Status:
COMPLETED
Different Regimens of Pegylated Interferon and Lamivudine Combination Therapy in Chronic Hepatitis B Patients
Lead Sponsor:
Chinese University of Hong Kong
Collaborating Sponsors:
Hoffmann-La Roche
GlaxoSmithKline
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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.
Detailed Description
Chronic hepatitis B is a major cause of mortality and morbidity in Hong Kong and most Southeast Asian countries. The efficacy interferon-alfa (IFN-alfa) or lamivudine monotherapy is far from satisfact...
Eligibility Criteria
Inclusion
- 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:
- Hemoglobin within range \& not less than 10% from lower normal limit
- WBC \>= 4,000/mm3
- Platelets \>= 100,000/mm3
- Bilirubin normal (except for Gilbert's disease).
- 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
- Co-infection with hepatitis C virus and/or HIV
- Evidence or history of decompensated liver disease
- Child's B cirrhosis
- Ascites, bleeding varices, spontaneous encephalopathy
- Hypersplenism (hemoglobin, white cell count, platelet outside inclusion criteria)
- 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
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00226447
Start Date
December 1 2002
End Date
July 1 2006
Last Update
October 24 2008
Active Locations (1)
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1
Cheng Suen Man Shook Hepatitis Center, Institute of Digestive Disease, The Chinese University of Hong Kong, Prince of Wales Hospital
Hong Kong SAR, China