A trial of shortened Hepatitis C infection treatment in people who have an early response to treatment.

Phase 1

• Conditions: Chronic Hepatitis C genotype 2 and 3 infection.; MedDRA version: 18.0Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2010-024557-36-GB
• Lead Sponsor: The Kirby Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-23
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

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 detectable HCV RNA at screening).
3. HCV genotype 2 or 3 infection.
4. Active injection drug use (defined as injection drug use within the 24 weeks prior to consent) OR currently receiving opiate substitution therapy.
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 (see 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 months prior to the first dose of study drug.
6. Any investigational drug ?6 weeks prior to the first dose of study 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 =100,000 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified