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
  Purpose

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


Condition Intervention
Hepatitis B Virus
Drug: Peginterferon + Vitamin D
Drug: Peginterferon
Drug: Sebivo
Drug: entecavir+ vitamin d

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Ziv Hospital:

Primary Outcome Measures:
  • 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).


Estimated Enrollment: 120
Study Start Date: March 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01083251

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

Locations
Israel
Liver clinic Recruiting
Safed, Israel, 13100
Contact: nimer assy, MD         
Ziv medical center liver unit Not yet recruiting
Safed, Israel, Israel, 13100
Sponsors and Collaborators
Ziv Hospital
  More Information

No publications provided

Responsible Party: Assy Nimer, Ziv medical center
ClinicalTrials.gov Identifier: NCT01083251     History of Changes
Other Study ID Numbers: 004-10
Study First Received: March 3, 2010
Last Updated: January 17, 2011
Health Authority: Israel: Ethics Commission

Keywords provided by Ziv Hospital:
HBV
VITAMIN D
PEGITERFERON
Telbivudine

Additional relevant MeSH terms:
Vitamin D
Ergocalciferols
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic
Interferon-alpha
Interferon Alfa-2a
Interferons
Peginterferon alfa-2a
Entecavir
Vitamins
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on July 22, 2014