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This single arm study will investigate the predictive value of a week 4 virological response on sustained virological response in patients with chronic hepatitis C, genotype 2 or 3, treated with PEGASYS + Copegus. Eligible patients will be treated with PEGASYS 180 micrograms/week sc + Copegus 800mg/day po; those who have a virological response at week 4 will continue to be treated for 24 weeks, followed by a 24 week treatment-free follow-up. Non-responders at week 4 will be entered into a separate protocol (MV21371) to receive PEGASYS + Copegus for 24 or 48 weeks. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peginterferon Alfa-2a + Ribavirin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| peginterferon alfa-2a [Pegasys] | Drug | 180 micrograms/week sc for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virological Response at Week 48 | Sustained Virological Response (SVR) is defined as participants with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks after the last dose of study drug. The detection limit of HCV RNA was 15 international units (IU) per milliliter (mL) by qualitative polymerase chain reaction (PCR). | At Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Rapid Virological Response at Week 4 | Rapid Virological Response (RVR) is defined as participants with) undetectable HCV RNA at 4 weeks after initiation of the treatment period. The detection limit of HCV RNA was 15 IU/mL by qualitative PCR. | At Week 4 |
| Percentage of Participants With Virological Response at Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with serologically proven chronic hepatitis C and genotype 2 or 3, with or without cirrhosis and compensated liver disease (Child-Pugh A cirrhosis.)
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vitória | Espírito Santo | 29043-260 | Brazil | |||
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A total of 262 participants were enrolled from 13 centers in Brazil. This study was conducted between 26 November 2008 and 19 November 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Peginterferon Alfa-2a + Ribavirin | Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ribavirin [Copegus] | Drug | 800mg po daily for 24 weeks |
|
Virological response is defined as participants with undetectable HCV RNA after the last dose of study drug (Week 24). |
| At Week 24 |
| Percentage of Participants With Virological Relapse | Virological relapse is defined as participants with virological response (undetectable HCV RNA) but did not achieve SVR. | At week 48 |
| Percentage of Participants With Positive Predictive Value | Positive predictive value is defined as participants with RVR who did not achieve SVR. | At Week 48 |
| Number of Participants With Any Adverse Events and Any Serious Adverse Events | An any adverse events (AEs) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An serious adverse events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. | Up to 48 weeks |
| Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48 | Hematology parameters included hemoglobin, hematocrit, leukocytes, neutrophils and platelets. | At Baseline (Day 0), Week 2, Week 4, Week 12, Week 24 and Week 48 |
| Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | Biochemistry parameters included alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamyl transpeptidase (Gamma-GT),fasting cholesterol, blood glucose, insulin, total bilirubin, creatinine, triglycerides, homeostatic model assessment score, prothrombin time (PT) and international normalized ratio (INR). The homeostatic model assessment (HOMA) score is a method used to quantify insulin resistance. HOMA score = (fasting glucose in mg/dL × fasting insulin in μIU/mL) / 405. A normal participant can have a HOMA score up to 3. A patient with a score of >3 is definitely insulin resistance. Low HOMA score indicate high insulin resistance, whereas high HOMA score indicate low insulin resistance. | Baseline, Week 4, Week 12, Week 24 and Week 48 |
| Brasília |
| Federal District |
| 70335900 |
| Brazil |
| São Luís | Maranhão | 65020560 | Brazil |
| Rio de Janeiro | Rio de Janeiro | 20020-022 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90020-090 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90035-003 | Brazil |
| Campinas | São Paulo | 13060-803 | Brazil |
| Campinas | São Paulo | 13083-888 | Brazil |
| Ribeirão Preto | São Paulo | 14049-900 | Brazil |
| Santo André | São Paulo | 09060-650 | Brazil |
| São Paulo | São Paulo | 04040-003 | Brazil |
| Sorocaba | São Paulo | 18047-600 | Brazil |
| COMPLETED |
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| NOT COMPLETED |
|
|
Intention-to-treat (ITT) population included all participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Peginterferon Alfa-2a + Ribavirin | Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 |
|
| 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 | Percentage of Participants With Sustained Virological Response at Week 48 | Sustained Virological Response (SVR) is defined as participants with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks after the last dose of study drug. The detection limit of HCV RNA was 15 international units (IU) per milliliter (mL) by qualitative polymerase chain reaction (PCR). | Intention-to-treat (ITT) population included all participants who received at least one dose of study drug. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Week 48 |
