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| Study to evaluate Pegasys® Sustained Viral Load (SVR) in genotype 3 Hepatitis C Virus (HCV) infected cirrhotic patients |
| Source of record | UK Trials |
| ISRCTN | ISRCTN59318247 |
| Date ISRCTN assigned | 08/02/2008 |
| Local reference number(s) | N/A |
| Public title | Study to evaluate Pegasys® Sustained Viral Load (SVR) in genotype 3 Hepatitis C Virus (HCV) infected cirrhotic patients |
| Scientific title | |
| Acronym | STEPS |
| Disease/condition/study domain | Hepatitis C/ cirrhosis |
| Study hypothesis | The primary measure of efficacy will be Sustained Viral Load (SVR) defined as the percentage of patients with undetectable HC RNA (<50 IU/ml) in Group A (24 weeks of treatment) compared to Group B (48 weeks of treatment). |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Main approval for Protocol Version 2.0 from Oxfordshire Research Ethics Committee (REC) C. Date of Approval: 22nd August 2007 (ref: 07/H0606/89) |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Age >18 years of age 2. Chronic genotype 3 HCV infection as evidenced by HCV antibody and RNA positivity with genotype 3 infection confirmed at a central laboratory 3. Liver biopsy within 18 months of entry showing features of chronic HCV infection and modified Ishak fibrosis score of equal to or greater than 4 OR radiological and/or endoscopic features of cirrhosis 4. HBsAg negative 5. No clinical evidence of co-infection with HIV 6. Platelet count >70,000 cells/mm3, neutrophil count >600 cells/mm3 7. Compensated liver disease (Child-Pugh Grade A clinical classification) 8. Negative urine pregnancy test result (for females of childbearing potential) documented within the 24-hour period prior to the first dose of study drugs. Additionally, all female patients of childbearing potential and all males with female partners of childbearing potential must use two forms of effective contraception (combined) during treatment and 6 months after treatment end 9. Able and willing to give informed consent and able to comply with study requirements |
| Participants - exclusion criteria | 1. Previous therapy for chronic HCV infection: InterFeroN alpha (IFN), PEG-IFN, ribavirin, viramidine, levovirin, or investigational HCV protease or polymerase inhibitors 2. Patients who are expected to need systemic antiviral therapy with established or perceived activity against HCV at any time during their participation in the study 3. Evidence of other cause of significant liver disease: serum ferritin >1,000, biochemical evidence of Wilson's disease, autoantibody titres in excess of 1:160 4. Platelet count <= 70,000 cells/mm3, neutrophil count <= 600 cells/mm3 5. Poorly controlled diabetes that, in the opinion of the investigator, precludes therapy 6. Severe retinopathy that, in the opinion of the investigator, precludes therapy 7. Decompensated cirrhosis (Childs Pugh B or C) 8. The use of colony stimulating factors such as Granulocyte Solony Stimulating Factor (G-CSF), erythropoietin or other therapeutic agents to elevate haematology parameters to facilitate patient entry into the study 9. Haemoglobin concentration <12 g/dL in females or <13 g/dL in males or any patient with a baseline increased risk for anaemia (e.g., thalassemia, sickle cell anaemia, spherocytosis, history of gastrointestinal bleeding) or for whom anaemia would be medically problematic 10. Females who are pregnant or breast-feeding 11. History of severe psychiatric disease, including psychosis and/or depression, characterized by a suicide attempt, hospitalization for psychiatric disease, or a period of disability as a result of psychiatric disease 12. History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune haemolytic anemia, scleroderma, severe psoriasis [defined as affecting >10% of the body, where the palm of one hand equals 1%, or if the hands and feet are affected], rheumatoid arthritis requiring more than intermittent nonsteroidal anti-inflammatory medications for management 13. History of severe cardiac disease (e.g., New York Heart Association [NYHA] Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases). In addition, patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled if, in the judgment of the investigator, an acute decrease in haemoglobin by up to 4 g/dL (as may be seen with ribavirin therapy) would not be well-tolerated 14. History of uncontrolled severe seizure disorder 15. Evidence of an active or suspected cancer or a history of malignancy within the last 2 years. Patients with a lesion suspicious for hepatic malignancy on an imaging study will be eligible only if the likelihood of carcinoma is <=10% following an appropriate evaluation 16. History of any systemic antineoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids or radiation) <=6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study 17. Other on-going serious medical condition in the opinion of the investigator that would prohibit treatment with Pegasys® or Copegus® 18. Poorly controlled thyroid dysfunction 19. History of major organ transplantation with an existing functional graft 20. Unable or willing to provide informed consent |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Anticipated start date | 19/11/2007 |
| Anticipated end date | 30/04/2009 |
| Status of trial | Ongoing |
| Target number of participants | 140 |
| Interventions | Group A: 180 mcg Pegasys® (subcutaneous) weekly and 800 mg Copegus® (oral) daily for 24 weeks Group B: 180 mcg Pegasys® (subcutaneous) weekly and 800 mg Copegus® (oral) daily for 48 weeks |
| Primary outcome measure(s) | The primary measure of efficacy will be SVR defined as the percentage of patients with undetectable HC RNA (<50 IU/ml) in Group A compared to Group B. All HCV RNA viral load measurements will be conducted with the Roche TaqMan HC test (See Secondary outcome measures for the timepoints of measurement). |
| Secondary outcome measure(s) | 1. SVR in Group A and B stratified by HCV viral load after 4 weeks of therapy (either <50 IU/ml or >= 50 IU/ml) 2. SVR in Group A and B stratified by HCV viral load after 12 weeks of therapy (either <50 IU/ml or >= 50 IU/ml) 3. Virological response at 4 weeks in Group A & B 4. Virological response at 12 weeks in Group A & B 5. Virological response at 24 weeks in Group A & B 6. Virological response at week 48 in Group B 7. Virological response in Group A + B by baseline parameters (Age, baseline fibrosis, baseline viral load) All HCV RNA viral load measurements will be conducted with the Roche TaqMan HC test. |
| Sources of funding | Roche (Switzerland) |
| Sponsor name | Queen Mary University of London & Barts and the London NHS Trust (UK) |
| Sponsor details | Research and Development Joint Research Office 24-26 Walden Street Whitechapel London United Kingdom E1 2AN |
| Sponsor website | http://www.bartsandthelondon.nhs.uk/research |
| Contact name | Mr Gerry Leonard |
| Contact details | Head of Research Resources Joint Research and Development Office Barts and the London NHS Trust 24-26 Walden Street Whitechapel London United Kingdom E1 2AN |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN59318247 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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