Lamivudine for Chronic Hepatitis B

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00001457
• Date of registration: 03/11/1999
• Prospective Registration: No
• Primary sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Public title: Lamivudine for Chronic Hepatitis B
• Scientific title: Lamivudine for Chronic Hepatitis B
• Date of first enrolment: September 1995
• Target sample size: 60
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00001457
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Key inclusion & exclusion criteria

INCLUSION CRITERIA

Age 18 years or above, male or female.

Known presence of HBsAg in serum for at least 6 months.

Liver biopsy histology showing chronic hepatitis with or without cirrhosis.

Previous therapy with alpha interferon without a lasting effect or intolerance to alpha
interferon, due to side effects.

Written informed consent.

Group A: For patients with chronic hepatitis B with atypical serology: absence of HBeAg
from serum despite elevations in serum aminotransferases, such as that the average levels
are greater than 55 U/L (approximately 1.3 times the upper limit of the normal range)
based upon two determinations taken at least one month apart during the 6 months before
entry.

Group B: For patients with glomerulonephritis: proteinuria of greater than 1 gm per 24
hours. For patients with polyarteritis, radiological proof of arteritis and involvement
of at least on organ system outside of the liver.

Group C: For patients with chronic delta hepatitis: anti-HDV in serum and HDV antigen in
liver biopsy or HDV RNA in serum and elevations in serum aminotransferases, such that the
average levels are greater than 55 U/L based upon two determinations taken at least one
month apart during the 6 months before entry.

Group D: For patients with chronic hepatitis B and typical serology: HBeAg and HBV DNA in
serum but ineligibility to enter the multicenter trial of lamivudine either because of
previous receipt of interferon and intolerable side effects, refusal to receive interferon
again, because of normal serum aminotransferases, or lack of availability of the trial.

EXCLUSION CRITERIA

Pregnant or if capable of bearing or fathering children must practice adequate
contraception.

Significant systemic illnesses other than liver diseases, including congestive heart
failure, renal failure, chronic pancreatitis, diabetes mellitus with poor control.

Pre-existing bone marrow compromise: hematocrit must be greater than 30%, white blood
cell count must be greater than 2000 mm(3), platelets must be greater than 70,000 mm(3).

Creatinine clearance must be greater than 50 cc/min.

A history of clinically apparent pancreatitis or evidence of subclinically pancreatitis as
shown by serum amylase values twice the upper limits of the normal range and abnormalities
of the pancreas on computerized tomography or other imaging studies of the abdomen.

Irreversibly severe cirrhosis as defined by Child's stage C.

Presence of anti-HIV or anti-HCV with HCV RNA in serum.

Immunosuppressive therapy requiring use of more than 10 mg of prednisone (or its
equivalent) per day.

Other antiviral therapy for chronic hepatitis B within the previous 3 months.

Sensory or motor neuropathy apparent from medical history and physical examination.



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Hepatitis B

Chronic Hepatitis D

Glomerulonephritis

Polyarteritis Nodosa

Intervention(s)

Drug: Lamivudine

Secondary ID(s)

95-DK-0199

950199

Source(s) of Monetary Support

Please refer to primary and secondary sponsors