The Beneficial Effect of Vitamin D Supplement to Peg Interferon Alpha 2a or to Telbivudine Monotherapy in Patients With Chronic Hepatitis B Virus (HBV) Infection
NCT ID: NCT01083251
Last Updated: 2011-01-19
Study Results
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Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2010-03-31
2012-12-31
Brief Summary
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Telbivudine is a potent inhibitor of HBV but, due to a low genetic barrier to resistance, a high incidence of resistance has been observed in patients with high baseline levels of replication and in those with detectable HBV DNA after 24 weeks of therapy (A1). Telbivudine might be used in patients with good predictors of response (HBV DNA \<2 X 106 IU/ ml, i.e. approximately 107 copies/ ml, or 6.3 log 10 IU/ ml at baseline) with verification of HBV DNA suppression below detection in real time PCR assay at 24 weeks.(EASL Guidelines for HBV 2009) The therapy of Pegylated-interferon-alpha-2a is considered as the standard of care for patients with chronic hepatitis b viral infection. However, recent study by Buster et al showed that a sustained viral response (SVR less than 2000 iu.ml at 6 months after treatment)) is obtained in 8 % of patients with genotype D, 30% genotype A, and 20-25% genotypes B or C (47). Vitamin D is a potent immune-modulator; and has been shown to improve SVR in combination with peg interferone in patients with chronic HCV viral infection (48). The impact of vitamin D on virologic response rates of interferon-based treatment of CHB is unknown. The aim of this study therefore was to assess whether Vitamin D, added to the conventional peg therapy in CHB, or to nucleotide analogues could improve the treatment efficacy
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Peg + Vitamin D
Treatment arm with vitamin D will be treated first with vitamin D supplement for 3 months before the initiation of antiviral therapy. Vitamin D levels will be measures at baseline and three months after. The serum vitamin D-25-OH levels should be \> 32 ng/ml before the initiation of antiviral treatment). HBV DNA levels will be also measure at baseline and after 3 months of mono therapy with vitamin D
Peginterferon + Vitamin D
180 mcg/week + 400 IUX2/day
Peginterferon
Peginterferon
180 mcg/week
Sebivo
Nucleotide Analog Telbivudine 600 mg daily
Sebivo
Telbivudine 600 mg daily
entecavir + vitamin d
baraclude 1 mg x1/ day + vitamin d
entecavir+ vitamin d
entecavir 1 mg daily+ vitamin d
Interventions
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Peginterferon + Vitamin D
180 mcg/week + 400 IUX2/day
Peginterferon
180 mcg/week
Sebivo
Telbivudine 600 mg daily
entecavir+ vitamin d
entecavir 1 mg daily+ vitamin d
Eligibility Criteria
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Inclusion Criteria
* patients were HBeAg positive or negative,
* patients had increased serum ALT levels between 1 and 10 times the upper limit of normal (ULN),
* patients had serum HBV-DNA levels greater than 1.0 x 10E5 copies/mL (2.0 X 10E4 IUmL), and
* patients had findings on a liver biopsy within the preceding 12 months that were consistent with the presence of chronic hepatitis B.
Exclusion Criteria
* antiviral therapy within 6 months before randomization,
* viral co-infections (hepatitis C virus, hepatitis delta virus, or human immunodeficiency virus), or
* pre-existent neutropenia or thrombocytopenia.
18 Years
ALL
No
Sponsors
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Ziv Hospital
OTHER_GOV
Responsible Party
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Ziv medical center
Locations
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Liver clinic
Safed, , Israel
Ziv medical center liver unit
Safed, Israel, , Israel
Countries
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Central Contacts
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Facility Contacts
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nimer assy, MD
Role: primary
Other Identifiers
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004-10
Identifier Type: -
Identifier Source: org_study_id
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