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| ID | Type | Description | Link |
|---|---|---|---|
| R34HL109334 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Vertex Pharmaceuticals Incorporated | INDUSTRY |
| Genentech, Inc. | INDUSTRY |
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This study will examine viral dynamic responses in subjects with chronic hepatitis C and hemophilia when treated with pegylated interferon + ribavirin and telaprevir.
Previous clinical trials for treatment of chronic hepatitis C have excluded subjects with hemophilia from participating.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lead-In | Active Comparator | Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin for 4 weeks followed by 12 weeks of PegInterferon + Ribavirin + Telaprevir followed by variable duration of PegInterferon + Ribavirin |
|
| No Lead-in | Active Comparator | Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration of PegIntereron + Ribavirin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PegInterferon | Drug |
| ||
| Ribavirin |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Sustained Virological Response at Week 12 (SVR12) | Viral kinetic assessment using SVR 12 to either "lead-in" 4 weeks with PegInterferon + Ribavirin or no lead-in, followed by response guided therapy of 24 or 48 weeks based on viral response to treatment. Standard of care treatment stopping rules will be followed with assessment of viral response at week 12 of treatment. | Post-treatment at week 12 |
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Inclusion Criteria:
Exclusion Criteria:
Hemoglobin <11
Pregnancy (during screening period or any time during treatment)
HIV Infection
Prior History of:
History of Decompensated liver disease evidenced by any prior history of hepatic encephalopathy (Grade 2 or higher), ascites, variceal bleeding; Platelet count < 100,000
Active thyroid disease (OK if on thyroid replacement with normal thyroid-stimulating hormone (TSH); if TSH abnormal must have normal free thyroid index)
Chronic renal insufficiency, defined as creatinine clearance < 50 ml/min. (estimated by Modification of Diet in Renal Disease (MDRD) formula)
Life-threatening disease processes that could preclude completion of trial in opinion of investigator.
Any condition which the investigator feels will preclude safe completion of the treatment regimen including severe psychiatric disorders, active alcohol or recreational drug abuse.
Inability to provide informed consent.
Use of systemic corticosteroids or immunomodulatory drugs within 1 month (Nasal steroids are permitted.)
Uncontrolled seizure disorder (in opinion of investigator)
Concurrent autoimmune processes with active disease that may be exacerbated by interferon-based therapies (e.g. Crohn's Disease, Rheumatoid arthritis) in the opinion of the investigator. Psoriasis permitted if controlled with topical medications at the time of study enrollment.
Use of prohibited medications (as described in the telaprevir package insert) within 14 days of the first dose of study medications
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth E Sherman, MD, PhD | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Physicians Company | Cincinnati | Ohio | 45267 | United States |
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January 2013 through April 2014 at Digestive Diseases Research / University of Cincinnati
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| ID | Title | Description |
|---|---|---|
| FG000 | Lead-In | Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin for 4 weeks followed by 12 weeks of PegInterferon + Ribavirin + Telaprevir followed by variable duration of PegInterferon + Ribavirin |
| FG001 | No Lead-in | No 4 week lead-in: Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration of PegInterferon + Ribavirin |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lead-In | Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin for 4 weeks followed by 12 weeks of PegInterferon + Ribavirin + Telaprevir followed by variable duration of PegInterferon + Ribavirin. |
| BG001 | No Lead-in |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Number of Participants With Sustained Virological Response at Week 12 (SVR12) | Viral kinetic assessment using SVR 12 to either "lead-in" 4 weeks with PegInterferon + Ribavirin or no lead-in, followed by response guided therapy of 24 or 48 weeks based on viral response to treatment. Standard of care treatment stopping rules will be followed with assessment of viral response at week 12 of treatment. | See baseline characteristics | Posted | Number | participants | Post-treatment at week 12 |
|
Participants were assessed throughout their treatment intervention and through a 12 week followup period after completion of therapy, up to 60 weeks.
Adverse events were only collected with regard to the affected organ system. Specific Adverse Event Terms are unknown.
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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 | Lead-In | Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin for 4 weeks followed by 12 weeks of PegInterferon + Ribavirin + Telaprevir followed by variable duration of PegInterferon + Ribavirin |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anemia | Blood and lymphatic system disorders | DAIDS | Systematic Assessment | Not study drug related |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General disorders | General disorders | DAIDS | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kenneth E. Sherman, MD. PhD | University of Cincinnati | 513-558-3918 | kenneth.sherman@uc.edu |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006467 | Hemophilia A |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| D012254 | Ribavirin |
| C486464 | telaprevir |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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|
| Telaprevir | Drug |
|
No 4 week lead-in: Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration of PegInterferon + Ribavirin. |
| BG002 | Total | Total of all reporting groups |
| 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 |
|
| No Lead-in |
No 4 week lead-in: Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration PegInterferon + Ribavirin |
|
|
| 1 |
| 3 |
| 3 |
| 3 |
| EG001 | No Lead-in | No 4 week lead-in: Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration of PegInterferon + Ribavirin | 0 | 2 | 2 | 2 |
|
| Gastrointestinal disorders | Gastrointestinal disorders | DAIDS | Systematic Assessment |
|
| Skin and sucutaneous-tissue disorders | Skin and subcutaneous tissue disorders | DAIDS | Systematic Assessment |
|
| Psychiatric disorders | Psychiatric disorders | DAIDS | Systematic Assessment |
|
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | DAIDS | Systematic Assessment |
|
| Cardiovascular disorders | Cardiac disorders | DAIDS | Systematic Assessment |
|
| Musculoskelatal disorders | Musculoskeletal and connective tissue disorders | DAIDS | Systematic Assessment |
|
| Respiratory, thoracic, and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | DAIDS | Systematic Assessment |
|
| Genitourinary disorders | Renal and urinary disorders | DAIDS | Systematic Assessment |
|
| Infections and infestations | Infections and infestations | DAIDS | Systematic Assessment |
|
| Nervous system disorders | Nervous system disorders | DAIDS | Systematic Assessment |
|
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| 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 |
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |