EUCTR2009-011786-80-FR进行中（未招募）1 期
Randomized, Controlled Phase 2a/b Study of the Efficacy and Safety of PEG-rIL-29Administered in Combination with Ribavirin to Treatment-Naive Subjects with ChronicHepatitis C Virus Infection
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Males or females between the ages of 18 and 70 years, inclusive, at the time of
- •signing informed consent
- •2. No prior therapy for chronic HCV, other than up to 2 weeks of single-agent therapy
- •with a direct-acting antiviral agent, including but not limited to, a protease or
- •polymerase inhibitor
- •3. Genotype 1, 2, 3, or 4 HCV RNA. Mixed genotype HCV infection is not allowed
- •4. HCV RNA =100,000 IU/mL
- •5. ALT and AST =5.0 × ULN
- •6. Documented absence of cirrhosis, with the exception of approximately 10 subjects in
- •each treatment group in Phase 2b. Subjects with cirrhosis must not have decompensated liver disease. For subjects without cirrhosis, absence of cirrhosis must be documented as follows: genotype 1 and 4 subjects must have a documented liver biopsy performed =2 years before study randomization. Genotype 2 and 3 subjects must have either a documented liver biopsy performed =2 years before study randomization or a FibroTest performed during the screening period. Subjects without cirrhosis must have a documented liver biopsy with an Ishak score =4 or Metavir fibrosis score =3 (genotypes 1, 2, 3 or 4), or a FibroTest = 0.72 (genotype 2 or 3)
- •7. No prior history of hepatocellular carcinoma at any time, nor evidence of
- •hepatocellular carcinoma documented by abdominal imaging (e.g., ultrasound),
- •within 12 months of study randomization; imaging may be performed during
- •screening period.
- •8. Alpha-fetoprotein <100 ng/mL
- •9. ECG with no clinically significant abnormalities at the time of screening as deemed
- •by the investigator
- •10. Platelet count =90,000/mm3; ANC =1500/mm3; hemoglobin (Hgb) =12 g/dL (males)
- •or =11 g/dL (females)
- •11. PTT =1.5 × ULN; fibrinogen = lower limit of normal
- •12. Creatinine clearance =50 mL/min calculated according to the Cockcroft-Gault
- •13. Thyroid-stimulating hormone (TSH) and/or T4 within 0.8 to 1.2 times the normal
- •limit, or adequately controlled thyroid function as assessed by the investigator
- •14. Documented baseline retinal exam performed =1 year of study randomization. For
- •subjects with diabetes, hypertension, or other risk factors for retinal disease per
- •assessment of the investigator, the exam should be performed by an ophthalmologist; may be performed during screening period
- •15. Able to comprehend the investigational nature of this study and sign an institutional review board (IRB)/independent ethics committee (IEC)-approved informed
- •consent form
- •16. If female and of child-bearing potential, has a negative serum pregnancy test at
- •screening and a negative serum or urine pregnancy test within 72 hours before
- •initial study drug treatment. For the purpose of this study, a female subject should
- •be considered of childbearing potential unless she is documented as surgically
- •sterile (i.e., by hysterectomy, bilateral oophorectomy, or medically documented
- •ovarian failure), postmenopausal for at least 2 years, or if postmenopausal for =2
- •years, has follicle-stimulating hormone (FSH) >35 mIU/mL.
- •17. If male, or female of child-bearing potential must agree to utilize 2 separate forms of contraception, one of which must be an effective barrier method (or be nonheterosexually active or have a vasectomized partner) from the time of signing
- •informed consent until 6 months after the last dose of ribavirin. Medically
- •accepted contraception methods include intrauterine device; barrier methods, such
- •as diaphragm, condom, cap or sponge, used with a spermicide; or hormonal
- •contraception. Female subjects who use hormonal contra
排除标准
- •1. Mixed genotype HCV infection
- •2. Current or prior history of decompensated liver disease, including any of the
- •following: current or prior history of encephalopathy of any grade, current or
- •prior history of variceal bleeding, current or prior history of ascites, total serum bilirubin >1.5 mg/dL (unless due to Gilbert’s disease), albumin <3.5 g/dL, or INR >1.2
- •3. Currently lactating or breast-feeding
- •4. Has a female partner who is pregnant
- •5. Received any investigational drug, including a direct-acting antiviral agent, within
- •60 days prior to receiving study drug
- •6. Current or known history of cancer (except adequately treated in situ carcinoma
- •of the cervix, or basal or squamous cell carcinoma of the skin) within 5 years
- •prior to enrollment
- •7. Current systemic use of immunosuppressive medications, including corticosteroids
- •8. Current use of heparin or coumadin
- •9. Positive test for hepatitis B surface antigen, human immunodeficiency virus
- •(HIV)-1, or HIV2 antibody at screening
- •10. Active substance abuse, such as alcohol, or inhaled or injected drugs, within 6
- •months before signing informed consent. Subjects who are receiving methadone
- •or other substitutive product under medical supervision are eligible. Use of
- •marijuana for medical purposes is allowed.
- •11. Received blood products within 30 days prior to study randomization
- •12. Use of hematologic growth factors within 90 days prior to study randomization
- •13. Prior or current history of cardiomyopathy or significant ischemic cardiac or
- •cerebrovascular disease, including history of angina, myocardial infarction, or
- •cerebrovascular accident, within 12 months of study enrollment
- •14. Prior or current history of clinically significant hemoglobinopathy or hemolytic
- •15. Prior history of clinically significant liver disease other than chronic hepatitis C
- •16. Prior or current history of interstitial lung disease or sarcoidosis
- •17. History of organ transplant; prior corneal transplant is permitted
- •18. History of immunologically mediated disease (including, but not limited to,
- •rheumatoid arthritis, inflammatory bowel disease, moderate to severe psoriasis
- •[mild psoriasis is allowed], sarcoidosis, and systemic lupus erythematosus)
- •19. History of moderate, severe, or uncontrolled psychiatric disease; mild depression
- •controlled at time of study entry is allowed
- •20. Active seizure disorder. Subjects with a seizure history on anti-seizure
- •medication and with no seizure during the year prior to signing informed consent
- •are allowed
- •21. Any other known contraindication to peginterferon alfa-2a or ribavirin therapy
- •22. Systemic antibiotics, antifungals, or antivirals for treatment of active infection
- •within 14 days of enrollment
- •23. Currently on dialysis, including hemodialysis or peritoneal dialysis
- •24. Has, in the opinion of the investigator, any physical exam findings, laboratory
- •abnormalities, or other medical, social, or psychosocial factors that may
- •negatively impact compliance or subject’s safety by participation in this study
研究者
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