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| [ Print-friendly version ] |
| Health benefits from anti-viral therapy for mild chronic hepatitis C |
| ISRCTN | ISRCTN24461054 |
| ClinicalTrials.gov identifier | |
| Public title | Health benefits from anti-viral therapy for mild chronic hepatitis C |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | HTA 95/24/03 |
| Study hypothesis | A multicentre, randomised study comparing interferon and ribavarin with no treatment for patients with mild chronic Hepatitis C. |
| Ethics approval | Added as of 23/07/2007: Ethics committee approval was obtained both centrally (MREC/98/2/12) and from each Local Centre Committee (LREC). |
| Study design | Multicentre, randomised, controlled, non-blinded trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Infection and infestations: Hepatitis |
| Participants - inclusion criteria |
Inclusion criteria updated as of 24/07/2007:
1. Adult, male or female, minimum age of 18 years 2. Serum positive for HCV by quantitative Polymerase Chain Reaction (qPCR) assay 3. Liver biopsy within 1 year before entry to the protocol. Histological diagnosis consistent with mild chronic hepatitis (Ishak necroinflammatory score <4, fibrosis score <3) 4. Compensated liver disease with the following minimum haematological, biochemical and serological criteria at the screening visit: 4.1. Haemoglobin (Hb) ≥12 g dl–1 for women and ≥13 g dl–1 for men 4.2. White Blood Cell count (WBC) ≥ 3000 mm–3 4.3. Granulocyte count ≥1500 mm–3 4.4. Platelets ≥100,000 mm–3 4.5. Prothrombin time/ International Normalised Ratio (INR) within normal limits 4.6. Bilirubin within normal limits (unless non-hepatitis-related factors such as Gilbert’s disease explain a rise) 4.7. Albumin stable and within normal limits 4.8. Serum creatinine within normal limits 4.9. Fasting blood sugar within normal limits for non-diabetic patients 4.10. Glycosylated haemoglobin (HbA1c) <8.5% for diabetic patients (whether diet controlled or on medication) 4.11. TSH within normal limits (patients requiring medication to maintain Thyroid-Stimulating Hormone (TSH) levels in the normal range were eligible if all other inclusion/exclusion criteria were met) 4.12. AntiNuclear Antibodies (ANA) <1:160 4.13. Anti-HIV antibody negative 4.14. Serum hepatitis B surface antigen (HBsAg) negative 5. Confirmation and documentation that sexually active patients of childbearing potential were practising adequate contraception during the treatment period and for 6 months after discontinuation of therapy. A serum pregnancy test was obtained at entry before the initiation of treatment and had to be negative. Female patients could not breast-feed. Inclusion criteria provided at time of registration: Patients with hepatitis C |
| Participants - exclusion criteria |
Exclusion criteria added as of 24/07/2007:
1. Prior treatment with interferon-alpha or ribavirin 2. Hypersensitivity to interferon-alpha or ribavirin 3. Participation in any other clinical trial within 30 days of entry to this protocol 4. Treatment with any investigational drug within 30 days of entry to this protocol 5. Prior treatment for hepatitis with any other antiviral or immunomodulatory drug within the previous 2 years 6. Any other cause for the liver disease other than chronic hepatitis C, including but not limited to: 6.1. Coinfection with hepatitis B virus 6.2. Haemochromatosis (iron deposition >2+ in liver parenchyma) 6.3. Alpha1-antitrypsin deficiency 6.4. Wilson’s disease 6.5. Autoimmune hepatitis 6.6. Alcoholic liver disease 6.7. Obesity-induced liver disease 6.8. Drug-related liver disease 7. Haemophilia or any other condition preventing the patient from having a liver biopsy, including anticoagulant therapy 8. Haemoglobinopathies (e.g. thalassaemia) 9. Evidence of advanced liver disease, such as history or presence of ascites, bleeding varices, encephalopathy 10. Patients with organ transplants 11. Any known pre-existing medical condition that could interfere with the patient’s participation in and completion of the protocol such as: 11.1. Pre-existing psychiatric condition (e.g. severe depression, or a history of severe psychiatric disorder) 11.2. CNS trauma or seizure disorder requiring medication 11.3. Significant cardiovascular dysfunction within the past 6 months (e.g. angina, congestive cardiac failure, recent myocardial infarction, severe hypertension or significant arrhythmia) 11.4. Patients with an ECG showing clinically significant abnormalities 11.5. Poorly controlled diabetes mellitus 11.6. Chronic pulmonary disease (e.g. chronic obstructive pulmonary disease) 11.7. Immunologically mediated disease (e.g. inflammatory bowel disease, Crohn’s disease, ulcerative colitis, rheumatoid arthritis, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune haemolytic anaemia, scleroderma, severe psoriasis, cryoglobulinaemia with vasculitis) 11.8. Any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids 11.9. Gout 12. Substance abuse, such as excessive alcohol intake (>50 g day–1) or erratic use of intravenous or inhaled drugs 13. Patients with clinically significant retinal abnormalities 14. Any other condition which in the opinion of the investigator would make the patient unsuitable for enrolment or that could interfere with the patient participating in or completing the protocol |
| Anticipated start date | 01/08/1998 |
| Anticipated end date | 31/10/2003 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 204 |
| Interventions |
Please note that, as of 14 January 2008, the anticipated end date of this trial has been updated from 31 July 2001 to 31 October 2003.
Interventions: 1. Interferon and ribavarin 2. No treatment |
| Primary outcome measure(s) |
Primary outcome measure updated as of 24/07/2007:
Sustained Virological Response (SVR) at 24 weeks post-treatment. Primary outcome measure provided at time of registration: Analysis includes health economics, quality of life and virological end points. |
| Secondary outcome measure(s) |
Secondary outcome measures added as of 24/07/2007:
1. Baseline factors predicting SVR 2. Changes in histopathology 3. Health-Related Quality of Life (HRQoL) 4. Viral kinetics: the relationship of early viral kinetics to final treatment outcome 5. Adverse events |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Trial website | |
| Publications |
2006 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/16750059
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| Contact name | Prof Howard Thomas |
| Address |
Department of Medicine
St Mary's Hospital Imperial College School of Medicine at St Mary's 10th Floor QEQM Wing South Wharf Road |
| City/town | London |
| Zip/Postcode | W2 1PG |
| Country | United Kingdom |
| Tel | +44 (0)20 7886 6454 |
| Fax | +44 (0)20 7724 9369 |
| h.thomas@imperial.ac.uk | |
| Sponsor | Department of Health (UK) |
| Address |
Quarry House
Quarry Hill |
| City/town | Leeds |
| Zip/Postcode | LS2 7UE |
| Country | United Kingdom |
| Sheila.Greener@doh.gsi.gov.uk | |
| Sponsor website: | http://www.dh.gov.uk/en/index.htm |
| Date applied | 25/04/2003 |
| Last edited | 01/09/2009 |
| Date ISRCTN assigned | 25/04/2003 |
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