|
| D007370 | Interferon Type I |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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|
| placebo lozenges | Drug | 200 mg matching placebo lozenges |
|
|
| 48 weeks |
| Change in Serum HCV RNA Concentration | Change in serum HCV RNA concentration (log10 IU) from baseline to week 48 | 48 weeks |
| Change in Serum ALT | Change in Serum ALT concentration from baseline to week 48 | 48 weeks |
| Change in Social Functioning | Change in the Social Functioning domain of the SF-36 quality-of-life questionnaire from baseline to week 48 Social Functioning (SF) scores range from 0-100, with lower scores indicating that health/emotional problems have had a greater negative impact on social activities, compared to higher scores. SF scores are calculated using a proprietary algorithm based on responses to questions #6 and #10 on the SF-36, which are 5-point likert scales about the extent to which, and the amount of time with which physical or emotional problems have interfered with social activities. | 48 weeks |
| Change in Fibrotest Score | Change in fibrotest score from baseline to week 48 | 48 weeks |
| Niaosong |
| Kaosiung County |
| Taiwan |
| Show-Chwan Memorial Hospital | Changhua | Taiwan |
| Chiayi Chang Gung Memorial Hospital | Chiayi City | Taiwan |
| Chiayi Christian Hospital | Chiayi City | Taiwan |
| Keelung Chang Gung Memorial Hospital | Keelung | Taiwan |
| China Medical University Hospital | Taichung | Taiwan |
| Chang Gung Memorial Hospital | Taipei | 105 | Taiwan |
| Taipei Veterans General Hospital | Taipei | Taiwan |
| Lack of Efficacy |
|
| Various |
|
| BG002 | Placebo | placebo lozenges taken 3 times per day |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
placebo lozenges taken 3 times per day
|
|
|
| Secondary | Normalization of ALT | Percentage of participants with a normal serum ALT level at the end of the study | Intent-to-treat | Posted | Number | percentage of participants | 48 weeks |
|
|
|
|
| Secondary | Change in Serum HCV RNA Concentration | Change in serum HCV RNA concentration (log10 IU) from baseline to week 48 | Intent-to-treat population | Posted | Log Mean | Standard Deviation | log10 IU | 48 weeks |
|
|
|
|
| Secondary | Change in Serum ALT | Change in Serum ALT concentration from baseline to week 48 | Intent-to-treat | Posted | Mean | Standard Deviation | U/L | 48 weeks |
|
|
|
|
| Primary | Relapse Rate | Percentage of participants with a positive seum HCV RNA level at any post-baseline evaluation Serum HCV RNA was tested using a commercially available real-time polymerase-chain-reaction (PCR) assay kit (Roche Cobas TaqMan HCV assay kit) with a limit of detection of 15 IU/ml. | Intent-to-treat | Posted | Number | percentage of participants | 48 weeks |
|
|
|
|
| Secondary | Change in Social Functioning | Change in the Social Functioning domain of the SF-36 quality-of-life questionnaire from baseline to week 48 Social Functioning (SF) scores range from 0-100, with lower scores indicating that health/emotional problems have had a greater negative impact on social activities, compared to higher scores. SF scores are calculated using a proprietary algorithm based on responses to questions #6 and #10 on the SF-36, which are 5-point likert scales about the extent to which, and the amount of time with which physical or emotional problems have interfered with social activities. | Intent-to-treat | Posted | Mean | Standard Deviation | change in score | 48 weeks |
|
|
|
|
| Secondary | Change in Fibrotest Score | Change in fibrotest score from baseline to week 48 | Posted | Mean | Standard Deviation | units on a scale | 48 weeks |
|
|
|
|
| Post-Hoc | Normalization of Platelets | Percentage of participants with a low platelet count at baseline who had a normal platelet count at the end of the study | Participants with a baseline platelet count below 150 who were evaluable for response at week 48 were included in the analysis | Posted | Number | percentage of participants | 48 weeks |
|
|
|
|
| 2 |
| 59 |
| 52 |
| 59 |
| EG001 | 500 IU Tid | 500 IU interferon-alpha lozenge taken 3 times per day | 6 | 53 | 46 | 53 |
| EG002 | Placebo | placebo lozenges taken 3 times per day | 6 | 57 | 41 | 57 |
| Esophageal ulcers with bleeding | Gastrointestinal disorders | Non-systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | Non-systematic Assessment |
|
| Cirrhotic liver nodule | Gastrointestinal disorders | Non-systematic Assessment |
|
| Worsening of benign prostate hyperplasia | Renal and urinary disorders | Non-systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Influenza | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Gastric ulcers and anemia | Gastrointestinal disorders | Non-systematic Assessment |
|
| right knee arthritis with synovitis | Nervous system disorders | Non-systematic Assessment |
|
| Right middle cerebral artery infarction | Vascular disorders | Non-systematic Assessment |
|
| Thoracic aortic aneurysm | Cardiac disorders | Non-systematic Assessment |
|
| Dizziness with associated nausea and vomiting | Nervous system disorders | Non-systematic Assessment |
|
| Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Insomnia | Nervous system disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Abdominal Distension | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Irritable Bowel Syndrome | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Bile Duct Stone | Renal and urinary disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Malaise | General disorders | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | Non-systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Myositis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | Non-systematic Assessment |
|
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| D006525 |
| Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| 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 |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| 95 |
| Superiority or Other (legacy) |