Different Regimens of Pegylated Interferon and Lamivudine Combination Therapy in Chronic Hepatitis B Patients

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim is to investigate the best treatment regime of PEG-Intron A and lamivudine combination in terms of viral clearance in chronic hepatitis B patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong
• Collaborators: GlaxoSmithKline; Hoffmann-La Roche
• Treatments: Interferons; Lamivudine

Criteria

Inclusion Criteria:

• HBsAg positive for at least 6 months prior to screening

• Serum HBV-DNA > 10^6 copies per ml at screening

• Serum HBeAg positive at screening

• Abnormal ALT (1.3-10x upper limit normal) within one month prior to entry

• Compensated liver disease with the following minimum criteria:

1. Hemoglobin within range & not less than 10% from lower normal limit

2. WBC >= 4,000/mm3

3. Platelets >= 100,000/mm3

4. Bilirubin normal (except for Gilbert's disease).

5. Albumin stable and normal

• Serum creatinine normal or not more than 10% above the upper normal limit

• Thyroid Stimulating Hormone (TSH) within normal limits (Patients requiring medication to maintain TSH levels in the normal range are eligible if all other inclusion/exclusion criteria are met.)

• Alfa-fetoprotein in normal range (obtained within the previous year, or if elevated and < 500 ng/ml with a negative ultrasound for hepatocellular carcinoma at screening).

• Written informed consent

Exclusion Criteria:

• Co-infection with hepatitis C virus and/or HIV

• Evidence or history of decompensated liver disease

1. Child's B cirrhosis

2. Ascites, bleeding varices, spontaneous encephalopathy

3. Hypersplenism (hemoglobin, white cell count, platelet outside inclusion criteria)

4. Coagulopathy (PT > 13 sec)

• Any known pre-existing medical condition that could interfere with the patient's participation in and completion of the treatment such as:

• Pre-existing psychiatric condition, especially severe depression, or a history of severe psychiatric disorder.

• Patients on anti-depressant therapy are excluded

• CNS trauma or active seizure disorders requiring medication

• Poorly controlled diabetes mellitus

• Immunologically mediated disease (e.g., inflammatory bowel disease (Crohn's disease, ulcerative colitis, idiopathic thrombocytopenic purpura, lupus erythematous, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis).

• Clinical gout

• ANA > 1:320

• documentation that women of childbearing potential are using contraception. A serum pregnancy test obtained within two weeks prior to initiation of treatment must be negative. Female patients must not be breast feeding.

• Any known history of hypersensitivity to nucleoside analogues or interferon

• Previous use of interferon, lamivudine, immunosuppressive drugs or corticosteroid

• Subjects with clinically significant retinal abnormality

• Substance abuse, such as alcohol (>80 g/day), iv drugs and inhaled drugs. If the subject has a history of substance abuse, to be considered for inclusion into the protocol, the subject must have abstained from using the abused substance for at least 2 years. Subjects receiving methadone within the past 2 years are also excluded.

• Subjects not willing to be counseled/abstain from the consumption of alcohol