KRN7000 in Chronic Hepatitis B

NCT00363155 | Completed Phase 1

• 1 other identifier: KRN7000/02-B01
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to determine the safety, tolerability and effectiveness of KRN7000 for chronic hepatitis B infection.

Conditions

Hepatitis B, Chronic

Keywords

chronic; hepatitis b

Outcome Measures

Primary Outcomes (1)

• To determine safety and tolerability

Secondary Outcomes (3)

• To evaluate effectiveness in reducing HBV DNA load

• To evaluate effectiveness in inducing immunological responses

• TO evaluate effectiveness in normalization of ALT

Interventions

KRN7000 DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Foundation for Liver Research: lead

Study Sites (1)

Erasmus MC, University Medical Center Rotterdam

Rotterdam, 3015GD, Netherlands

Location

MeSH Terms

Conditions

Hepatitis B, Chronic; Bronchiolitis Obliterans Syndrome; Hepatitis B

Interventions

KRN 7000

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Harry LA Janssen, MD, PhD

  Dept. of Gastroenterology & Hepatology, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 10, 2006
• First Posted: August 15, 2006
• Study Start: March 1, 2003
• Study Completion: July 1, 2006
• Last Updated: August 15, 2006

Record last verified: 2006-08

Locations

NL (1)