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Study terminated due to the Sponsor's decision.
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This prospective, national, multicenter, non-interventional study examined the use of triple combination therapy with boceprevir, pegylated interferon (peginterferon) alfa-2a and ribavirin in re-treating participants with genotype 1 chronic hepatitis C (CHC) infection. Dosing and treatment duration were at the discretion of the investigator in accordance with local clinical practice and local labeling. Participants were to be observed for the duration of their triple combination therapy and for up to 24 weeks thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triple Combination Therapy | Participants who demonstrated genotype 1 chronic hepatitis C infection and had a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa + ribavirin, and who were subjected to receive a triple combination therapy with simeprevir or boceprevir plus peginterferon alfa-2a and ribavirin were observed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Boceprevir | Drug | Boceprevir administered according to corresponding summary of product characteristics (SmPC). |
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| Measure | Description | Time Frame |
|---|---|---|
| Sustained Virological Response 24 (SVR24) Rate | The SVR 24 rate is defined as percentage of participants with Hepatitis C virus (HCV) Ribonucleic Acid (RNA) less than 15 international unit/milliliter (IU/mL) after the 24-weeks follow-up. | 24 weeks after end of treatment (EOT) at Week 72 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Virological Response | Virological response is defined as HCV RNA <15 IU/mL. | Weeks 4, 8, 12, and 24 |
| Number of Participants With Virological Breakthrough | Virological breakthrough is defined as either HCV RNA >=15 IU/mL in participants with prior virological response or as an increase in HCV RNA >/=1 log10 above nadir. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with genotype 1 chronic hepatitis C (CHC) infection taking triple combination therapy (boceprevir, peginterferon alfa-2a and ribavirin)
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Békéscsaba | 5600 | Hungary | ||||
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A total of 19 participants were enrolled in 8 study centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Triple Combination Therapy | Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Blood serum used to analyze levels of hepatitic c virus (HCV) ribonucleic acid (RNA)
| Simeprevir | Drug | Simeprevir administered according to corresponding summary of product characteristics (SmPC). |
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| Pegylated Interferon (Peginterferon) Alfa-2a | Drug | Pegylated interferon (peginterferon) alfa-2a according to corresponding summary of product characteristics (SmPC). |
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| Ribavirin | Drug | Ribavirin according to corresponding summary of product characteristics (SmPC). |
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| Up to Week 48 |
| Number of Participants With Virological Relapse | Virological response is defined as HCV RNA >/=15 IU/mL during the treatment free follow-up period in participants with virological response at the end of treatment. | Week 49 up to Week 72 |
| Number of Participants With Treatment Discontinuation Due to Futility | Treatment discontinuation due to futility is defined as HCV RNA drop <3 log10 at Week 8, HCV RNA >/=100 IU/mL at Week 12, or HCV RNA >/=15 IU/mL at Week 24. | Up to Week 48 |
| Number of Participants With Treatment Discontinuation | Treatment discontinuation is reported by sub-categories of reasons for treatment discontinuation. Futility rule is defined as HCV RNA drop <3 log10 at Week 8, HCV RNA >/=100 IU/mL at Week 12, or HCV RNA >/=15 IU/mL at Week 24. | Up to Week 48 |
| Number of Participants With Adverse Events | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | Up to 72 weeks |
| Percentage of Participants With Positive Predictive Value of Participant Demographics for SVR Rate | Demographic characteristics recorded were age and gender. Predictive value of these characteristics for SVR rate was to be assessed. | Screening (before Week 1) |
| Percentage of Participants With Positive Predictive Value of Liver Fibrosis | The following sub-categories of liver fibrosis were determined in this study: 1) no cirrhosis, 2) bridging fibrosis and 3) cirrhosis. Predictive value of these sub-categories of liver fibrosis for SVR rate was to be assessed. | Screening (before Week 1) |
| Predictive Value of HCV Disease Characteristics | HCV disease characteristics evaluated were HCV genotype (subtype), including HCV 1(a) and HCV 1(b). Predictive value of these disease characteristics for SVR rate were to be assessed. | Screening (before Week 1) |
| Percentage of Participants With Positive Predictive Value of Previous Virological Response (Null-response, Partial Response, or Relapse) | Previous virological response was sub-categorized into the following categories: null-response, partial response, or relapse. Predictive value of these sub-categories for SVR rate were to be assessed. | Up to 72 weeks |
| Budapest |
| 1097 |
| Hungary |
| Budapest | 1125 | Hungary |
| Debrecen | 4032 | Hungary |
| Eger | 3300 | Hungary |
| Kaposvár | 7400 | Hungary |
| Szombathely | 8800 | Hungary |
| COMPLETED |
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| NOT COMPLETED |
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Analysis was performed on all enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Triple Combination Therapy | Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed. |
| 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 | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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 24 (SVR24) Rate | The SVR 24 rate is defined as percentage of participants with Hepatitis C virus (HCV) Ribonucleic Acid (RNA) less than 15 international unit/milliliter (IU/mL) after the 24-weeks follow-up. | Due to the early termination of the study follow-up of the vast majority of the participants was not possible and data were not collected. Therefore, results for this outcome measure are based on one participant. | Posted | Number | percentage of participants | 24 weeks after end of treatment (EOT) at Week 72 |
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| Secondary | Percentage of Participants With Virological Response | Virological response is defined as HCV RNA <15 IU/mL. | Intent to treat (ITT) population included all enrolled participants. Here, 'n' indicated number of participants with virological response data at evaluated time points. | Posted | Number | percentage of participants | Weeks 4, 8, 12, and 24 |
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| Secondary | Number of Participants With Virological Breakthrough | Virological breakthrough is defined as either HCV RNA >=15 IU/mL in participants with prior virological response or as an increase in HCV RNA >/=1 log10 above nadir. | ITT population included all enrolled participants. | Posted | Number | participants | Up to Week 48 |
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| Secondary | Number of Participants With Virological Relapse | Virological response is defined as HCV RNA >/=15 IU/mL during the treatment free follow-up period in participants with virological response at the end of treatment. | ITT population included all enrolled participants. | Posted | Number | participants | Week 49 up to Week 72 |
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| Secondary | Number of Participants With Treatment Discontinuation Due to Futility | Treatment discontinuation due to futility is defined as HCV RNA drop <3 log10 at Week 8, HCV RNA >/=100 IU/mL at Week 12, or HCV RNA >/=15 IU/mL at Week 24. | ITT population included all enrolled participants. | Posted | Number | participants | Up to Week 48 |
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| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Discontinuation | Treatment discontinuation is reported by sub-categories of reasons for treatment discontinuation. Futility rule is defined as HCV RNA drop <3 log10 at Week 8, HCV RNA >/=100 IU/mL at Week 12, or HCV RNA >/=15 IU/mL at Week 24. | ITT population included all enrolled participants. | Posted | Number | participants | Up to Week 48 |
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| Secondary | Number of Participants With Adverse Events | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | ITT population included all enrolled participants. | Posted | Number | participants | Up to 72 weeks |
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| Secondary | Percentage of Participants With Positive Predictive Value of Participant Demographics for SVR Rate | Demographic characteristics recorded were age and gender. Predictive value of these characteristics for SVR rate was to be assessed. | Predictive values of participant demographics could not be analyzed as the SVR24 rate was based on one participant. | Posted | Screening (before Week 1) |
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| Secondary | Percentage of Participants With Positive Predictive Value of Liver Fibrosis | The following sub-categories of liver fibrosis were determined in this study: 1) no cirrhosis, 2) bridging fibrosis and 3) cirrhosis. Predictive value of these sub-categories of liver fibrosis for SVR rate was to be assessed. | Predictive values of sub-categories of liver fibrosis could not be analyzed as the SVR24 rate was based on one participant. | Posted | Screening (before Week 1) |
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| Secondary | Predictive Value of HCV Disease Characteristics | HCV disease characteristics evaluated were HCV genotype (subtype), including HCV 1(a) and HCV 1(b). Predictive value of these disease characteristics for SVR rate were to be assessed. | Predictive values of HCV disease characteristics could not be analyzed as the SVR24 rate was based on one participant. | Posted | Screening (before Week 1) |
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| Secondary | Percentage of Participants With Positive Predictive Value of Previous Virological Response (Null-response, Partial Response, or Relapse) | Previous virological response was sub-categorized into the following categories: null-response, partial response, or relapse. Predictive value of these sub-categories for SVR rate were to be assessed. | Predictive values of previous virological response could not be analyzed as the SVR24 rate was based on one participant. | Posted | Up to 72 weeks |
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From signing of informed consent form up to the end of study (up to 72 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 | Triple Combination Therapy | Participants who demonstrated genotype 1 chronic hepatitis C infection and had a history of unsuccessful treatment with pegylated interferon (Peg-interferon) alfa + ribavirin, and who were subjected to receive a triple combination therapy with simeprevir or boceprevir plus peg-interferon alfa-2a and ribavirin were observed. | 5 | 19 | 14 | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Administration site cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza like illness | General disorders | MedDRA | Systematic Assessment |
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| Fatigue | General disorders | MedDRA | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | MedDRA | Systematic Assessment |
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| Aphthous ulcer | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Faeces soft | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| 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 |
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| ID | Term |
|---|---|
| C512204 | N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide |
| D000069616 | Simeprevir |
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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