KRN7000 in Chronic Hepatitis B

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00363155
• Date of registration: 10/08/2006
• Prospective Registration: No
• Primary sponsor: Foundation for Liver Research
• Public title: KRN7000 in Chronic Hepatitis B
• Scientific title: Phase I/II Trial of KRN7000 in Patients With Chronic Hepatitis B Infection
• Date of first enrolment: March 2003
• Target sample size: 28
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00363155
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

Netherlands

Contacts

• Name: Harry LA Janssen, MD, PhD
• Affiliation: Dept. of Gastroenterology & Hepatology, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Hepatitis B, Chronic

Intervention(s)

Drug: KRN7000

Primary Outcome(s)

To determine safety and tolerability

Secondary Outcome(s)

To evaluate effectiveness in inducing immunological responses

To evaluate effectiveness in reducing HBV DNA load

TO evaluate effectiveness in normalization of ALT

Secondary ID(s)

KRN7000/02-B01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors