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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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Information provided by:
Ziv Hospital

Brief Summary:


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

Condition or disease Intervention/treatment Phase
Hepatitis B Virus Drug: Peginterferon + Vitamin D Drug: Peginterferon Drug: Sebivo Drug: entecavir+ vitamin d Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Beneficial Effect of Vitamin D Supplement to Peg Interferon Alpha 2a or to Telbivudine Monotherapy in Patients With Chronic HBV Viral Infection
Study Start Date : March 2010
Estimated Primary Completion Date : February 2012
Estimated Study Completion Date : December 2012

Arm Intervention/treatment
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
Drug: Peginterferon + Vitamin D
180 mcg/week + 400 IUX2/day

Active Comparator: Peginterferon Drug: Peginterferon
180 mcg/week

Active Comparator: Sebivo
Nucleotide Analog Telbivudine 600 mg daily
Drug: Sebivo
Telbivudine 600 mg daily

Active Comparator: entecavir + vitamin d
baraclude 1 mg x1/ day + vitamin d
Drug: entecavir+ vitamin d
entecavir 1 mg daily+ vitamin d

Primary Outcome Measures :
  1. 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).

  2. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01083251

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Contact: Assy Nimer, MD +97246828445 ASSY.N@ZIV.HEALTH.GOV.IL

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Ziv medical center liver unit Not yet recruiting
Safed, Israel, Israel, 13100
Liver clinic Recruiting
Safed, Israel, 13100
Contact: nimer assy, MD         
Sponsors and Collaborators
Ziv Hospital
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Responsible Party: Assy Nimer, Ziv medical center
ClinicalTrials.gov Identifier: NCT01083251    
Other Study ID Numbers: 004-10
First Posted: March 9, 2010    Key Record Dates
Last Update Posted: January 19, 2011
Last Verified: March 2010
Keywords provided by Ziv Hospital:
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections
Vitamin D
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Antiviral Agents
Anti-Infective Agents