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To study retreatment in patients who failed prior treatment with interferon alpha (pegylated or non-pegylated) with or without ribavirin in a real-life setting in an observational/noninterventional study.
This is an observational/non interventional study to collect data on the patient characteristics of those seeking retreatment as well as safety and efficacy information during the first 12 weeks of retreatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peginterferon alpha and ribavirin | Peginterferon alpha and ribavirin will be administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alpha | Biological | Peginterferon alpha given in combination with ribavirin according to local labeling guidelines |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Serious Adverse Events (SAEs) and/or Clinically Significant Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant administered a medicinal product which did not necessarily have a causal relationship to the treatment. All AEs reported in the study were judged by the investigator to be clinically significant. An SAE was any adverse drug experience that resulted in death, was life-threatening, caused or prolonged hospitalization, caused persistent or significant disability or incapacity, caused a congenital anomaly or birth defect, or may have required medical or surgical intervention to prevent one of these outcomes. | Up to 12 Weeks |
| Incidence of Thrombocytopenia | Thrombocytopenia is a low blood platelet count | Up to 12 Weeks |
| Incidence of Treatment Discontinuations Due to Adverse Events | All treatment discontinuations due to an AE were reported. See Outcome Measure 1 for definition of AEs. | Up to 12 Weeks |
| Incidence of Particular Adverse Events Resulting in Treatment Discontinuation | All treatment discontinuations due to particular AEs were reported. These discontinuations included treatment stopped (TS) and dose reduced followed by treatment stopped (DR/TS). The particular AE evaluated were anemia (low red blood cells), leucopenia (low white blood cells), neutropenia (low blood neutrophils), thrombocytopenia (low blood platelets), esophageal varices (dilated veins in lower esophagus), splenomegaly (enlarged spleen), portal hypertensive gastropathy (changes in stomach mucosa), and hepatomegaly (enlarged liver) | Up to 12 Weeks |
| Incidence of Dose Modifications Due to Adverse Events | All dose modifications due to an AE were reported. See Outcome Measure 1 for definition of AEs. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Who Achieve Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA) | Participant's blood was tested for HCV-RNA by quantitative polymerase chain reaction. The limit of detection for the assay was 50 IU/mL. | Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who failed prior treatment with interferon alpha (pegylated or non-pegylated) with or without ribavirin
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First participant enrolled: 9 February 2009; last participant completed: 17 October 2011. The study was conducted in 117 centers in 12 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Peginterferon Alpha and Ribavirin | Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Peginterferon Alpha and Ribavirin | Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries. |
| 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 | Incidence of Serious Adverse Events (SAEs) and/or Clinically Significant Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant administered a medicinal product which did not necessarily have a causal relationship to the treatment. All AEs reported in the study were judged by the investigator to be clinically significant. An SAE was any adverse drug experience that resulted in death, was life-threatening, caused or prolonged hospitalization, caused persistent or significant disability or incapacity, caused a congenital anomaly or birth defect, or may have required medical or surgical intervention to prevent one of these outcomes. | Posted | Number | percentage of participants | Up to 12 Weeks |
|
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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 Alpha and Ribavirin | Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C417083 | peginterferon alfa-2b |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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|
| Ribavirin | Drug | Ribavirin given in combination with peginterferon alpha according to local labeling guidelines |
|
|
| Up to 12 Weeks |
| No reason reported |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Previous non-response type | Participants in the study previously failed to respond with a sustained virologic response to treatment with interferon alpha with or without ribavirin. The type of previous non-response was categorized at study baseline. | Number | participants |
|
|
|
| Primary | Incidence of Thrombocytopenia | Thrombocytopenia is a low blood platelet count | Posted | Number | percentage of participants | Up to 12 Weeks |
|
|
|
| Primary | Incidence of Treatment Discontinuations Due to Adverse Events | All treatment discontinuations due to an AE were reported. See Outcome Measure 1 for definition of AEs. | Posted | Number | percentage of participants | Up to 12 Weeks |
|
|
|
| Primary | Incidence of Particular Adverse Events Resulting in Treatment Discontinuation | All treatment discontinuations due to particular AEs were reported. These discontinuations included treatment stopped (TS) and dose reduced followed by treatment stopped (DR/TS). The particular AE evaluated were anemia (low red blood cells), leucopenia (low white blood cells), neutropenia (low blood neutrophils), thrombocytopenia (low blood platelets), esophageal varices (dilated veins in lower esophagus), splenomegaly (enlarged spleen), portal hypertensive gastropathy (changes in stomach mucosa), and hepatomegaly (enlarged liver) | Posted | Number | percentage of participants | Up to 12 Weeks |
|
|
|
| Primary | Incidence of Dose Modifications Due to Adverse Events | All dose modifications due to an AE were reported. See Outcome Measure 1 for definition of AEs. | Posted | Number | percentage of participants | Up to 12 Weeks |
|
|
|
| Secondary | Proportion of Participants Who Achieve Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA) | Participant's blood was tested for HCV-RNA by quantitative polymerase chain reaction. The limit of detection for the assay was 50 IU/mL. | The population analyzed was 920 participants who received at least 1 dose of study drug and had data collected at the Week 12 visit | Posted | Number | 95% Confidence Interval | percentage of participants | Week 12 |
|
|
|
| 18 |
| 963 |
| 211 |
| 963 |
| Leucopenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Acute tonsillitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Campylobacter infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Parkinson's disease | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
|
| Metrorrhagia | Reproductive system and breast disorders | MedDRA 14.1 | Systematic Assessment |
|
| Leucopenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 14.1 | Systematic Assessment |
|
The investigator agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial. The sponsor shall have the right to review and comment with respect to publications, abstracts, slides, and manuscripts. Investigator agrees to meet with sponsor's representatives prior to submission for publication to discuss and resolve any disagreements.
| 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 |
| Title | Measurements |
|---|---|
|
| TS - Thrombocytopenia |
|
| TS - Esophageal varices |
|
| TS - Splenomegaly |
|
| TS -Portal hypertensive gastropathy |
|
| TS - Hepatomegaly |
|
| DR/TS - Anemia |
|
| DR/TS - Leucopenia |
|
| DR/TS - Neutropenia |
|
| DR/TS - Thrombocytopenia |
|
| DR/TS - Esophageal varices |
|
| DR/TS - Splenomegaly |
|
| DR/TS - Portal hypertensive gastropathy |
|
| DR/TS - Hepatomegaly |
|
| Title |
|---|
| Measurements |
|---|
|