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This 2-arm study was designed to evaluate the efficacy, safety, and tolerability of prophylactic PEGASYS plus COPEGUS after liver transplantation for hepatitis C, compared to initiation of antiviral therapy at the time of clinical recurrence of hepatitis C infection. The anticipated time on study treatment was 3-12 months, and the target sample size was 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| peginterferon alfa-2a [Pegasys] | Drug | 135 micrograms subcutaneously (SC) weekly for 4 weeks followed by 180 micrograms SC weekly for 44 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Histologically-confirmed Recurrence of Hepatitis C Virus (HCV) | Histologically-confirmed recurrence of HCV defined as Batts-Ludwig inflammation grade ≥3 and/or fibrosis stage ≥2. Inflammation(Grade): 0 No Activity,1 Minimal,2 Mild,3 Moderate,4 Severe. Fibrosis (Stage): 0 No fibrosis, Normal; 1 Portal fibrosis; 2 Periportal fibrosis or rare portal septa; 3 Septal fibrosis, Fibrous septa with architectural distortion, no obvious cirrhosis; 4 Cirrhosis. | 120 weeks postrandomization |
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Virologic Response | Rapid virologic responder (RVR): undetectable HCV-RNA at Week 4; complete early virologic responder (cEVR): undetectable HCV-RNA at Week 12; partial early virologic responder (pEVR): ≥2 log10 drop from baseline in HCV-RNA but positive at Week 12; early virologic responder (EVR): undetectable HCV-RNA or ≥2 log10 drop from baseline in HCV-RNA at Week 12; 24 weeks negative: undetectable HCV-RNA at Week 24; 48 weeks negative: undetectable HCV-RNA at Week 48; sustained virologic response (SVR): undetectable HCV-RNA at 24 weeks after the end of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35294 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21506241 | Derived | Bzowej N, Nelson DR, Terrault NA, Everson GT, Teng LL, Prabhakar A, Charlton MR; PHOENIX Study Group. PHOENIX: A randomized controlled trial of peginterferon alfa-2a plus ribavirin as a prophylactic treatment after liver transplantation for hepatitis C virus. Liver Transpl. 2011 May;17(5):528-38. doi: 10.1002/lt.22271. |
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Eligible for the study were male or female patients ≥18 years of age with HCV infection who underwent orthotopic liver transplantation (OLT) because of liver cirrhosis attributed to HCV infection
Patients were recruited from 24 study centers in the US over a period of 4 years (12-Oct-04 - 17-Oct-08)
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| ID | Title | Description |
|---|---|---|
| FG000 | Prophylaxis Arm | Pegylated interferon alfa-2a subcutaneously (SC) 135 μg/week for 4 weeks, then increased to 180 μg/week for the next 44 weeks, plus Ribavirin orally 400 mg/day (initial) to 1000 mg/day for patients <75 kg or 1200 mg/day for patients ≥75 kg PO (escalated) (maximum) administered orally |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Copegus | Drug | 400 mg orally (PO) daily escalating to 1200 mg PO daily, for 48 weeks |
|
| After 4, 12, 24 and 48 weeks of therapy, and 24 weeks of follow-up |
| Phoenix |
| Arizona |
| 85054 |
| United States |
| Los Angeles | California | 90095-1749 | United States |
| San Francisco | California | 94115 | United States |
| San Francisco | California | 94143 | United States |
| Aurora | Colorado | 80045 | United States |
| Gainesville | Florida | 32610-0214 | United States |
| Jacksonville | Florida | 32216 | United States |
| Miami | Florida | 33136-1051 | United States |
| Chicago | Illinois | 60611 | United States |
| Indianapolis | Indiana | 46202 | United States |
| Baltimore | Maryland | 21205 | United States |
| Burlington | Massachusetts | 01805 | United States |
| Minneapolis | Minnesota | 55455 | United States |
| Rochester | Minnesota | 55905 | United States |
| St Louis | Missouri | 63110 | United States |
| Omaha | Nebraska | 68198-3285 | United States |
| Newark | New Jersey | 07101-1709 | United States |
| New York | New York | 10016 | United States |
| New York | New York | 10029 | United States |
| Cincinnati | Ohio | 45267 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| Philadelphia | Pennsylvania | 19141 | United States |
| Nashville | Tennessee | 37232 | United States |
| Dallas | Texas | 75246 | United States |
| San Antonio | Texas | 78284 | United States |
| Seattle | Washington | 98195 | United States |
| Madison | Wisconsin | 53792 | United States |
| Observation Arm |
No antiviral therapy for HCV unless recurrence of HCV was histologically demonstrated. Once histological recurrence was demonstrated, patients received the same antiviral regimen as patients in the prophylaxis arm (ie, 48 weeks of combined PEG-IFN alfa-2a and ribavirin) |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Prophylaxis Arm | Pegylated interferon alfa-2a subcutaneously (SC) 135 μg/week for 4 weeks, then increased to 180 μg/week for the next 44 weeks, plus Ribavirin orally 400 mg/day (initial) to 1000 mg/day for patients <75 kg or 1200 mg/day for patients ≥75 kg PO (escalated) (maximum) administered orally |
| BG001 | Observation Arm | No antiviral therapy for HCV unless recurrence of HCV was histologically demonstrated. Once histological recurrence was demonstrated, patients received the same antiviral regimen as patients in the prophylaxis arm (ie, 48 weeks of combined PEG-IFN alfa-2a and ribavirin) |
