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| ID | Type | Description | Link |
|---|---|---|---|
| BR 002-07 |
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This is a Phase 4, retrospective and observational, multicenter, national (Brazil), open, noncomparative, and nonrandomized study, which does not have visits. This study will be conducted in accordance to Good Clinical Practices. The procedure will be the review of medical records of patients who have already completed 12 weeks of treatment of chronic hepatitis C with peginterferon alfa-2b and ribavirin. This review will take place after the subjects have signed the informed consent form authorizing collection of these data. The collection of data for virological response after Week 12 will be collected prospectively through the review of medical records after the subjects have completed their entire treatment and follow-up period.
This is a Phase 4, retrospective and observational, multicenter, national (Brazil), open, noncomparative, and nonrandomized study, which does not have visits. This study will be conducted in accordance to Good Clinical Practices. The procedure will be the review of medical records of patients who have already completed 12 weeks of treatment of chronic hepatitis C with peginterferon alfa-2b and ribavirin. This review will take place after the subjects have signed the informed consent form authorizing collection of these data. The physician will be filling out the case report form with the information contained in the medical record. Any dose reduction and/or doses not taken during this period will be reported through the case report form. The collection of data for virological response after Week 12 (such as virological response at the end of treatment and sustained virological response after follow-up period) will be collected prospectively through the review of medical records after the subjects have completed their entire treatment and follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Naïve patients | Patients, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had not been treated with peginterferon alfa-2b. |
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| Group 2: Re-treatment | Patients, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had been considered nonresponders or relapsing to prior treatment for chronic hepatitis C. |
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| Group 3: HIV/HCV co-infected patients | Patients, from Brazil, with confirmed chronic hepatitis C and infected with Humman Immunodeficiency Virus (HIV) who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alfa-2b | Biological | PegIntron 80 μg, PegIntron 100 μg, or PegIntron 120 μg. The duration of the complete treatment and the doses of pegylated interferon alfa 2b should have been prescribed according to local guidelines, and according to the investigating physician's orientation. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants Who Were Compliant to Treatment in the First 12 Weeks | The participant was considered compliant if he/she had administered 80% of the doses of pegylated interferon alpha 2b and 80% of the doses of ribavirin that were prescribed by the physician in the first 12 weeks of treatment. | First 12 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants Who Achieved Rapid Virologic Response (RVR) | RVR was defined as HCV RNA negative after 4 weeks of treatment. | Week 4 |
| Percent of Participants Who Achieved Early Virologic Response (EVR) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin. Patients will come from approximately 65 Brazilian sites and should satisfy all inclusion criteria and none of the exclusion criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | General Peginterferon + Ribavarin | Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | General Peginterferon + Ribavarin | Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age data were only available for 900 participants |
| 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 | Percent of Participants Who Were Compliant to Treatment in the First 12 Weeks | The participant was considered compliant if he/she had administered 80% of the doses of pegylated interferon alpha 2b and 80% of the doses of ribavirin that were prescribed by the physician in the first 12 weeks of treatment. | All enrolled participants | Posted | Number | 95% Confidence Interval | Percent of participants | First 12 weeks of treatment |
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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 | General Peginterferon + Ribavarin | Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClincialTrialsDisclosure@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 250 mg. The duration of the complete treatment and the doses of ribavirin should have been prescribed according to local guidelines, and according to the investigating physician's orientation. |
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EVR was defined as HCV RNA negative after 12 weeks of treatment.
| Week 12 |
| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Re-treatment | Participants, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had been considered nonresponders or relapsing to prior treatment for chronic hepatitis C. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation. |
| OG002 | HIV/Hepatitis C Virus (HCV) Co-infected Participants | Participants, from Brazil, with confirmed chronic hepatitis C and infected with human immunodeficiency virus (HIV) who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation. |
|
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| Secondary | Percent of Participants Who Achieved Rapid Virologic Response (RVR) | RVR was defined as HCV RNA negative after 4 weeks of treatment. | Number of participants with data | Posted | Number | 95% Confidence Interval | Percent of participants | Week 4 |
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|
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| Secondary | Percent of Participants Who Achieved Early Virologic Response (EVR) | EVR was defined as HCV RNA negative after 12 weeks of treatment. | Number of participants with data | Posted | Number | 95% Confidence Interval | Percent of participants | Week 12 |
|
|
|
| 11 |
| 902 |
| 658 |
| 902 |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
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| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
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| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| GASTROENTERITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| ASTHENIA | General disorders | MedDRA 13.1 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 13.1 | Systematic Assessment |
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| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 13.1 | Systematic Assessment |
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| IRRITABILITY | General disorders | MedDRA 13.1 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 13.1 | Systematic Assessment |
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| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
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| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
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The text of the article that will be submitted to the journal shall be defined in common accord between the Investigators and the Sponsor. The principal investigators also agree to not publish and/or present interim results of the study without due written authorization of the Sponsor.
| 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 |