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This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic hepatitis C and end-stage renal disease, including patients on hemodialysis. Patients will receive PEGASYS at a dose of 180 micrograms weekly; those with a calculated glomerular filtration rate of <15mL/min will receive a reduced dose of 135 micrograms weekly. Following 48 weeks of treatment there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peginterferon Alpha-2a | Experimental | Eligible participants will be administered peginterferon alpha-2a [Pegasys] (40 kilo Dalton), 180 micrograms as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated glomerular filtration rate of <15 milliliter /minute will be administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| peginterferon alfa-2a [Pegasys] | Drug | 180 micrograms or 135 micrograms sc weekly for 48 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Sustained Virologic Response at 24 Weeks Following Treatment Completion | Sustained virologic response is defined as undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels (<50 international units [IU]/mL) at 24 weeks following the completion of 48 weeks treatment period (Week 72). | At Week 72 |
| Percentage of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid Level at Week 24 and Week 48 | HCV RNA level less than 50 IU/mL was considered to be undetectable. | At Week 24 and Week 48 |
| Percentage of Participants With At Least a 2log10 Drop in Hepatitis C Virus Ribonucleic Acid at Week 24 as Compared to Baseline | The table below shows the percentage of participants with at least 2log10 drop in HCV RNA level at Week 24 as compared to Baseline (Screening visit [Days -30 to -1]). | From Baseline (Days -30 to -1) and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events | An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be 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. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect |
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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 |
|---|---|---|---|---|---|---|
| Chita | 672090 | Russia | ||||
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A total of 27 participants were enrolled in this study conducted from 2006 to 2011 at 5 centers in Russian Federation.
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| ID | Title | Description |
|---|---|---|
| FG000 | Peginterferon Alpha-2a | Eligible participants were administered peginterferon alpha-2a [Pegasys] [40 kilo Dalton (kDa)], 180 micrograms (mcg) as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated glomerular filtration rate (GFR) of <15 milliliter (mL)/minute (min) were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent-to-treat (ITT) population included all enrolled participants who received at least one dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Peginterferon Alpha-2a | Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 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 |
| 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 Achieving Sustained Virologic Response at 24 Weeks Following Treatment Completion | Sustained virologic response is defined as undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels (<50 international units [IU]/mL) at 24 weeks following the completion of 48 weeks treatment period (Week 72). | ITT population included all enrolled participants who received at least one dose of study medication. | Posted | Number | Percentage of participants | At Week 72 |
|
Up to Week 72
All SAEs and AEs were collected for safety population included all enrolled participants who received at least one dose of study medication, whether withdrawn prematurely or not, and who had at least one follow-up data point were included.
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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 Alpha-2a | Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDra version 17.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDra version 17.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roche Trial Information Hotline | F. Hoffmann-La Roche AG | +41 616878333 | global.trial_information@roche.com |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
