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This retrospective, observational study will assess the real world treatment out comes in the management of patients with chronic hepatitis C. No prospective ass essment or procedure with patients during this study will be conducted. Data wil l be collected from patient medical records of the year 2000-2011.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cohort |
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| Measure | Description | Time Frame |
|---|---|---|
| Sustained Virological Response (SVR): Percentage of Participants Who Were HCV Seronegative at 6 Months After Completing Therapy | SVR was defined a negative result upon polymerase chain reaction (PCR) ribonucleic acid (RNA) diagnostic testing after 6 months of treatment. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Were HCV Seronegative at the End of Treatment | End-of-treatment response (ETR) was defined as a negative result upon PCR RNA diagnostic testing at the end of treatment. | End of Study, up to 36 months after diagnosis. |
| Percentage of Participants With HCV Relapse (Biochemical or Virological) After Treatment Completion |
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Inclusion Criteria:
Exclusion Criteria:
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Retrospective survey of medical records of patients with chronic hepatitis C
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Vajira Hospital; Division of Gastroenterology and Hepatology | Bangkok | 10300 | Thailand |
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-Cirrhotic Chronic Hepatitis C (CHC) Observation Only | Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months. |
| FG001 | Hepatitis C Virus (HCV) - Related Cirrhosis Observation Only | Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-Cirrhotic CHC Observation Only | Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months. |
| BG001 | HCV - Related Cirrhosis Observation Only |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Sustained Virological Response (SVR): Percentage of Participants Who Were HCV Seronegative at 6 Months After Completing Therapy | SVR was defined a negative result upon polymerase chain reaction (PCR) ribonucleic acid (RNA) diagnostic testing after 6 months of treatment. | All enrolled participants. | Posted | Number | percentage of participants | 6 months |
|
Adverse events (AEs) were recorded from the begininng of treatment through the end of the study, approximately 36 months. This was a retrospective analysis study; safety reporting was generated spontaneously by physician discretion.
All participants for whom safety data was collected are included in the safety analysis. Systematic collection of safety data was not mandatory according to the protocol.
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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 | All Participants | Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC or HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffman-LaRoche | 800-821-8590 | genentech@druginfo.com |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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HCV relapse was determined by PCR RNA diagnostic testing. Virological relapse was defined as subsequent reappearance of serum HCV RNA after completion of therapy in participants who achieved end of treatment virological response (undetectable HCV RNA). Biochemical relapse was defined as subsequent rise in serum alanine aminotransferase (ALT) level after end of treatment with normal ALT. |
| End of Study, up to 36 months after diagnosis. |
| Percentage of Participants Who Progressed From CHC to Cirrhosis | Diagnosis and End of Study, up to 36 months after diagnosis. |
| Percentage of Participants Who Progressed From CHC to Hepatocellular Carcinoma (HCC) | Diagnosis and End of Study, up to 36 months after diagnosis. |
| Percentage of Participants Who Died | Any cause of death (including non-liver disease related) was reported. | Diagnosis and End of Study, up to 36 months after diagnosis |
| Other |
|
Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months. |
|
|
| Secondary | Percentage of Participants Who Were HCV Seronegative at the End of Treatment | End-of-treatment response (ETR) was defined as a negative result upon PCR RNA diagnostic testing at the end of treatment. | All enrolled participants | Posted | Number | percentage of participants | End of Study, up to 36 months after diagnosis. |
|
|
|
| Secondary | Percentage of Participants With HCV Relapse (Biochemical or Virological) After Treatment Completion | HCV relapse was determined by PCR RNA diagnostic testing. Virological relapse was defined as subsequent reappearance of serum HCV RNA after completion of therapy in participants who achieved end of treatment virological response (undetectable HCV RNA). Biochemical relapse was defined as subsequent rise in serum alanine aminotransferase (ALT) level after end of treatment with normal ALT. | All enrolled participants; | Posted | Number | percentage of participants | End of Study, up to 36 months after diagnosis. |
|
|
|
| Secondary | Percentage of Participants Who Progressed From CHC to Cirrhosis | All enrolled participants | Posted | Number | percentage of participants | Diagnosis and End of Study, up to 36 months after diagnosis. |
|
|
|
|
| Secondary | Percentage of Participants Who Progressed From CHC to Hepatocellular Carcinoma (HCC) | All enrolled participants | Posted | Number | percentage of participants | Diagnosis and End of Study, up to 36 months after diagnosis. |
|
|
|
|
| Secondary | Percentage of Participants Who Died | Any cause of death (including non-liver disease related) was reported. | All enrolled participants | Posted | Number | percentage of participants | Diagnosis and End of Study, up to 36 months after diagnosis |
|
|
|
| 0 |
| 47 |
| 4 |
| 47 |
| Leucopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Intracranial hemorrhage | Vascular disorders | Non-systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | Non-systematic Assessment |
|
| Severe anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
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.
| 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 |