| BG002 | 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| 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 | Percentage of Patients With Histologically-confirmed Recurrence of Hepatitis C Virus (HCV) | Histologically-confirmed recurrence of HCV defined as Batts-Ludwig inflammation grade ≥3 and/or fibrosis stage ≥2. Inflammation(Grade): 0 No Activity,1 Minimal,2 Mild,3 Moderate,4 Severe. Fibrosis (Stage): 0 No fibrosis, Normal; 1 Portal fibrosis; 2 Periportal fibrosis or rare portal septa; 3 Septal fibrosis, Fibrous septa with architectural distortion, no obvious cirrhosis; 4 Cirrhosis. | Intent-to-treat population | Posted | Number | percentage of participants | 120 weeks postrandomization |
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| Secondary | Summary of Virologic Response | Rapid virologic responder (RVR): undetectable HCV-RNA at Week 4; complete early virologic responder (cEVR): undetectable HCV-RNA at Week 12; partial early virologic responder (pEVR): ≥2 log10 drop from baseline in HCV-RNA but positive at Week 12; early virologic responder (EVR): undetectable HCV-RNA or ≥2 log10 drop from baseline in HCV-RNA at Week 12; 24 weeks negative: undetectable HCV-RNA at Week 24; 48 weeks negative: undetectable HCV-RNA at Week 48; sustained virologic response (SVR): undetectable HCV-RNA at 24 weeks after the end of treatment. | ITT population | Posted | Number | participants | After 4, 12, 24 and 48 weeks of therapy, and 24 weeks of follow-up |
|
Adverse Events were collected for the period of the study (4 years, 12-Oct-2004 - 17-Oct-2008)
Safety Population: 54 patients in the prophylaxis arm, and 60 patients in the observation arm. One patient randomized to the prophylaxis arm was excluded from the safety population because they withdrew consent before receiving any study medication and did not have any postbaseline assessments.
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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 | Prophylaxis Arm | Pegylated interferon alfa-2a subcutaneously (SC) 135 μg/week for 4 weeks, then increased to 180 μg/week for the next 44 weeks, plus Ribavirin orally 400 mg/day (initial) to 1000 mg/day for patients <75 kg or 1200 mg/day for patients ≥75 kg PO (escalated) (maximum) administered orally | 25 | 54 | 54 | 54 | ||
| EG001 | Observation Arm | No antiviral therapy for HCV unless recurrence of HCV was histologically demonstrated. Once histological recurrence was demonstrated, patients received the same antiviral regimen as patients in the prophylaxis arm (ie, 48 weeks of combined PEG-IFN alfa-2a and ribavirin) | 21 | 60 | 58 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infections and infestations | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Gastrointestinal disorders | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Hepatobiliary disorders | Hepatobiliary disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Blood and lymphatic system disordersimag | Blood and lymphatic system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Cardiac disorders | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Investigations | Investigations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Surgical and medical proceduresi | Surgical and medical procedures | MedDRA (11.0) | Non-systematic Assessment |
| |
| Endocrine disorders | Endocrine disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Immune system disorders | Immune system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Reproductive system and breast disorders | Reproductive system and breast disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| General disorders and administration site conditions | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Injury, poisoning and procedural complicationsE | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Nervous system disorders | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Renal and urinary disorders | Renal and urinary disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Neoplasms benign, malignant and unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Non-systematic Assessment |
| |
| Vascular disorders | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General Disorders and administration site conditions | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Gastrointestinal disorders | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Nervous system disorders | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Psychiatric disorders | Psychiatric disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Infections and infestations | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Investigations | Investigations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Renal and urinary disorders | Renal and urinary disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Vascular disorders | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Eye disorders | Eye disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Hepatobiliary disorders | Hepatobiliary disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Reproductive system and breast disorders | Reproductive system and breast disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Neoplasms benign, malignant and unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Non-systematic Assessment |
| |
| Surgical and medical procedures | Surgical and medical procedures | MedDRA (11.0) | Non-systematic Assessment |
| |
| Ear and labyrinth disorders | Ear and labyrinth disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Cardiac disorders | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Endocrine disorders | Endocrine disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Social circumstances | Social circumstances | MedDRA (11.0) | Non-systematic Assessment |
| |
| Immune system disorders | Immune system disorders | MedDRA (11.0) | Non-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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| Male |
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| Units | Counts |
|---|---|
| Participants |
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