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| Up to Week 72 |
| Number of Participants Who Prematurely Withdrew From the Treatment Over a Period of 48 Weeks | Participants who prematurely withdrew from the treatment for the following reasons: personal reasons (not related to the study), adverse events, and drug unavailability, are presented. | Up to Week 48 |
| Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks | Marked abnormal laboratory parameters included serum glutamic pyruvic transaminase (SGPT), serum glutamic oxaloacetic transaminase (SGOT), gamma-glutamyl transpeptidase (GGTP), total bilirubin, alkaline phosphatase (ALP), ferritin and transferrin saturation. These laboratory parameters were evaluated at Baseline (Screening visit [Days -30 to -1]) and at various Visits (V): Week 0 (V1), Week 2 (V2), Week 4 (V3), Week 12 (V4), Week 24 (V5), Week 36 (V6) and Week 48 (V7) and after treatment completion at follow-up (FU) Week 4 (Week 52, V8), FU Week 12 (Week 60, V9), and FU Week 24 (Week 72, V10). | Up to Week 72 |
| Mean Change From Baseline in Blood Pressure up to Week 72 | Mean change from Baseline in diastolic blood pressure (DBP) and systolic blood pressure (SBP) was recorded at Baseline (Screening visit [Days -30 to -1]) and at various Visits (V): Week 2 (V2), Week 4 (V3), Week 12 (V4), Week 24 (V5), Week 36 (V6) and Week 48 (V7) and after treatment completion at follow-up (FU) Week 4 (Week 52, V8), FU Week 12 (Week 60, V9), and FU Week 24 (Week 72, V10). | From Baseline (Days -30 to -1) to Week 72 |
| Mean Change From Baseline in Heart Rate up to Week 72 | Mean change from baseline in heart rate was recorded at Baseline (Screening visit [Days -30 to -1]), and at various Visits (V): Week 2 (V2), Week 4 (V3), Week 12 (V4), Week 24 (V5), Week 36 (V6) and Week 48 (V7), and after treatment completion at follow-up (FU) Week 4 (Week 52, V8), FU Week 12 (Week 60, V9), and FU Week 24 (Week 72, V10). | From Baseline (Days -30 to -1) to Week 72 |
| Irkutsk |
| 664047 |
| Russia |
| Khabarovsk | 680009 | Russia |
| Khabarovsk | 680022 | Russia |
| Orenburg | 460040 | Russia |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Percentage of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid Level at Week 24 and Week 48 | HCV RNA level less than 50 IU/mL was considered to be undetectable. | ITT population included all enrolled participants who received at least one dose of study medication. | Posted | Number | Percentage of participants | At Week 24 and Week 48 |
|
|
|
| Primary | Percentage of Participants With At Least a 2log10 Drop in Hepatitis C Virus Ribonucleic Acid at Week 24 as Compared to Baseline | The table below shows the percentage of participants with at least 2log10 drop in HCV RNA level at Week 24 as compared to Baseline (Screening visit [Days -30 to -1]). | ITT population included all enrolled participants who received at least one dose of study medication. | Posted | Number | Percentage of participants | From Baseline (Days -30 to -1) and Week 24 |
|
|
|
| Secondary | Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events | An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be 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. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect | Safety population included all enrolled participants who received at least one dose of study medication, whether withdrawn prematurely or not, and who had at least one follow-up data point were included. | Posted | Number | Participants | Up to Week 72 |
|
|
|
| Secondary | Number of Participants Who Prematurely Withdrew From the Treatment Over a Period of 48 Weeks | Participants who prematurely withdrew from the treatment for the following reasons: personal reasons (not related to the study), adverse events, and drug unavailability, are presented. | ITT population included all enrolled participants who received at least one dose of study medication. | Posted | Number | Participants | Up to Week 48 |
|
|
|
