A phase IV open-label multicentre, international trial of response guided treatment with directly observed pegylated interferon alfa 2b and self-administered ribavirin for patients with chronic HCV genotype 2 or 3 infection and ongoing injection drug use. - ACTIVATE

The Kirby Institute0 个研究点目标入组 100 人开始时间: 2012年5月3日最近更新: 2018年3月26日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 100

研究概览入排标准研究者记录与标识符相似试验

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. Participants 18 years of age or older.
•2. Chronic HCV infection (HCV antibody and/or detectable HCV RNA in plasma = 6 months, and HCV RNA positive at screening).
•3. HCV genotype 2 or 3 infection.
•4. Active injection drug use (defined as injection drug use within the 12 weeks prior to consent).
•5. Compensated liver disease (Child-Pugh class A), where the following criteria must be met: a.INR< 1.8, b. No ascites (present or ever), c. No hepatic encephalopathy (present or ever) d. No bleeding varices (present or ever)
•6. Patients with biopsy proven or suspected (Fibroscan > 10KPa or clinical signs) cirrhosis or transition to cirrhosis must have an abdominal ultrasound, CT scan, or MRI scan without evidence of hepatocellular carcinoma and a serum AFP <100 ng/mL within 2 months prior to screening.
•7. Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug.
•8. All fertile males and females must be using effective contraception (as defined in protocol section 7.3) during treatment and during the 24 weeks after treatment end.
•9. Participants have voluntarily signed the informed consent form.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 90
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

排除标准

•1. Echocardiographic findings or a medical history suggesting current or previous endocardititis.
•2. Active bacterial or mycobacterial infection.
•3. Women with ongoing pregnancy or breast feeding.
•4. Interferon or ribavirin therapy at any previous time.
•5. Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) 6. Any investigational drug 7. HCV genotype 1, 4, 5, 6, or 7 infection.
•8. HIV infection (positive test at screening for anti-HIV Ab)
•9. Hepatitis B virus infection (positive test at screening for HBsAg)
•10. Evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures).
•11. History or other evidence of decompensated liver disease.
•12. Neutrophil count <1500 cells/mm3 or platelet count <90,000 cells/mm3 at screening.
•13. Serum creatinine level >1.5 x upper limit of normal at screening.
•14. Ongoing severe psychiatric disease, especially depression, as judged by the treating physician.
•15. Frequent drug use that is judged by the treating physician to compromise treatment safety.
•16. History of a severe seizure disorder or current anticonvulsant use.
•17. History of immunologically mediated disease, severe chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study.
•18. Thyroid dysfunction not adequately controlled (TSH and T4 levels out of normal range).
•19. Evidence of severe retinopathy (e.g. CMV retinitis, macular degeneration) or clinically relevant ophthalmological disorder due to diabetes mellitus or hypertension.
•20. Inability or unwillingness to provide informed consent or abide by the requirements of the study.
•21. Male partners of women who are pregnant.
•22. Hemoglobin <12 g/dL (<7.4 mmol/L) in women or <13 g/dL (<8.1 mmol/L) in men at screening.
•23. Any patient with an increased baseline risk for anemia (e.g. thalassemia, spherocytosis, history of GI bleeding, etc) or for whom anemia would be medically problematic.
•24. 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 hemoglobin by up to 4 g/dL (as may be seen with ribavirin therapy) would not be well-tolerated.

研究者

发起方

The Kirby Institute

相似试验

进行中（未招募）

1 期

A trial of shortened Hepatitis C infection treatment in people who have an early response to treatment.Chronic Hepatitis C genotype 2 and 3 infection.MedDRA version: 18.0Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations

EUCTR2010-024557-36-GBThe Kirby Institute100

进行中（未招募）

1 期

A trial of shortened Hepatitis C infection treatment in people who have an early response to treatment.Chronic Hepatitis C genotype 2 and 3 infection.MedDRA version: 15.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations

EUCTR2010-024557-36-DEThe Kirby Institute100

进行中（未招募）

1 期

A multicentre and international trial of a new treatment regimen containing paritaprevir/ritonavir, ombitasvir, dasabuvir with or without ribavirin for people with chronic hepatitis C virus genotype 1 infection and recent injection drug use or receiving opioid substitution therapy.Chronic hepatitis C virus genotype 1 infectionMedDRA version: 19.0 Level: LLT Classification code 10072844 Term: Hepatitis C virus genotype 1a positive System Organ Class: 100000004848MedDRA version: 19.0 Level: LLT Classification code 10072845 Term: Hepatitis C virus genotype 1b positive System Organ Class: 100000004848

EUCTR2015-003562-90-FRThe Kirby Institute - UNSW Australia100

进行中（未招募）

1 期

A Phase 4 Multi-center, Multi-national, Open-label, Randomized, Two Dose Level Study of Naglazyme (galsulfase) in Infants with Maroteaux-Lamy Syndrome (MPS VI) - N/AMucopolysaccharidosis Type VI (MPS VIMaroteaux-Lamy Syndrome)MedDRA version: 6.0Level: PTClassification code 10056892

EUCTR2005-003512-30-FRBioMarin Pharmaceutical Inc.4

进行中（未招募）

不适用

EUCTR2005-003512-30-PTBioMarin Pharmaceutical Inc4