NCT00262379已完成3 期
Multicenter Study, Randomized and Pragmatic, Comparing Two Therapeutic Strategies : Use or Non-use of Epoetin Beta in Patients Infected by Chronic Hepatitis C and Treated by Combination Therapy Peginterferon Alfa-2a Plus Ribavirin
University Hospital, Angers37 个研究点 分布在 1 个国家目标入组 229 人开始时间: 2005年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 229
- 试验地点
- 37
- 主要终点
- Sustained Viral Response (Week 72)
研究概览
简要总结
The purpose is to demonstrate a correction of anemia in hepatitis C virus treatment with peginterferon plus ribavirin.
详细描述
Show that the correction of anemia by epoetin beta (NeoRecormon®) able to maintain a optimal dose of ribavirin (Copegus®). The study compares two therapeutic strategies : use or non-use of epoetin beta (NeoRecormon®) in patients infected by chronic hepatitis C and treated by combination therapy Peginterferon alfa-2a (Pegasys®) plus ribavirin (Copegus®). The main judgement criteria are :
- Sustained Viral Response (Week 72)
- Viral Response at the End of Treatment (Week 48)
- Quality of life
- Cumulative dose of ribavirin from D0-W24 and from W24-W48 periods
- Clinical and biological tolerance
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients 18 years old or above
- •Patient with French social security or other equivalent health assurance
- •Patient with informed consent
- •Serologic evidence of chronic hepatitis C by detectable anti-HCV antibodies
- •Patient infected by HCV genotype 1, 4, 5 or 6
- •Compensated liver disease (Child-Pugh ≤ 6)
- •Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior the enrollment in the study
- •All fertile males and females receiving ribavirin must have effective contraception during treatment and during the 6 following months
- •Patient naive of treatment with installation of treatment by investigator following criteria for use Peginterferon alfa-2a (Pegasys) and ribavirin (Copegus)
排除标准
- •Women with ongoing pregnancy or breast feeding
- •Male partner of pregnancy woman
- •Major protected by French law for biomedical study
- •Co-infection by HBV or HIV
- •History or other evidence of decompensated liver disease or Child-Pugh score > 6
- •Clinical or radiological evidence (abdominal ultrasound, CT scan or MRI) of hepatocellular carcinoma
- •IFN or ribavirin at any previous time
- •Patient who received an erythropoetin within 2 months before inclusion
- •History of epilepsy (during the last 6 months)
- •Chronic cardiac insufficiency (stage III or IV in classification from the New York Heart Association [NYHA])
- •Not controlled portal hypertension
- •Antecedents or risk of venous thrombosis
- •Surgery within 3 months before inclusion
- •Serum creatinine level >15 mg/mL (130µmol/L)
- •Deficiency in vitamin B9 and/or B12 (suspected with macrocytosis > 105 µm3)
- •Thrombocytosis (platelets > 500 000/mm3)
- •Chronic inflammatory syndrome (CRP > 10 mg/L)
- •Deficiency not corrected in iron :
- •Ferritin blood level < 10 µg/L Or - Transferrin saturation coefficient < 20 %
- •History of neoplasia (except basocellular epithelioma and cervical cancer)
- •Contraindications to use epoetin beta or an excipient from molecule to study (urea, polysorbate 20, glycine, leucine, isoleucine, threonine, glutamic acid, phenylalanine, benzoic acid, benzyl alcohol)
- •Absence of written informed consent
- •Exclusion time for another biomedical study
- •Patient with blood concentration of hemoglobin lower or equal to 12 g/dL for male or lower or equal to 11 g/dL for female
研究组 & 干预措施
Groupb
Active Comparator
HCV treatment with peginterferon plus ribavirin during 48 weeks plus epoetin beta under anemia conditions
干预措施: epoetin beta (NeoRecormon®) (Drug)
结局指标
主要结局
Sustained Viral Response (Week 72)
时间窗: Week 72
Actual Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values up to Week 24 in the Post-treatment Follow-up Period
次要结局
- • Quality of life(D0, W4, W12, W24, W48, W72)
- • Cumulative dose of ribavirin from D0-W24 and from W24-W48 periods(D0, W4, W8, W12, W16, W20, W24, W28, W32, W36, W40, W44, W48)
- • Viral Response at the End of Treatment (Week 48)(Week 48)
- • Clinical and biological tolerance(D0, W4, W8, W12, W16, W20, W24, W28, W32, W36, W40, W44, W48, W52, W60, W72)
研究者
研究点 (37)
Loading locations...
相似试验
已完成
2 期
High-Dose Ribavirin and Peginterferon to Treat Chronic Hepatitis C Genotype 1Chronic Hepatitis CNCT00735969National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)21
已完成
2 期
Effect of Low-dose PegIntron on ALT Normalization in Japanese Patients With Chronic Hepatitis C (Study P04508)(COMPLETED)Hepatitis C, ChronicHepatitis CNCT00787371Merck Sharp & Dohme LLC69
已完成
4 期
Individualized Duration of Peg-interferon/Ribavirin Treatment of Hepatitis CChronic Hepatitis C, Genotype 1NCT00910975Göteborg University100
已完成
3 期
Open Label Trial of PEG-IFN, RBV & TVR vs. PEG-IFN & RBV Alone in Tx of HCV-1 in HIV-1 Co-infected Patients (CHAT)HIVNCT02006745St Stephens Aids Trust20
招募中
2 期
Perioperative Vitamin C to Reduce Persistent Pain After Total Knee ArthroplastyChronic PainKnee Pain ChronicPost Operative PainNCT06123715University Health Network, Toronto400