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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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Ziv Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ziv Hospital
ClinicalTrials.gov Identifier:
NCT01083251
First received: March 3, 2010
Last updated: January 17, 2011
Last verified: March 2010

March 3, 2010
January 17, 2011
March 2010
February 2012   (final data collection date for primary outcome measure)
  • treatment efficacy [ Time Frame: 120 weeks ] [ Designated as safety issue: No ]
    The primary end point will be sustained viral response which was defined as clearance of HBeAg from serum and HBV DNA less than 10,000 copies/mL (2000 IU/mL) at 6 months after treatment. HBsAg titre during treatment and at 6 months follow up will be measured also (ROCH or Abott Kit).
  • histologic response [ Time Frame: 120 WEEKS ] [ Designated as safety issue: No ]
    Another primary endpoint will be histologic response (reduction of at least two points without fibrosis worsening in the total score on the Histological Activity Index).
Same as current
Complete list of historical versions of study NCT01083251 on ClinicalTrials.gov Archive Site
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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
The Beneficial Effect of Vitamin D Supplement to Peg Interferon Alpha 2a or to Telbivudine Monotherapy in Patients With Chronic HBV Viral Infection

Abstract

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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Interventional
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Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis B Virus
  • Drug: Peginterferon + Vitamin D
    180 mcg/week + 400 IUX2/day
  • Drug: Peginterferon
    180 mcg/week
  • Drug: Sebivo
    Telbivudine 600 mg daily
  • Drug: entecavir+ vitamin d
    entecavir 1 mg daily+ vitamin d
  • Experimental: 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
    Intervention: Drug: Peginterferon + Vitamin D
  • Active Comparator: Peginterferon
    Intervention: Drug: Peginterferon
  • Active Comparator: Sebivo
    Nucleotide Analog Telbivudine 600 mg daily
    Intervention: Drug: Sebivo
  • Active Comparator: entecavir + vitamin d
    baraclude 1 mg x1/ day + vitamin d
    Intervention: Drug: entecavir+ vitamin d
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
December 2012
February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients were eligible if they had been HBsAg positive for at least 6 months,
  • 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:

  • decompensated liver disease,
  • 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.
Both
18 Years and older
No
Contact: Assy Nimer, MD +97246828445 ASSY.N@ZIV.HEALTH.GOV.IL
Israel
 
NCT01083251
004-10
Yes
Assy Nimer, Ziv medical center
Ziv Hospital
Not Provided
Not Provided
Ziv Hospital
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP