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This open-label, multi-center study will evaluate the safety and tolerability and the effect on viral activity of a combined PEGASYS and COPEGUS extended therapy in patients with chronic hepatitis C with genotype 1, 2 and 3. Patients who completed 48 weeks (genotype 1) or 24 weeks (genotype 2 and 3) of standard treatment with PEGASYS and COPEGUS and were identified as slow virological responders will be enrolled in this study in order to receive additional 24 weeks of treatment. PEGASYS 180 micrograms will be administered sc once weekly and COPEGUS will be administered as 800 mg, or 1000-1200 mg daily oral doses. The anticipated time on study treatment is 24 weeks. The target sample size is 50-150 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COPEGUS | Drug | COPEGUS 800 mg or 1000-1200 mg po for 24 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| End of Treatment Response Rate at Week 72 in Genotype 1 | End of treatment response rate at Week 72 was reported for genotype 1. | Week 72 |
| End of Treatment Response in Genotype 2 and 3 | End of treatment response rate at Week 48 was reported for genotype 2 and 3. | Week 48 |
| Sustained Viral Response (SVR) Rates in CHC Genotype 1 | Sustained Viral Response, undetectable HCV-RNA 24 weeks after the end of treatment for genotype 1. | Week 96 |
| SVR Rates in Genotype 2 and 3. | Sustained Viral Response, undetectable HCV-RNA 24 weeks after the end of treatment for genotype 2 and 3. | Week 72 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Event (AE) | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | Week 96 |
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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 59 participants were enrolled in the study and 47 of them completed the study.
Participants from Study NCT01429792 with genotype 1 Chronic Hepatitis C (CHC) and were 'Slow Responders' were eligible to enroll in this treatment extension study. Participants from Study NCT01429792 with genotype 2 and 3 CHC and were non-Rapid Virologic Response (RVR) were eligible to enroll in this treatment extension study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pegylated Interferon (Peginterferon) Alfa-2a | Participants received pegylated interferon alfa-2a 180 microgram (mcg) in 0.5 milliliter (mL) solution administered subcutaneous (SC) once weekly for 24 weeks. Ribavirin was administered for 24 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| peginterferon alfa-2a [Pegasys] |
| Drug |
PEGASYS 180 micrograms sc once weekly for 24 weeks |
|
| Ashdod |
| 77444 |
| Israel |
| Batyamon; Liver Unit | Bat Yam | 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 |
| Kaplan Medical Center; Gastroenterology Unit | Rehovot | 76100 | Israel |
| Clalit Pinsker Rishon; Liver Clinic | Rishon LeZiyyon | 75299 | Israel |
| Rebecca Sieff Medical Center; Liver Unit | Safed | 13110 | Israel |
| Maccabi Health Services MC | Tel Aviv | 67891 | Israel |
| Poria Hospital; Gastroenterology | Tiberias | Israel |
| Assaf Harofeh; Gastroenterology | Ẕerifin | 6093000 | Israel |
| COMPLETED |
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| NOT COMPLETED |
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All enrolled participants were included in the baseline population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pegylated Interferon (Peginterferon) Alfa-2a | Participants received pegylated interferon alfa-2a 180 microgram (mcg) in 0.5 milliliter (mL) solution administered subcutaneous (SC) once weekly for 24 weeks. Ribavirin was administered for 24 weeks |
| 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 | End of Treatment Response Rate at Week 72 in Genotype 1 | End of treatment response rate at Week 72 was reported for genotype 1. | Participants with genotype 1 CHC at Week 72. | Posted | Number | Percentage of Participants | Week 72 |
|
|
| ||||||||||||||||||||||||||
| Primary | End of Treatment Response in Genotype 2 and 3 | End of treatment response rate at Week 48 was reported for genotype 2 and 3. | Participants with CHC Genotype 2 and 3 at Week 48. | Posted | Number | Percentage of Participants | Week 48 |
|
| |||||||||||||||||||||||||||
| Primary | Sustained Viral Response (SVR) Rates in CHC Genotype 1 | Sustained Viral Response, undetectable HCV-RNA 24 weeks after the end of treatment for genotype 1. | Participants with CHC genotype 1 at Week 96 | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 96 |
|
| ||||||||||||||||||||||||||
| Primary | SVR Rates in Genotype 2 and 3. | Sustained Viral Response, undetectable HCV-RNA 24 weeks after the end of treatment for genotype 2 and 3. | Participants with CHC Genotype 2 & 3 at week 72. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 72 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Event (AE) | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | All enrolled participants were analyzed | Posted | Number | Percentage of Participants | Week 96 |
|
|
Baseline to Week 96
Safety population included 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 Alfa2a (Peginterferon) | Participants received pegylated interferon alfa2a 180 microgram (mcg) in 0.5 milliliter (mL) solution administered subcutaneous (SC) once weekly for 24 weeks. Ribavirin was administered for 24 weeks. | 5 | 59 | 14 | 59 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Anal Abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Anaesthesia | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pregnancy of partner | Social circumstances | MedDRA 19.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 19.1 | 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 |
|---|---|
| D012254 | Ribavirin |
| C100416 | peginterferon alfa-2a |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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