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This multi-center study will evaluate the viral response in patients with chronic hepatitis C, genotype 1, 2, 3 & 4 on standard anti-viral treatment with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin). Patients will receive weekly subcutaneous Pegasys plus daily oral Copegus for 24 weeks (genotype 2 & 3) or 48 weeks (genotype 1 & 4). Patients identified as slow responders/non-rapid virological responders will be eligible for an additional 24 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| peginterferon alfa-2a [Pegasys] | Drug | standard treatment, subcutaneously weekly |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Partial Early Virological Response (pEVR) to Study Treatment | The rate of participants with pEVR to study treatment was defined as ≥ 2 log reduction in HCV-RNA level from baseline value to Week 12 of study treatment but with detectable HCV-RNA at Week 12. | Week 12 |
| Percentage of Participants With Complete Early Virologic Response (cEVR) to Study Treatment | The rate of participants with a cEVR to study treatment was defined as negative HCV-RNA level at Week 12 of study treatment | Week 12 |
| Percentage of Participants With Undetectable HCV-RNA at End of Treatment Response (ETR) at Week 24 | The rate of participants with undetectable HCV-RNA at ETR at Week 24 was defined as at least a 2-log decrement in HCV-RNA from the start of treatment, but with detectable HCV-RNA at Week 12 of study treatment and undetectable HCV-RNA at Week 24 of study treatment | Week 24 |
| Percentage of Participants With Rapid Virologic Response (RVR) at Week 4 | The rate of participants with RVR was defined as negative HCV-RNA level at Week 4 of study treatment. | Week 4 |
| Percentage of Participants Without a RVR (Non-RVR) at Week 4 of Standard Treatment | The rate of participants without a RVR (non-RVR) was defined as detectible HCV-RNA level at Week 4 of standard treatment. | Week 4 |
| Percentage of Participants With Non-RVR and Undetectable HCV-RNA at Week 24 | The rate of participants with non-RVR and undetectable HCV-RNA at Week 24 was defined as detectable HCV-RNA level at Week 4 of study treatment and undetectable HCV-RNA at Week 24 of study. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With pEVR to Study Treatment at Week 12 | The rate of participants with pEVR to study treatment was defined as ≥ 2 log reduction in HCV-RNA level from baseline value to Week 12 of study treatment but with detectable HCV-RNA at Week 12. | Week 12 |
| Percentge of Participants With a cEVR to Study Treatmen at Week 12 of Study Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haemek Hospital; Gastroenterology | Afula | 18101 | Israel | |||
| Clalit City Ashdod MC; Liver Clinic |
A total of 1013 participants were enrolled in the study and 607 of them completed the study.
Male and female participants, 18 years of age and above with serologically proven genotype 1, 2, 3 or 4 CHC and treated with the standard combination treatment of peginterferon alfa-2a (Pegasys) and ribavirin (Copegus).
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| ID | Title | Description |
|---|---|---|
| FG000 | Pegylated Interferon Alfa 2a (Peginterferon) | Participants with chronic hepatitis C (CHC) were treated with subcutaneous pegylated interferon once weekly in combination with ribavirin once daily. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ribavirin [Copegus] |
| Drug |
standard treatment, orally daily |
|
| Week 24 |
The rate of participants with a cEVR to study treatment was defined as negative HCV-RNA level at Week 12 of study treatment. |
| Week 12 |
| Percentage of Participants With Undetectable HCV-RNA at Week 24, But With Detectable HCV-RNA atWeek 12 and Undetectable HCV-RNA at Week 24 | The rate of participants with undetectable HCV-RNA at ETR at Week 24 was defined as at least a 2-log decrement in HCV-RNA from the start of treatment, but with detectable HCV-RNA at Week 12 of study treatment and undetectable HCV-RNA at Week 24 of study treatment. | Week 24 |
| Ashdod |
| 77444 |
| Israel |
| Barzilai MC; Gastroenterology | Ashkelon | 78278 | Israel |
| Batyamon; Liver Unit | Bat Yam | Israel |
| Soroka Medical Center; Liver Unit | Beersheba | 8410101 | Israel |
| Soroka Medical Center; Gastroenterology | Beersheba | 84105 | Israel |
| Rambam Medical Center; Gastroenterology - Liver Unit | Haifa | 31096 | Israel |
| Bnei-Zion Medical Center; Gastroenterology | Haifa | 33394 | Israel |
| Carmel Hospital; Liver Unit | Haifa | 34362 | Israel |
| Wolfson Hospital; Gastroenterology Unit | Holon | 58100 | Israel |
| Hadassah Hospital; Liver Unit | Jerusalem | 91120 | Israel |
| Clalit Strauss MC | Jerusalem | 95146 | Israel |
| Meir Medical Center; Gastroenterology | Kfar Saba | 44281 | Israel |
| Naharyia / Western Galilee MC; Gastro Unit | Nahariya | 22100 | Israel |
| Holy Family Medical Center; Gastroenterology | Nazareth | Israel |
| Rabin Medical Center; Gastroenterology - Liver Unit | Petah Tikva | 49100 | Israel |
| Hasharon Mc; Gastroenterology | Petah Tikva | Israel |
| Chaim Sheba Medical Center; Gastroenterology | Ramat Gan | 52621 | Israel |
| Kaplan Medical Center; Gastroenterology Unit | Rehovot | 76100 | Israel |
| Clalit Pinsker Rishon; Liver Clinic | Rishon LeZiyyon | 75299 | Israel |
| Rebecca Sieff; Gastroenterology | Safed | 13110 | Israel |
| Sourasky / Ichilov Hospital; Gastroenterology - Liver Unit | Tel Aviv | 6423906 | Israel |
| Clalit Zamenhoff | Tel Aviv | 64353 | Israel |
| Maccabi Health Services MC | Tel Aviv | 67891 | Israel |
| Poria Hospital; Gastroenterology | Tiberias | Israel |
| Assaf Harofeh; Gastroenterology | Ẕerifin | 6093000 | Israel |
| Genotype 1 |
|
| Genotype 2 & 3 |
|
| Genotype 4 |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All participants who enrolled in the study
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| ID | Title | Description |
|---|---|---|
| BG000 | Pegylated Interferon Alfa 2a (Peginterferon) | Participants with chronic hepatitis C (CHC) were treated with subcutaneous pegylated interferon once weekly in combination with ribavirin once daily. |
| 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/Gender, Customized | Number | 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 Partial Early Virological Response (pEVR) to Study Treatment | The rate of participants with pEVR to study treatment was defined as ≥ 2 log reduction in HCV-RNA level from baseline value to Week 12 of study treatment but with detectable HCV-RNA at Week 12. | Participants with CHC Genotype 1 & 4 at week 12 | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 12 |
|
|
| |||||||||||||||||||||||||
| Primary | Percentage of Participants With Complete Early Virologic Response (cEVR) to Study Treatment | The rate of participants with a cEVR to study treatment was defined as negative HCV-RNA level at Week 12 of study treatment | Participants with CHC Genotype 1 & 4 at Week 12 | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 12 |
|
| ||||||||||||||||||||||||||
| Primary | Percentage of Participants With Undetectable HCV-RNA at End of Treatment Response (ETR) at Week 24 | The rate of participants with undetectable HCV-RNA at ETR at Week 24 was defined as at least a 2-log decrement in HCV-RNA from the start of treatment, but with detectable HCV-RNA at Week 12 of study treatment and undetectable HCV-RNA at Week 24 of study treatment | Participants with CHC Genotype 1 & 4 at Week 24 | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 24 |
|
| ||||||||||||||||||||||||||
| Primary | Percentage of Participants With Rapid Virologic Response (RVR) at Week 4 | The rate of participants with RVR was defined as negative HCV-RNA level at Week 4 of study treatment. | Participants with CHC Genotype 2 & 3 at Week 4 | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 4 |
|
| ||||||||||||||||||||||||||
| Primary | Percentage of Participants Without a RVR (Non-RVR) at Week 4 of Standard Treatment | The rate of participants without a RVR (non-RVR) was defined as detectible HCV-RNA level at Week 4 of standard treatment. | Participants with CHC Genotype 2 & 3 at Week 4 | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 4 |
|
| ||||||||||||||||||||||||||
| Primary | Percentage of Participants With Non-RVR and Undetectable HCV-RNA at Week 24 | The rate of participants with non-RVR and undetectable HCV-RNA at Week 24 was defined as detectable HCV-RNA level at Week 4 of study treatment and undetectable HCV-RNA at Week 24 of study. | Participants with CHC Genotype 2 & 3 at Week 24 | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 24 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With pEVR to Study Treatment at Week 12 | The rate of participants with pEVR to study treatment was defined as ≥ 2 log reduction in HCV-RNA level from baseline value to Week 12 of study treatment but with detectable HCV-RNA at Week 12. | As pre-specified in the protocol, genotypes 1 and 4 were combined due to insufficient enrollment for genotype 4. | Posted | Week 12 |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentge of Participants With a cEVR to Study Treatmen at Week 12 of Study Treatment | The rate of participants with a cEVR to study treatment was defined as negative HCV-RNA level at Week 12 of study treatment. | As pre-specified in the protocol, genotypes 1 and 4 were combined due to insufficient enrollment for genotype 4. | Posted | Week 12 |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Undetectable HCV-RNA at Week 24, But With Detectable HCV-RNA atWeek 12 and Undetectable HCV-RNA at Week 24 | The rate of participants with undetectable HCV-RNA at ETR at Week 24 was defined as at least a 2-log decrement in HCV-RNA from the start of treatment, but with detectable HCV-RNA at Week 12 of study treatment and undetectable HCV-RNA at Week 24 of study treatment. | As pre-specified in the protocol, genotypes 1 and 4 were combined due to insufficient enrollment for genotype 4. | Posted | Week 24 |
|
|
Baseline to Week 24
Safety population includes all enrolled participants
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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 2a (Peginterferon) | Participants with chronic hepatitis C (CHC) were treated with subcutaneous pegylated interferon once weekly in combination with ribavirin once daily. | 50 | 1,013 | 131 | 1,013 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Haemolytic anemia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Neutropenic fever | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
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| Optic nerve disorder | Eye disorders | MedDRA 19.1 | Systematic Assessment |
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| Optic Neuropathy | Eye disorders | MedDRA 19.1 | Systematic Assessment |
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| Retinal haemorrhage | Eye disorders | MedDRA 19.1 | Systematic Assessment |
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| Uveitis | Eye disorders | MedDRA 19.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| pancreatitis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal wall abcess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Tubo-ovarian abcess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Foot fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
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| Hepatic enzyme increased | Investigations | MedDRA 19.1 | Systematic Assessment |
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| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pancreatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
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| Cerebral hemorrhage | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Polyneuropathy | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Major depression | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
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| Metrorrhagia | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
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| Scrotal swelling | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
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| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Anal spincterotomy | Surgical and medical procedures | MedDRA 19.1 | Systematic Assessment |
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| Hernia repair | Surgical and medical procedures | MedDRA 19.1 | Systematic Assessment |
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| Inguinal hernia repair | Surgical and medical procedures | MedDRA 19.1 | Systematic Assessment |
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| Sigmoidectomy | Surgical and medical procedures | MedDRA 19.1 | Systematic Assessment |
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| Post thrombotic syndrome | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
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| Raynaud's phenomenon | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 19.1 | 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 | |
|---|---|---|---|---|
| Medical Communications | Hoffman-La Roche | 8008218590 | 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 |
|---|---|
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| Unknown |
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