|
|
| |||||||||||||||||||||||||
| Secondary | Percentage of Participants With Rapid Virological Response at Week 4 | Rapid Virological Response (RVR) is defined as participants with) undetectable HCV RNA at 4 weeks after initiation of the treatment period. The detection limit of HCV RNA was 15 IU/mL by qualitative PCR. | Intention-to-treat (ITT) population included all participants who received at least one dose of study drug. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Week 4 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Virological Response at Week 24 | Virological response is defined as participants with undetectable HCV RNA after the last dose of study drug (Week 24). | Intention-to-treat (ITT) population included all participants who received at least one dose of study drug. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Week 24 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Virological Relapse | Virological relapse is defined as participants with virological response (undetectable HCV RNA) but did not achieve SVR. | Intention-to-treat (ITT) population included all participants who received at least one dose of study drug. | Posted | Number | 95% Confidence Interval | Percentage of participants | At week 48 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Positive Predictive Value | Positive predictive value is defined as participants with RVR who did not achieve SVR. | Intention-to-treat (ITT) population included all participants who received at least one dose of study drug. Data of participants available at the assessment time point were included in the analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 48 |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Any Adverse Events and Any Serious Adverse Events | An any adverse events (AEs) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An serious adverse events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. | Intention-to-treat (ITT) population included all participants who received at least one dose of study drug. | Posted | Number | participants | Up to 48 weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48 | Hematology parameters included hemoglobin, hematocrit, leukocytes, neutrophils and platelets. | Intention-to-treat (ITT) population included all participants who received at least one dose of study drug. Data of participants available at the assessment time point were included in the analysis. 'n' is number of participants analyzed at the specified weeks. | Posted | Mean | Standard Error | Percent change | At Baseline (Day 0), Week 2, Week 4, Week 12, Week 24 and Week 48 |
|
| ||||||||||||||||||||||||||
| Secondary | Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | Biochemistry parameters included alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamyl transpeptidase (Gamma-GT),fasting cholesterol, blood glucose, insulin, total bilirubin, creatinine, triglycerides, homeostatic model assessment score, prothrombin time (PT) and international normalized ratio (INR). The homeostatic model assessment (HOMA) score is a method used to quantify insulin resistance. HOMA score = (fasting glucose in mg/dL × fasting insulin in μIU/mL) / 405. A normal participant can have a HOMA score up to 3. A patient with a score of >3 is definitely insulin resistance. Low HOMA score indicate high insulin resistance, whereas high HOMA score indicate low insulin resistance. | Intention-to-treat (ITT) population included all participants who received at least one dose of study drug. Data of participants available at the assessment time point were included in the analysis. 'n' is number of participants analyzed at the specified weeks. | Posted | Mean | Standard Error | Percent change | Baseline, Week 4, Week 12, Week 24 and Week 48 |
|
Up to 48 weeks
Serious adverse events (SAEs) and non-serious AEs were reported for the safety population which included all participants who received at least one dose of study drug.
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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 Alfa-2a + Ribavirin | Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed. | 13 | 262 | 179 | 262 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Anorectal operation | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Salivary gland mass | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Syncope | Nervous 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 |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Insomnia | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
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 | |
|---|---|---|---|---|
| Roche Trial Information Hotline | F. Hoffmann-La Roche AG | +41 616878333 | global.trial_information@roche.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 |
|---|---|
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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