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This single arm study will evaluate the safety and tolerability of ribavirin in combination with PEGASYS in patients with chronic hepatitis C. Patients will receive ribavirin 800mg, or 1000-1200mg po daily, according to HCV genotype and body weight (< and >75kg)in combination with PEGASYS 180micrograms sc weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is >500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| peginterferon alfa-2a [Pegasys] | Drug | 180micrograms sc weekly for 12-48 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Non-Serious Adverse Events (AEs) And Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs were exclusive of serious AEs. | From signing of informed consent up to end of study (up to Week 72) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Therapy | SVR at 24 weeks after end of therapy was defined as a negative result of HCV Ribonucleic Acid (HCV RNA) qualitative assay 24 weeks after end of therapy. Percentage of participants with SVR was calculated as [number of participants with negative results of HCV RNA qualitative assay 24 weeks after end of therapy divided by the total number of participants analyzed] multiplied by 100. The participants who failed to undergo tests at 24 weeks after completion of therapy were considered not amenable to therapy. |
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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 |
|---|---|---|---|---|---|---|
| Arkhangelsk | 163000 | Russia | ||||
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A total of 7799 participants were screened, of which 6661 participants were included in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ribavirin + Peginterferon Alfa-2a | Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kilograms (kg) received dose of 400 milligrams (mg) (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with Peginterferon (PEG-INF) Alfa-2a 180 micrograms per milliliter (µg/mL) subcutaneous (SC) injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ribavirin |
| Drug |
800mg, or 1000-1200mg, po daily (dependent on HCV genotype and body weight) |
|
| 24 weeks after end of therapy (Week 72) |
| Percentage of Participants With Undetectable HCV RNA at Weeks 12, 24 and 48 After Therapy Initiation | HCV RNA levels of < 50 International Units per milliliter (IU/mL) were defined as undetectable HCV RNA. The percentage of participants with undetectable HCV RNA was calculated as [number of participants with undetectable HCV RNA divided by the total number of participants analyzed] multiplied by 100 for Weeks 12, 24 and 48. | Weeks 12,24 and 48 After Therapy Initiation |
| Percentage of Participants With Change in Hemoglobin Level | Change in hemoglobin level (compared to baseline) was reported as "significant decrease", "Normal" (no change), "Increase", "Decrease", and "Missing". Significant decrease was defined as per Investigator's discretion. | Baseline, Weeks 2, 4, 8, 12, 24, 36, 48 and follow-up Weeks 4 (Week 52), 12 (Week 60), and 24 (Week 72) |
| Barnaul |
| 656010 |
| Russia |
| Barnaul | 656045 | Russia |
| Blagoveshchensk | 675007 | Russia |
| Cheboksary | 428016 | Russia |
| Chelyabinsk | 454048 | Russia |
| Chelyabinsk | 454052 | Russia |
| Chelyabinsk | 454071 | Russia |
| Cherepovets | 162600 | Russia |
| Chita | 672090 | Russia |
| Irkutsk | 664043 | Russia |
| Irkutsk | 664047 | Russia |
| Irkutsk | 664079 | Russia |
| Izhevsk | 426067 | Russia |
| Kazan' | 420097 | Russia |
| Kemerovo | 650000 | Russia |
| Kemerovo | 650036 | Russia |
| Kemerovo | 650099 | Russia |
| Khabarovsk | 680009 | Russia |
| Khabarovsk | 680022 | Russia |
| Khabarovsk | 680031 | Russia |
| Kirov | 610000 | Russia |
| Krasnodar | 350012 | Russia |
| Krasnodar | 350015 | Russia |
| Krasnodar | 350086 | Russia |
| Krasnoyarsk | 660022 | Russia |
| Krasnoyarsk | 660049 | Russia |
| Lipetsk | 398043 | Russia |
| Makhachkala | 367008 | Russia |
| Moscow | 103875 | Russia |
| Moscow | 105203 | Russia |
| Moscow | 109325 | Russia |
| Moscow | 111020 | Russia |
| Moscow | 111123 | Russia |
| Moscow | 115201 | Russia |
| Moscow | 115446 | Russia |
| Moscow | 115516 | Russia |
| Moscow | 115682 | Russia |
| Moscow | 119002 | Russia |
| Moscow | 119881 | Russia |
| Moscow | 121293 | Russia |
| Moscow | 123098 | Russia |
| Moscow | 123367 | Russia |
| Moscow | 125101 | Russia |
| Moscow | 125367 | Russia |
| Moscow | 127247 | Russia |
| Moscow | 129110 | Russia |
| Moscow | 143420 | Russia |
| Moscow | Russia |
| Nizhny Novgorod | 603022 | Russia |
| Novokuznetsk | 654018 | Russia |
| Novokuznetsk | 654029 | Russia |
| Novosibirsk | 630016 | Russia |
| Novoural'sk | 624130 | Russia |
| Omsk | 644010 | Russia |
| Orenburg | 460035 | Russia |
| Petropavlovsk-Kamchatskiy | 683003 | Russia |
| Rostov-on-Don | 344022 | Russia |
| Saint Petersburg | 191167 | Russia |
| Saint Petersburg | 194044 | Russia |
| Saint Petersburg | 194291 | Russia |
| Saint Petersburg | 195067 | Russia |
| Saint Petersburg | 195275 | Russia |
| Saint Petersburg | 197022 | Russia |
| Saint Petersburg | 198103 | Russia |
| Saint Petersburg | 199034 | Russia |
| Salekhard | 629001 | Russia |
| Samara | 443011 | Russia |
| Samara | 443021 | Russia |
| Saratov | 410026 | Russia |
| Saratov | 410028 | Russia |
| Saratov | 410040 | Russia |
| Sashi | 354057 | Russia |
