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This study evaluated the safety and efficacy of peginterferon alfa-2a monotherapy in participants with Chronic Hepatitis C (CHC) who have End-Stage Renal Disease (ESRD) and were undergoing hemodialysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peginterferon alfa-2a 135 microgram (mcg) | Experimental | Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 135 mcg subcutaneously (SC) once weekly up to Week 48. |
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| Peginterferon alfa-2a 90 mcg | Experimental | Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 90 mcg SC once weekly up to Week 48. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alfa-2a | Drug | Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a either 135 or 90 mcg SC once weekly up to Week 48. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Treatment | SVR was defined as the percentage of patients with undetectable HCV RNA. SVR rate was calculated as the number of participants with an undetectable HCV RNA divided by the number of participants of the respective participant population. The last single HCV RNA less than (<) 50 international units per millilitre (IU/mL) measured >=140 days after treatment end (i.e., >= 20 weeks after treatment end) was used to determine SVR. Participants without measurements in this time window were considered to be nonresponders. | 24 weeks after end of treatment (Week 72) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Virological Response (Non-detectable Hepatitis C Virus-ribonucleic Acid [HCV RNA]) at End of Treatment (EOT) | Virological response at the end of study treatment was defined as the percentage of participants with undetectable HCV RNA. This response rate at end of treatment was calculated as the number of participants with undetectable HCV RNA divided by the number of participants of the respective participant population. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Graz | 8036 | Austria | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37096802 | Derived | Prabhu AR, Rao IR, Nagaraju SP, Rajwar E, Venkatesh BT, Nair N S, Pai G, Reddy NP, Suvarna D. Interventions for dialysis patients with hepatitis C virus (HCV) infection. Cochrane Database Syst Rev. 2023 Apr 25;4(4):CD007003. doi: 10.1002/14651858.CD007003.pub3. |
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A total of 85 participants were randomly assigned to the two treatment groups (Peginterferon alfa-2a 135 mcg/week and Peginterferon alfa-2a 90 mcg/week). A total of 4 randomized participants did not receive any study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | Peginterferon Alfa-2a 135 Microgram (mcg) | Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 135 mcg subcutaneously (SC) once weekly up to Week 48. |
| FG001 | Peginterferon Alfa-2a 90 mcg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| EOT (Week 48) |
| Percentage of Participants With Virological Response (at Least a 2-log 10 Decrease in HCV RNA as Compared With Baseline or Unquantifiable [Less Than {<} 600 International Unit/Milliliter {IU/mL}] or Undetectable HCV RNA [< 50 IU/mL]) at Week 12 and 24 | Virological response at Weeks 12 and 24 was computed as the percentage of participants with at least a 2-log 10 decrease in HCV RNA at Weeks 12 and 24 as compared with baseline or with an unquantifiable (< 600 IU/mL) or an undetectable HCV RNA test result (< 50 IU/mL) at Week 12 and at Week 24, calculated as the number of participants meeting this criterion divided by the number of participants of the respective participant population. | Weeks 12 and 24 |
| Vienna |
| 1090 |
| Austria |
| BrasÃlia | 70335-000 | Brazil |
| Porto Alegre | 90035-003 | Brazil |
| Sao Jose Rio Preto | 15090-003 | Brazil |
| São LuÃs | 78048-790 | Brazil |
| São Paulo | 04023-900 | Brazil |
| Créteil | 94010 | France |
| Le Kremlin-Bicêtre | 94275 | France |
| Marseille | 13385 | France |
| Paris | 75747 | France |
| Strasbourg | 67091 | France |
| Toulouse | 31059 | France |
| Athens | 11527 | Greece |
| Nikaia | 18354 | Greece |
| Medan | 20119 | Indonesia |
| Cagliari | 09134 | Italy |
| Istanbul | 34303 | Turkey (Türkiye) |
| Istanbul | 34390 | Turkey (Türkiye) |
| Istanbul | 34662 | Turkey (Türkiye) |
| Izmir | 35040 | Turkey (Türkiye) |
| Abu Dhabi | United Arab Emirates |
Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 90 mcg SC once weekly up to Week 48. |
| COMPLETED |
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| NOT COMPLETED |
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The intent-to-treat (ITT) analysis population included all the randomized participants who received at least one dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Peginterferon Alfa-2a 135 Microgram (mcg) | Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 135 mcg subcutaneously (SC) once weekly up to Week 48. |
| BG001 | Peginterferon Alfa-2a 90 mcg | Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 90 mcg SC once weekly up to Week 48. |
| BG002 | Total | Total of all reporting groups |
| 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 |
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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 | Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Treatment | SVR was defined as the percentage of patients with undetectable HCV RNA. SVR rate was calculated as the number of participants with an undetectable HCV RNA divided by the number of participants of the respective participant population. The last single HCV RNA less than (<) 50 international units per millilitre (IU/mL) measured >=140 days after treatment end (i.e., >= 20 weeks after treatment end) was used to determine SVR. Participants without measurements in this time window were considered to be nonresponders. | The ITT analysis population included all the randomized participants who received at least one dose of study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | 24 weeks after end of treatment (Week 72) |
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| Secondary | Percentage of Participants With Virological Response (Non-detectable Hepatitis C Virus-ribonucleic Acid [HCV RNA]) at End of Treatment (EOT) | Virological response at the end of study treatment was defined as the percentage of participants with undetectable HCV RNA. This response rate at end of treatment was calculated as the number of participants with undetectable HCV RNA divided by the number of participants of the respective participant population. | The ITT analysis population included all the randomized participants who received at least one dose of study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | EOT (Week 48) |
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| Secondary | Percentage of Participants With Virological Response (at Least a 2-log 10 Decrease in HCV RNA as Compared With Baseline or Unquantifiable [Less Than {<} 600 International Unit/Milliliter {IU/mL}] or Undetectable HCV RNA [< 50 IU/mL]) at Week 12 and 24 | Virological response at Weeks 12 and 24 was computed as the percentage of participants with at least a 2-log 10 decrease in HCV RNA at Weeks 12 and 24 as compared with baseline or with an unquantifiable (< 600 IU/mL) or an undetectable HCV RNA test result (< 50 IU/mL) at Week 12 and at Week 24, calculated as the number of participants meeting this criterion divided by the number of participants of the respective participant population. | The ITT analysis population included all the randomized participants who received at least one dose of study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 12 and 24 |
|
Baseline up to follow up period (Week 72)
An adverse event was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started.
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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 135 Microgram (mcg) | Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 135 mcg subcutaneously (SC) once weekly up to Week 48. | 14 | 38 | 30 | 38 | ||
| EG001 | Peginterferon Alfa-2a 90 mcg | Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 90 mcg SC once weekly up to Week 48. | 14 | 43 | 38 | 43 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Arthritis bacterial | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Bacterial infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Endocarditis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| Acute coronary syndrome | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| Coronary artery stenosis | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| Hypertrophic cardiomyopathy | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| Complex regional pain syndrome | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
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| Grand mal convulsion | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
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| Haemorrhagic stroke | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
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| Reversible posterior leukoencephalopathy syndrome | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
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| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| Poisoning | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| Hyperparathyroidism secondary | Endocrine disorders | MedDRA (10.0) | Systematic Assessment |
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| Chest pain | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Multi-organ failure | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Osteoporotic fracture | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
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| Parathyroid tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
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| Major depression | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
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| Gene mutation | Congenital, familial and genetic disorders | MedDRA (10.0) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Transplant rejection | Immune system disorders | MedDRA (10.0) | Systematic Assessment |
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| Medical observation | Investigations | MedDRA (10.0) | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
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| Metrorrhagia | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
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| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Ventricle rupture | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
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| Hyperparathyroidism secondary | Endocrine disorders | MedDRA (10.0) | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | MedDRA (10.0) | Systematic Assessment |
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| Conjunctivitis | Eye disorders | MedDRA (10.0) | Systematic Assessment |
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| Eye pain | Eye disorders | MedDRA (10.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Asthenia | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Chills | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Malaise | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (10.0) | 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 | 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 |
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| Male |
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| Units | Counts |
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| Participants |
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