Hepatitis B, Chronic Clinical Trial
Official title:
Phase I/II Trial of KRN7000 in Patients With Chronic Hepatitis B Infection
The purpose of this trial is to determine the safety, tolerability and effectiveness of KRN7000 for chronic hepatitis B infection.
Status | Completed |
Enrollment | 28 |
Est. completion date | July 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | Erasmus MC, University Medical Center Rotterdam | Rotterdam |
Lead Sponsor | Collaborator |
---|---|
Foundation for Liver Research |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine safety and tolerability | |||
Secondary | To evaluate effectiveness in reducing HBV DNA load | |||
Secondary | To evaluate effectiveness in inducing immunological responses | |||
Secondary | TO evaluate effectiveness in normalization of ALT |
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