| Stavropol | 355017 | Russia |
| Surgut | 628400 | Russia |
| Tomsk | 634050 | Russia |
| Tyumen | 625002 | Russia |
| Tyumen | 625017 | Russia |
| Tyumen | 625026 | Russia |
| Tyumen | 629806 | Russia |
| Ufa | 450000 | Russia |
| Ufa | 450005 | Russia |
| Ulan-Ude | 670042 | Russia |
| Vladivostok | 690011 | Russia |
| Vladivostok | 690065 | Russia |
| Volgograd | 400040 | Russia |
| Volgograd | 400138 | Russia |
| Yakutsk | 677000 | Russia |
| Yekaterinburg | 620020 | Russia |
| Yekaterinburg | 620042 | Russia |
| Yekaterinburg | 620102 | Russia |
| Yujno-sakhalinsk | 690000 | Russia |
| Yujno-sakhalinsk | 693000 | Russia |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline population included all enrolled participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ribavirin + Peginterferon Alfa-2a | Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 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 | Here, number of participants analyzed for baseline measure "age" was 6622. | 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 | Number of Participants With Non-Serious Adverse Events (AEs) And Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs were exclusive of serious AEs. | Safety analysis population included all participants who received at least one therapeutic dose of ribavirin. | Posted | Number | Participants | From signing of informed consent up to end of study (up to Week 72) |
|
|
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Therapy | SVR at 24 weeks after end of therapy was defined as a negative result of HCV Ribonucleic Acid (HCV RNA) qualitative assay 24 weeks after end of therapy. Percentage of participants with SVR was calculated as [number of participants with negative results of HCV RNA qualitative assay 24 weeks after end of therapy divided by the total number of participants analyzed] multiplied by 100. The participants who failed to undergo tests at 24 weeks after completion of therapy were considered not amenable to therapy. | Intent-to-treat (ITT) population included all participants who received at least one therapeutic dose of ribavirin. | Posted | Number | Percentage of Participants | 24 weeks after end of therapy (Week 72) |
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Undetectable HCV RNA at Weeks 12, 24 and 48 After Therapy Initiation | HCV RNA levels of < 50 International Units per milliliter (IU/mL) were defined as undetectable HCV RNA. The percentage of participants with undetectable HCV RNA was calculated as [number of participants with undetectable HCV RNA divided by the total number of participants analyzed] multiplied by 100 for Weeks 12, 24 and 48. | ITT Population. | Posted | Number | Percentage of Participants | Weeks 12,24 and 48 After Therapy Initiation |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Change in Hemoglobin Level | Change in hemoglobin level (compared to baseline) was reported as "significant decrease", "Normal" (no change), "Increase", "Decrease", and "Missing". Significant decrease was defined as per Investigator's discretion. | ITT Population. | Posted | Number | Percentage of Participants | Baseline, Weeks 2, 4, 8, 12, 24, 36, 48 and follow-up Weeks 4 (Week 52), 12 (Week 60), and 24 (Week 72) |
|
|
From signing of informed consent up to end of study (up to Week 72)
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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 | Ribavirin + Peginterferon Alfa-2a | Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks. | 67 | 6,661 | 1,674 | 6,661 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyelonephritis acute | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Acute tonsillitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Chronic hepatitis C | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Enteritis infectious | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hepatitis G | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cardiovascular insufficiency | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Delusional disorder, persecutory type | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Autonomic nervous system imbalance | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cranial nerve disorder | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| IIIrd nerve disorder | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Intracranial pressure increased | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Vascular encephalopathy | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Vasculitis | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Autoimmune thyroiditis | Endocrine disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Mixed connective tissue disease | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Von Willebrand's disease | Congenital, familial and genetic disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Macular oedema | Eye disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Sarcoidosis | Immune system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Chronic tonsillitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Weight loss poor | Metabolism and nutrition disorders | MedDRA 15.0 | Non-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 | Hoffmann-LaRoche | 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| Missing |
|
| Units | Counts |
|---|
| Participants |
|
|
|
|