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The purpose of the study is to evaluate if continuous subcutaneous delivery of interferon alfa-2b using an external drug pump in combination with the use of oral ribavirin provides a safe and effective treatment for patients with chronic hepatitis C infection as compared to patients who receive standard treatment.
The study will include patients who are diagnosed with chronic hepatitis C genotype 1 infection and who have received no previous interferon or other anti-HCV treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: interferon alfa-2b (dose 1) | Experimental | continuous subcutaneous infusion for 48 weeks |
|
| Group 2: interferon alfa-2b (dose 2) | Experimental | continuous subcutaneous infusion for 48 weeks |
|
| Group 3: interferon alfa-2b (dose 3) | Experimental | continuous subcutaneous infusion for 48 weeks |
|
| Group 4: peginterferon alfa-2b (1.5 μg/kg) | Active Comparator | subcutaneous weekly for 48 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| interferon alfa-2b | Drug | subcutaneous continuous infusion at one of three doses for 48 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Viral Load: Incidence of Sustained Virologic Response (SVR) | 24 weeks after treatment is complete |
| Measure | Description | Time Frame |
|---|---|---|
| Rapid Virologic Response (RVR) | Study Week 4 | |
| Early Virologic Response (EVR) | Study week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Muir, M.D. | Duke Clinical Research Institute | Principal Investigator |
| Sarah Mische, PhD | Medtronic Ventures and New Therapies | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Clinical Research Institute | Durham | North Carolina | 27705 | United States |
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| Label | URL |
|---|---|
| Common terminology criteria for adverse events, version 3.0 | View source |
| International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals: writing and editing for biomedical publication. Publication ethics: sponsorship, authorship and accountability. | View source |
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210 screened, 116 randomized, 106 received at least 1 dose of study drug.
Enrollment 09-Jun-2009, final subject complete 19-Jun-2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 4: Peginterferon Alfa-2b (1.5 μg/kg) | subcutaneous weekly for 48 weeks peginterferon alfa-2b : 1.5 μg/kg subcutaneous weekly for 48 weeks ribavirin, USP : All patients will receive oral ribavirin |
| FG001 | Group 1: Interferon Alfa-2b (Dose 1) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| peginterferon alfa-2b | Drug | 1.5 μg/kg subcutaneous weekly for 48 weeks |
|
|
| ribavirin, USP | Drug | All patients will receive oral ribavirin |
|
|
| external drug infusion pump | Device | pump delivery system for continuous subcutaneous infusion of interferon alfa-2b |
|
|
continuous subcutaneous infusion for 48 weeks external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks ribavirin, USP : All patients will receive oral ribavirin |
| FG002 | Group 2: Interferon Alfa-2b (Dose 2) | continuous subcutaneous infusion for 48 weeks external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks ribavirin, USP : All patients will receive oral ribavirin |
| FG003 | Group 3: Interferon Alfa-2b (Dose 3) | continuous subcutaneous infusion for 48 weeks external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks ribavirin, USP : All patients will receive oral ribavirin |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 4: Peginterferon Alfa-2b (1.5 μg/kg) | subcutaneous weekly for 48 weeks peginterferon alfa-2b : 1.5 μg/kg subcutaneous weekly for 48 weeks ribavirin, USP : All patients will receive oral ribavirin |
| BG001 | Group 1: Interferon Alfa-2b (Dose 1) | continuous subcutaneous infusion for 48 weeks external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks ribavirin, USP : All patients will receive oral ribavirin |
| BG002 | Group 2: Interferon Alfa-2b (Dose 2) | continuous subcutaneous infusion for 48 weeks external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks ribavirin, USP : All patients will receive oral ribavirin |
| BG003 | Group 3: Interferon Alfa-2b (Dose 3) | continuous subcutaneous infusion for 48 weeks external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks ribavirin, USP : All patients will receive oral ribavirin |
| BG004 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Hepatitis C Genotype | 1a, 1b | Number | 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 | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Viral Load: Incidence of Sustained Virologic Response (SVR) | Posted | Number | participants | 24 weeks after treatment is complete |
|
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Rapid Virologic Response (RVR) | Posted | Number | participants | Study Week 4 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Early Virologic Response (EVR) | Posted | Number | participants | Study week 12 |
|
Adverse events were collected the duration of the study from activation to closure.
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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 | PEGINTRON 1.5 | subcutaneous weekly for 48 weeks peginterferon alfa-2b : 1.5 μg/kg subcutaneous weekly for 48 weeks ribavirin, USP : All patients will receive oral ribavirin | 2 | 28 | 28 | 28 | ||
| EG001 | INTRON A 80,000 | continuous subcutaneous infusion for 48 weeks external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks ribavirin, USP : All patients will receive oral ribavirin | 6 | 25 | 25 | 25 | ||
| EG002 | INTRON A 120,000 | continuous subcutaneous infusion for 48 weeks external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks ribavirin, USP : All patients will receive oral ribavirin | 5 | 27 | 27 | 27 | ||
| EG003 | INTRON A 160,000 | continuous subcutaneous infusion for 48 weeks external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks ribavirin, USP : All patients will receive oral ribavirin | 6 | 26 | 26 | 26 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Injection Site Cellulitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Staphylococcal Abscess | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pneumonia Moraxella | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Streptococcal Abscess | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Suicidal Ideation | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Suicide Attempt | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Arteriosclerosis Coronary Artery | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypertensive Heart Disease | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Liver Disorder | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Type 2 Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Influenza Like Illness | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gingival Pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Disturbance in Attention | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Memory Impairment | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypersomnia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypogeusia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Respiratory Tract Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Libido Decreased | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Blood Uric Acid Increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Visual Acuity Reduced | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dry Eye | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Eye Pain | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Retinal Exudates | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Angina Pectoris | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Techycardia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Ear Pain | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Trial Manager | Medtronic, Inc. | 763-505-4594 | sarah.mische@medtronic.com |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
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| ID | Term |
|---|---|
| D000077190 | Interferon alpha-2 |
| C417083 | peginterferon alfa-2b |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D016898 | Interferon-alpha |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 1b |
|
|
|
continuous subcutaneous infusion for 48 weeks
external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b
interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks
ribavirin, USP : All patients will receive oral ribavirin
|
|