Different Regimens of Pegylated Interferon and Lamivudine Combination Therapy in Chronic Hepatitis B Patients
NCT ID: NCT00226447
Last Updated: 2008-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2002-12-31
2006-07-31
Brief Summary
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Detailed Description
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Previous studies on IFN-alfa and lamivudine combination treatment of chronic hepatitis B showed marginal benefit over lamivudine monotherapy. In these studies, lamivudine was either started 8 weeks prior to IFN-alfa or simultaneous with IFN-alfa. Recently, we have performed a study comparing the efficacy of polyethylene glycol-interferon alfa-2b (PEG-Intron A) and lamivudine versus lamivudine monotherapy for 1 year in the treatment of chronic hepatitis B. In our protocol, PEG-Intron A is started 8 weeks before the commencement of lamivudine, and PEG-Intron A is given for 32 weeks while lamivudine is given for a total of 52 weeks. Our published results suggested PEG-Intron A and lamivudine combination treatment is far superior to lamivudine monotherapy (end of treatment virological response 92% vs 20%, p=0.0015). We are not certain whether the benefit of PEG-Intron A and lamivudine combination in our study is due to our staggered regime, the superiority of PEG-Intron A over IFN-alfa, or both. The aim of this study is to investigate the best treatment regime of PEG-Intron A and lamivudine combination in terms of viral clearance.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Pegylated Interferon
Lamivudine
Eligibility Criteria
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Inclusion Criteria
* 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
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
Exclusion Criteria
* Written informed consent
* 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
18 Years
65 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
GlaxoSmithKline
INDUSTRY
Chinese University of Hong Kong
OTHER
Responsible Party
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Chinese University of Hong Kong
Principal Investigators
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Henry LY Chan, MD
Role: PRINCIPAL_INVESTIGATOR
Chinese University of Hong Kong
Locations
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Cheng Suen Man Shook Hepatitis Center, Institute of Digestive Disease, The Chinese University of Hong Kong, Prince of Wales Hospital
Hong Kong SAR, , China
Countries
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References
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Lok AS, Wu PC, Lai CL, Lau JY, Leung EK, Wong LS, Ma OC, Lauder IJ, Ng CP, Chung HT. A controlled trial of interferon with or without prednisone priming for chronic hepatitis B. Gastroenterology. 1992 Jun;102(6):2091-7. doi: 10.1016/0016-5085(92)90337-x.
Lai CL, Chien RN, Leung NW, Chang TT, Guan R, Tai DI, Ng KY, Wu PC, Dent JC, Barber J, Stephenson SL, Gray DF. A one-year trial of lamivudine for chronic hepatitis B. Asia Hepatitis Lamivudine Study Group. N Engl J Med. 1998 Jul 9;339(2):61-8. doi: 10.1056/NEJM199807093390201.
Leung NW, Lai CL, Chang TT, Guan R, Lee CM, Ng KY, Lim SG, Wu PC, Dent JC, Edmundson S, Condreay LD, Chien RN; Asia Hepatitis Lamivudine Study Group. Extended lamivudine treatment in patients with chronic hepatitis B enhances hepatitis B e antigen seroconversion rates: results after 3 years of therapy. Hepatology. 2001 Jun;33(6):1527-32. doi: 10.1053/jhep.2001.25084.
Schalm SW, Heathcote J, Cianciara J, Farrell G, Sherman M, Willems B, Dhillon A, Moorat A, Barber J, Gray DF. Lamivudine and alpha interferon combination treatment of patients with chronic hepatitis B infection: a randomised trial. Gut. 2000 Apr;46(4):562-8. doi: 10.1136/gut.46.4.562.
Barbaro G, Zechini F, Pellicelli AM, Francavilla R, Scotto G, Bacca D, Bruno M, Babudieri S, Annese M, Matarazzo F, Di Stefano G, Barbarini G; Lamivudine Italian Study Group Investigators. Long-term efficacy of interferon alpha-2b and lamivudine in combination compared to lamivudine monotherapy in patients with chronic hepatitis B. An Italian multicenter, randomized trial. J Hepatol. 2001 Sep;35(3):406-11. doi: 10.1016/s0168-8278(01)00145-3.
Tsiang M, Rooney JF, Toole JJ, Gibbs CS. Biphasic clearance kinetics of hepatitis B virus from patients during adefovir dipivoxil therapy. Hepatology. 1999 Jun;29(6):1863-9. doi: 10.1002/hep.510290626.
Other Identifiers
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P03227
Identifier Type: -
Identifier Source: org_study_id