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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

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ClinicalTrials.gov Identifier: NCT01083251
Recruitment Status : Unknown
Verified March 2010 by Ziv Hospital.
Recruitment status was:  Recruiting
First Posted : March 9, 2010
Last Update Posted : January 19, 2011
Sponsor:
Information provided by:
Ziv Hospital

Tracking Information
First Submitted Date  ICMJE March 3, 2010
First Posted Date  ICMJE March 9, 2010
Last Update Posted Date January 19, 2011
Study Start Date  ICMJE March 2010
Estimated Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2010)
  • treatment efficacy [ Time Frame: 120 weeks ]
    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 ]
    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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE The Beneficial Effect of Vitamin D Supplement to Peg Interferon Alpha 2a or to Telbivudine Monotherapy in Patients With Chronic HBV Viral Infection
Brief Summary

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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis B Virus
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 8, 2010)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2012
Estimated Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01083251
Other Study ID Numbers  ICMJE 004-10
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assy Nimer, Ziv medical center
Study Sponsor  ICMJE Ziv Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ziv Hospital
Verification Date March 2010

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