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The goal of this study is to elucidate the reasons why patients with chronic hepatitis C (CHC) would not be considered eligible for antiviral treatment. The study is conducted in common clinical practice at approximately 54 sites in Italy. Patients deemed eligible for antiviral therapy will be treated at the discretion of the physician with either peginterferon alfa-2a or peginterferon alfa-2b, both in combination with ribavirin, in accordance with approved labeling. A secondary objective of this study is to define "treatment failure" and to evaluate the reasons for treatment discontinuation.
Probability sampling: Consecutive adult patients with chronic hepatitis C in clinical practice at approximately 54 sites in Italy will be included in the study. The decision as to treatment choice falls at the discretion of the treating physician.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Chronic Hepatitis C (CHC) | Peginterferon-naïve participants with CHC seen in general clinical practice in Italy and treated with either pegylated interferon alfa-2a or alfa-2b + ribavirin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alfa-2b | Biological | Peginterferon alfa-2b administered in accordance with approved labeling |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility | Investigators recorded their reasons for not prescribing anti-viral treatment. More than one reason leading to non-eligibility could be presented for the same participant. | Measured at baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Discontinued From Treatment by Reason for Discontinuation | Investigators recorded reasons for treatment discontinuation. | 24 weeks after the end of treatment (total of 48 to 72 weeks) |
| Number of Participants With Treatment Failure by Reason for Failure |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive adult patients with chronic hepatitis C seen in common clinical practice at approximately 54 sites in Italy. Treatment for hepatitis C is determined at the local site (pegylated interferon a or b/ribavirin).
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25483909 | Derived | Vukotic R, Gamal N, Andreone P. Prospective, observational real-life study on eligibility for and outcomes of antiviral treatment with peginterferon alpha plus ribavirin in chronic hepatitis C. Dig Liver Dis. 2015 Feb;47(2):151-6. doi: 10.1016/j.dld.2014.11.002. Epub 2014 Nov 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Chronic Hepatitis C (CHC) | Peginterferon-naïve participants with chronic hepatitis C (CHC) seen in general clinical practice in Italy. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Chronic Hepatitis C (CHC) | Peginterferon-naïve participants with CHC seen in general clinical practice in Italy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility | Investigators recorded their reasons for not prescribing anti-viral treatment. More than one reason leading to non-eligibility could be presented for the same participant. | 431 of the 1118 participants were determined to be non-eligible for antiviral therapy by Investigator decision. | Posted | Number | participants | Measured at baseline |
|
|
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500 participants on this study were treated with either PegInterferon alfa-2a or alfa-2b/+ ribavirin per facility guidelines but treatment drugs were not recorded for this study. Adverse events (AEs) were collected for participants treated with any Sponsor product, but not with other company products; therefore, the AEs are disclosed at 0% level.
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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 | Participants With Chronic Hepatitis C (CHC) | Peginterferon-naïve participants with CHC seen in general clinical practice in Italy. |
| 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 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C417083 | peginterferon alfa-2b |
| D012254 | Ribavirin |
| C100416 | peginterferon alfa-2a |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| Ribavirin | Drug | Ribavirin administered in accordance with approved labeling |
|
|
| Peginterferon alfa-2a | Biological | Peginterferon alfa-2a administered in accordance with approved labeling |
|
|
Investigators recorded reasons for treatment failure whether or not treatment was completed. |
| 24 to 48 weeks |
| Participant Refused Treatment |
|
| Never Started Treatment |
|
| Unknown; No Data Sources Available |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| Investigator + Participant Decision |
|
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Number of Participants Discontinued From Treatment by Reason for Discontinuation | Investigators recorded reasons for treatment discontinuation. | Reasons for treatment discontinuations were recorded by Investigators for 174 of the 500 treated participants. | Posted | Number | participants | 24 weeks after the end of treatment (total of 48 to 72 weeks) |
|
|
|
| Secondary | Number of Participants With Treatment Failure by Reason for Failure | Investigators recorded reasons for treatment failure whether or not treatment was completed. | 132 of the 500 treated participants failed treatment per Investigator assessment. | Posted | Number | participants | 24 to 48 weeks |
|
|
|
| 6 |
| 500 |
| 169 |
| 500 |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (13.1) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (13.1) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (13.1) | Systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Systematic Assessment |
|
| Non-hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
|
| Hemiplegia | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
|
| Polyneuropathy | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA (13.1) | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA (13.1) | Systematic Assessment |
|
| Haemoglobinaemia | Blood and lymphatic system disorders | MedDRA (13.1) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (13.1) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (13.1) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (13.1) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (13.1) | Systematic Assessment |
|
| Deafness | Ear and labyrinth disorders | MedDRA (13.1) | Systematic Assessment |
|
| Autoimmune thyroiditis | Endocrine disorders | MedDRA (13.1) | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA (13.1) | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA (13.1) | Systematic Assessment |
|
| Chalazion | Eye disorders | MedDRA (13.1) | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA (13.1) | Systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA (13.1) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Aerophagia | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Gingivitis | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (13.1) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (13.1) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (13.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (13.1) | Systematic Assessment |
|
| Hyperpyrexia | General disorders | MedDRA (13.1) | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (13.1) | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA (13.1) | Systematic Assessment |
|
| Irritability | General disorders | MedDRA (13.1) | Systematic Assessment |
|
| Malaise | General disorders | MedDRA (13.1) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (13.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (13.1) | Systematic Assessment |
|
| Gallbladder disorder | Hepatobiliary disorders | MedDRA (13.1) | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
| Blood thyroid stimulating hormone increased | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| Serum ferritin increased | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| Thyroid function test abnormal | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (13.1) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (13.1) | Systematic Assessment |
|
| Insulin resistance | Metabolism and nutrition disorders | MedDRA (13.1) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| Dementia | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
|
| Polyneuropathy | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA (13.1) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (13.1) | Systematic Assessment |
|
| Apathy | Psychiatric disorders | MedDRA (13.1) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (13.1) | Systematic Assessment |
|
| Generalised anxiety disorder | Psychiatric disorders | MedDRA (13.1) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (13.1) | Systematic Assessment |
|
| Mood altered | Psychiatric disorders | MedDRA (13.1) | Systematic Assessment |
|
| Nervousness | Psychiatric disorders | MedDRA (13.1) | Systematic Assessment |
|
| Panic attack | Psychiatric disorders | MedDRA (13.1) | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (13.1) | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA (13.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Dyspoenia | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| Trichorrhexis | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| Vitiligo | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (13.1) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (13.1) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (13.1) | Systematic Assessment |
|
The principal investigator agrees not to publish or publicly present any interim results of the Study without prior written consent of the sponsor. The principal investigator further agrees to provide 45 days written notice to the sponsor prior to submission for publication or presentation to permit the sponsor to review copies of abstracts or manuscripts for publication.
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006521 | Hepatitis, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| Adverse effect |
|
| Administrative reason |
|
| Virological response |
|
| Other reasons |
|