Status:
COMPLETED
KRN7000 in Chronic Hepatitis B
Lead Sponsor:
Foundation for Liver Research
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this trial is to determine the safety, tolerability and effectiveness of KRN7000 for chronic hepatitis B infection.
Detailed Description
KRN7000 is reported to inhibit HBV replication in HBV transgenic mice. Anti-viral effects of KRN7000 can be expected in HBV, as the compound is able to induce not only IFN-alpha/beta but also IFN-gamm...
Eligibility Criteria
Inclusion
- Chronic hepatitis B (confirmed by a liver biopsy performed within 3 years prior to the screenings visit and HBV DNA in serum \>10E5 copies/ml at the screenings visit).
- ALT \> 1.2 x ULN on two occasions documented within 8 weeks before initiation of treatment.
- Able and likely to attend regularly for treatment and follow-up.
- Written informed consent.
- Adequate contraception for males and females during treatment and follow-up (written confirmation).
Exclusion
- Patients with evidence of cirrhosis.
- Decompensated liver disease, as marked by: bilirubin greater than 20 micromol/L or serum albumin \<35 g/L or prothrombin time greater than 3 seconds prolonged or Quick test below 70% or history of bleeding esophageal varices, ascites or hepatic encephalopathy.
- Systemic IFN treatment, systemic antiviral agents, systemic corticosteroids, immune suppressive treatment or any investigational drug within 3 months of entry to this protocol.
- Patients with ALT levels greater than 10 times ULN will not be enrolled but may be followed until three consecutive determinations within 2 months are below this level.
- Pregnancy, or in women of child-bearing potential or in spouses of such women, inability to practice adequate contraception.
- Significant systemic or major illnesses other than liver disease, including congestive heart failure, ischemic heart disease, angina pectoris, cerebrovascular disease, renal failure (creatinine clearance less than 50 ml/min), organ transplantation, serious psychiatric disease or depression, anaphylactic disorder.
- Pre-existing severe cytopenia; Hb\<7 mmol/L, WBC \<3x10E9/L, Plt \<100x10E9/L, Lymphocyte \<0.5x10E9/L.
- Any history or presence of autoimmune disease.
- Evidence of hepatocellular carcinoma; alpha-fetoprotein (AFP) levels greater than 50 ng/ml and ultrasound (or other imaging study) within 6 months prior to the entry demonstrating a mass suggestive of liver cancer.
- Human immunodeficiency virus infection, as shown by presence of anti-HIV antibody.
- Patients with cerebroside metabolite abnormalities (e.g. Gaucher's disease).
- Other acquired or inherited causes of liver disease: hepatitis C, hepatitis D, alcoholic liver disease, obesity induced liver disease, drug related liver disease, auto-immune liver disease, Wilson's disease, hemochromatosis, alpha-1-antitrypsin deficiency.
- Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the study.
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00363155
Start Date
March 1 2003
End Date
July 1 2006
Last Update
August 15 2006
Active Locations (1)
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1
Erasmus MC, University Medical Center Rotterdam
Rotterdam, Netherlands, 3015GD