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This open-label, non-randomized, single arm study will provide treatment or re-treatment with Pegasys (peginterferon alfa-2a) as monotherapy or in combination with Copegus (ribavirin) to patients with chronic hepatitis C infection. Patients who have received prior Pegasys monotherapy or combination therapy or who were considered eligible for treatment with Pegasys in previous donor protocols will be eligible to participate in this study. Treatment will be on investigator's decision according to the approved label for up to 48 weeks, with a 24-week safety follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peginterferon alfa-2a monotherapy or combined with ribavirin | Experimental | The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alfa-2a | Drug | Both combination and monotherapy for both genotype 2/3 and genotype non-2/3: 180 μg subcutaneously once weekly. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least 1 Adverse Event | From Baseline to the end of the study (up to 72 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35295-0005 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Peginterferon Alfa-2a Monotherapy or Combined With Ribavirin | The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Ribavirin | Drug | For genotype 2/3, 800 mg orally daily, in 2 split doses for 24 weeks. For genotype non-2/3, 1000 mg orally daily for participants weighing < 75 kg or 1200 mg orally daily for participants weighing ≥ 75 kg, in 2 split doses, for 48 weeks. |
|
|
| La Jolla |
| California |
| 92037-1030 |
| United States |
| Long Beach | California | 90822 | United States |
| San Diego | California | 92123 | United States |
| San Diego | California | 92154 | United States |
| San Francisco | California | 94115 | United States |
| Aurora | Colorado | 80045 | United States |
| Gainesville | Florida | 32610-0214 | United States |
| Gainesville | Florida | 32610 | United States |
| Jacksonville | Florida | 32209 | United States |
| Miami | Florida | 33136-1051 | United States |
| Orlando | Florida | 32803 | United States |
| Orlando | Florida | 32809 | United States |
| Sarasota | Florida | 34243 | United States |
| Wellington | Florida | 33414 | United States |
| Atlanta | Georgia | 30308 | United States |
| Atlanta | Georgia | 30309 | United States |
| Marietta | Georgia | 30060 | United States |
| Honolulu | Hawaii | 96817 | United States |
| Boise | Idaho | 83702 | United States |
| Indianapolis | Indiana | 46202 | United States |
| Iowa City | Iowa | 52242 | United States |
| Kansas City | Kansas | 66160 | United States |
| Baltimore | Maryland | 21205 | United States |
| Framingham | Massachusetts | 01702 | United States |
| Worcester | Massachusetts | 01655 | United States |
| Plymouth | Minnesota | 55446 | United States |
| Newark | New Jersey | 07102 | United States |
| Vineland | New Jersey | 08360 | United States |
| Binghamton | New York | 13903 | United States |
| Manhasset | New York | 11030 | United States |
| New York | New York | 10016 | United States |
| New York | New York | 10021 | United States |
| Poughkeepsie | New York | 12601 | United States |
| Durham | North Carolina | 27710 | United States |
| Statesville | North Carolina | 28677 | United States |
| Cleveland | Ohio | 44106 | United States |
| Portland | Oregon | 97201 | United States |
| Lancaster | Pennsylvania | 17604-3200 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| Providence | Rhode Island | 02905 | United States |
| Germantown | Tennessee | 38138 | United States |
| Dallas | Texas | 75203 | United States |
| Houston | Texas | 77030 | United States |
| San Antonio | Texas | 78215 | United States |
| Charlottesville | Virginia | 22906-0013 | United States |
| Bellevue | Washington | 98004 | United States |
| Seattle | Washington | 98133 | United States |
| Tacoma | Washington | 98403 | United States |
| Adelaide | 5000 | Australia |
| Herston | 4006 | Australia |
| Ribeirão Preto | 14049-900 | Brazil |
| Salvador | 40150-130 | Brazil |
| São Paulo | 01246-000 | Brazil |
| São Paulo | 1323020 | Brazil |
| Vandœuvre-lès-Nancy | 54511 | France |
| Thessaloniki | 56429 | Greece |
| Bergamo | 24128 | Italy |
| Naples | 80131 | Italy |
| Warsaw | 01-201 | Poland |
| Ponce | 00716 | Puerto Rico |
| San Juan | 00921-3200 | Puerto Rico |
| San Juan | 00936-5067 | Puerto Rico |
| Santurce | 00909 | Puerto Rico |
| Barcelona | 08803 | Spain |
| Taoyuan | 333 | Taiwan |
| Plymouth | PL6 8DH | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Peginterferon Alfa-2a Monotherapy or Combined With Ribavirin | The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
| |||||||||||||||||||||||
| Height | Mean | Standard Deviation | Centimeters (cm) |
| ||||||||||||||||||||||
| Weight | Mean | Standard Deviation | Kilograms (kg) |
| ||||||||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| 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 | Percentage of Participants With at Least 1 Adverse Event | All participants analysis set. | Posted | Number | Percentage of participants | From Baseline to the end of the study (up to 72 weeks) |
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All participants analysis set.
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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 | Peginterferon Alfa-2a Monotherapy or Combined With Ribavirin | The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy. | 17 | 272 | 39 | 272 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Angina pectoris | Cardiac disorders | Systematic Assessment |
| ||
| Palpitations | Cardiac disorders | Systematic Assessment |
| ||
| Amaurosis fugax | Eye disorders | Systematic Assessment |
| ||
| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Cholelithiasis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Systematic Assessment |
| ||
| Cryptosporidiosis infection | Infections and infestations | Systematic Assessment |
| ||
| Gastroenteritis | Infections and infestations | Systematic Assessment |
| ||
| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Gun shot wound | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Toxicity to various agents | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Antibiotic resistant Staphylococcus test positive | Investigations | Systematic Assessment |
| ||
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Loss of consciousness | Nervous system disorders | Systematic Assessment |
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| Pregnancy | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Renal failure acute | Renal and urinary disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
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The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| 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 |
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| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| Oriental |
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| Other |
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