ISRCTN24461054已完成未知
Health benefits from anti-viral therapy for mild chronic hepatitis C
Department of Health (UK)0 个研究点目标入组 204 人开始时间: 2003年4月25日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 204
研究概览
简要总结
2006 Results article in http://www.ncbi.nlm.nih.gov/pubmed/16750059 HTA monograph
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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