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

Hepatitis B Virus Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01083251
• Other study ID #: 004-10
• Status: Recruiting
• Phase: N/A
• First received: March 3, 2010
• Last updated: January 17, 2011
• Start date: March 2010
• Est. completion date: December 2012

Study information

• Verified date: March 2010
• Source: Ziv Hospital
• Contact: Assy Nimer, MD
• Phone: +97246828445
• Email: ASSY.N[@]ZIV.HEALTH.GOV.IL
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B
• Hepatitis B Virus

Intervention

Drug:
• Peginterferon + Vitamin D
180 mcg/week + 400 IUX2/day
• Peginterferon
180 mcg/week
• Sebivo
Telbivudine 600 mg daily
• entecavir+ vitamin d
entecavir 1 mg daily+ vitamin d

Locations

Country	Name	City	State
Israel	Liver clinic	Safed
Israel	Ziv medical center liver unit	Safed, Israel

Sponsors (1)

Lead Sponsor	Collaborator
Ziv Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	treatment efficacy	The primary end point will be sustained viral response which was de?ned 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	No
Primary	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	No