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

NCT01083251 | Unknown DMC

• 1 other identifier: 004-10
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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

Conditions

Hepatitis B Virus

Keywords

HBV; VITAMIN D; PEGITERFERON; Telbivudine

Outcome Measures

Primary Outcomes (2)

• treatment efficacy

  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).

  120 weeks

• histologic response

  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).

  120 WEEKS

Study Arms (4)

Peg + Vitamin D

EXPERIMENTAL

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

Peginterferon

ACTIVE COMPARATOR

Drug: Peginterferon

Sebivo

ACTIVE COMPARATOR

Nucleotide Analog Telbivudine 600 mg daily

Drug: Sebivo

entecavir + vitamin d

ACTIVE COMPARATOR

baraclude 1 mg x1/ day + vitamin d

Drug: entecavir+ vitamin d

Interventions

Peginterferon + Vitamin D DRUG

180 mcg/week + 400 IUX2/day

Peg + Vitamin D

Peginterferon DRUG

180 mcg/week

Peginterferon

Sebivo DRUG

Telbivudine 600 mg daily

Sebivo

entecavir+ vitamin d DRUG

entecavir 1 mg daily+ vitamin d

entecavir + vitamin d

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ziv Hospital: lead

Study Sites (2)

Liver clinic

Safed, 13100, Israel

RECRUITING

Ziv medical center liver unit

Safed, Israel, 13100, Israel

NOT YET RECRUITING

MeSH Terms

Conditions

Hepatitis B

Interventions

Vitamin D; Telbivudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Assy Nimer, MD

CONTACT

+97246828445; ASSY.N@ZIV.HEALTH.GOV.IL

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: March 3, 2010
• First Posted: March 9, 2010
• Study Start: March 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 19, 2011

Record last verified: 2010-03

Locations

IL (2)