| Secondary | Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks | Marked abnormal laboratory parameters included serum glutamic pyruvic transaminase (SGPT), serum glutamic oxaloacetic transaminase (SGOT), gamma-glutamyl transpeptidase (GGTP), total bilirubin, alkaline phosphatase (ALP), ferritin and transferrin saturation. These laboratory parameters were evaluated at Baseline (Screening visit [Days -30 to -1]) and at various Visits (V): Week 0 (V1), Week 2 (V2), Week 4 (V3), Week 12 (V4), Week 24 (V5), Week 36 (V6) and Week 48 (V7) and after treatment completion at follow-up (FU) Week 4 (Week 52, V8), FU Week 12 (Week 60, V9), and FU Week 24 (Week 72, V10). | ITT population included all enrolled participants who received at least one dose of study medication. | Posted | Number | Participants | Up to Week 72 |
|
|
|
| Secondary | Mean Change From Baseline in Blood Pressure up to Week 72 | Mean change from Baseline in diastolic blood pressure (DBP) and systolic blood pressure (SBP) was recorded at Baseline (Screening visit [Days -30 to -1]) and at various Visits (V): Week 2 (V2), Week 4 (V3), Week 12 (V4), Week 24 (V5), Week 36 (V6) and Week 48 (V7) and after treatment completion at follow-up (FU) Week 4 (Week 52, V8), FU Week 12 (Week 60, V9), and FU Week 24 (Week 72, V10). | ITT population included all enrolled participants who received at least one dose of study medication. Number of participants evaluable at a particular visit was determined by 'n'. | Posted | Mean | Standard Deviation | Millimeter (mm) of Mercury | From Baseline (Days -30 to -1) to Week 72 |
|
|
|
| Secondary | Mean Change From Baseline in Heart Rate up to Week 72 | Mean change from baseline in heart rate was recorded at Baseline (Screening visit [Days -30 to -1]), and at various Visits (V): Week 2 (V2), Week 4 (V3), Week 12 (V4), Week 24 (V5), Week 36 (V6) and Week 48 (V7), and after treatment completion at follow-up (FU) Week 4 (Week 52, V8), FU Week 12 (Week 60, V9), and FU Week 24 (Week 72, V10). | ITT population included all enrolled participants who received at least one dose of study medication. Number of participants evaluable at a particular visit was determined by 'n'. | Posted | Mean | Standard Deviation | Beats per minute (bpm) | From Baseline (Days -30 to -1) to Week 72 |
|
|
|
| 2 |
| 27 |
| 10 |
| 27 |
| Right acromioclavicular joint dislocation | Injury, poisoning and procedural complications | MedDra version 17.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDra version 17.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDra version 17.1 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDra version 17.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDra version 17.1 | Systematic Assessment |
|
| Erythema nodosum | Skin and subcutaneous tissue disorders | MedDra version 17.1 | Systematic Assessment |
|
| Weber-Christian disease | Skin and subcutaneous tissue disorders | MedDra version 17.1 | 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.
| 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 |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| SGPT Increased, V3 |
|
| SGPT Increased, V4 |
|
| SGPT Increased, V5 |
|
| SGPT Increased, V6 |
|
| SGPT Increased, V7 |
|
| SGPT Increased, V8 |
|
| SGPT Increased, V9 |
|
| SGPT Increased, V10 |
|
| SGOT Increased, Baseline |
|
| SGOT Increased, V3 |
|
| GGTP Increased, V3 |
|
| Total bilirubin Increased, Baseline |
|
| ALP Increased Baseline |
|
| ALP Increased, V3 |
|
| Ferritin Increased, Baseline |
|
| Ferritin Decreased, Baseline |
|
| Ferritin Increased, V1 |
|
| Ferritin Increased, V4 |
|
| Ferritin Increased, V5 |
|
| Ferritin Increased, V7 |
|
| Transferrin saturation Increased, Baseline |
|
| Transferrin saturation Decreased, Baseline |
|
| Transferrin saturation Increased, V1 |
|
| Transferrin saturation Decreased, V1 |
|
| Transferrin saturation Increased, V4 |
|
| Transferrin saturation Increased, V5 |
|
| Transferrin saturation Decreased, V5 |
|
| Transferrin saturation Increased, V7 |
|
| Title | Measurements |
|---|---|
|
| DBP, V5, n=23 |
|
| DBP, V6, n=23 |
|
| DBP, V7, n=19 |
|
| DBP, V8, n=27 |
|
| DBP, V9, n=21 |
|
| DBP, V10, n=21 |
|
| SBP, V2, n=27 |
|
| SBP, V3, n=27 |
|
| SBP, V4, n=26 |
|
| SBP, V5, n=23 |
|
| SBP, V6, n=23 |
|
| SBP, V7, n=19 |
|
| SBP, V8, n=27 |
|
| SBP, V9, n=21 |
|
| SBP, V10, n=21 |
|
| Title | Measurements |
|---|---|
|
| V5, n=23 |
|
| V6, n=23 |
|
| V7, n=19 |
|
| V8, n=27 |
|
| V9, n=21 |
|
| V10, n=21 |
|