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Clinical Trials/EUCTR2010-024557-36-DE
EUCTR2010-024557-36-DEActive, not recruitingPhase 1

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 sites100 target enrollmentStarted: January 23, 2013Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
100
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •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 28 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

Exclusion Criteria

  • •1. Echocardiographic findings or a medical history suggesting current or previous endocardititis. Baseline 12-lead ECG suggesting a contraindication to treatment with pegylated interferon alfa 2b and ribavirin.
  • •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. Platelet count prior to commencing therapy with pegylated interferon alfa 2b and ribavirin > 100,000/ mm3
  • •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.

Investigators

Sponsor
The Kirby Institute

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