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The study is designed as a retrospective data review of medical records from participants selected from specialist secondary and tertiary care centers across the United Kingdom (UK), specializing in Hepatitis C treatment. The study is non-interventional and is designed to identify subgroups of Hepatitis C Virus (HCV) genotype 1 participants in the 'real world', including the relation between subgroup characteristics and treatment responsiveness.
Physicians will record information (from the time of first exposure to pegylated interferon alfa-2b and ribavirin) from the medical notes of participants who fit the inclusion criteria. To prevent selection bias, data are to be taken from the latest consecutive, unique participants seen by the physician over the previous 48 months. This provides a method of random sampling from a physician practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with genotype 1 Hepatitis C Virus infection. | Participants with genotype 1 Hepatitis C Virus (HCV) infection who have been treated with pegylated interferon alfa-2b and ribavirin in the preceding 48 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alfa-2b (SCH 54031) | Biological | Peginterferon alfa-2b plus ribavirin will be administered according to the products' labeling. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Treatment Success | Identify subgroups of genotype 1 participants to better understand factors affecting response rates & treatment outcomes & to provide predictive models of refractory or responsive phenotypes to aid in HCV treatment, management, & drug development. Treatment success is defined as those who had achieved sustained virological response (i.e. undetectable viraemia 24 weeks post therapy completion). | Data will be collected from the start of first exposure to pegylated interferon alfa-2b and ribavirin combination therapy. Participants who have successfully completed treatment will have data collected for a follow-up period of at least 24 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with genotype 1 HCV infection who have been treated with pegylated interferon alfa-2b and ribavirin in the preceding 48 months at sites in the UK.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Genotype 1 Hepatitis C Virus Infection. | Participants with genotype 1 Hepatitis C Virus (HCV) infection who have been treated with pegylated interferon alfa-2b and ribavirin in the preceding 48 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Genotype 1 Hepatitis C Virus Infection. | Participants with genotype 1 Hepatitis C Virus (HCV) infection who have been treated with pegylated interferon alfa-2b and ribavirin in the preceding 48 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean age was calculated for 441 of the 442 participants. Age was missing for one participant. |
| 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 | Participants With Treatment Success | Identify subgroups of genotype 1 participants to better understand factors affecting response rates & treatment outcomes & to provide predictive models of refractory or responsive phenotypes to aid in HCV treatment, management, & drug development. Treatment success is defined as those who had achieved sustained virological response (i.e. undetectable viraemia 24 weeks post therapy completion). | Number of participants who had treatment success. | Posted | Number | Participants | Data will be collected from the start of first exposure to pegylated interferon alfa-2b and ribavirin combination therapy. Participants who have successfully completed treatment will have data collected for a follow-up period of at least 24 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 | Pegylated Interferon Alfa-2b and Ribavirin |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 12.1 | 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 (SCH 18908) | Drug | Peginterferon alfa-2b plus ribavirin will be administered according to the products' labeling. |
|
|
| Non-compliance |
|
| HCV RNA negative after 4 weeks |
|
| Participant moved away |
|
| Responder at 12 weeks, PCR + at 24 weeks |
|
| Only to have 24 week regimen |
|
| Viral Relapse |
|
| Acute HCV infection |
|
| Drug Relapse |
|
| Tolerability |
|
| Mean |
| Standard Deviation |
| Years |
|
| Sex/Gender, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 17 |
| 442 |
| 0 |
| 442 |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| ANGINA PECTORIS | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| HYPOTHYROIDISM | Endocrine disorders | MedDRA 12.1 | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| GASTRITIS | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| OESOPHAGEAL VARICES HAEMORRHAGE | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| SARCOIDOSIS | Immune system disorders | MedDRA 12.1 | Systematic Assessment |
|
| PNEUMONIA PNEUMOCOCCAL | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| SYNCOPE | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| ACUTE PSYCHOSIS | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| ANXIETY | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| HALLUCINATION | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| PARANOIA | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| SUICIDAL IDEATION | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| SUICIDE ATTEMPT | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
All data will be the property of the Sponsor. Although under no obligation, it is asked that the investigator discuss any publication with the sponsor prior to release and obtain written consent. The sponsor recognises the right of the investigator to publish the results upon study completion. However, it is asked that the investigator send a draft to the sponsor 30 days in advance of submission in order to obtain approval.
| 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 |