Efficacy of Vitamin D on Top of Pegylated Interferon and Ribavirin in Patients With Chronic Viral Hepatitis C Null-Responders

Chronic Hepatitis C Clinical Trial

— ANRS VITAVIC  

Official title:

Multicenter Open and Prospective Trial Assessing the Efficacy of Vitamin D Supplementation in Addition to Pegylated Interferon Plus Ribavirin in Null-Responders Patients With Chronic Viral Hepatitis C Genotype 1 or 4

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01226446
• Other study ID #: 2010-021967-34
• Status: Completed
• Phase: Phase 2
• First received: October 20, 2010
• Last updated: August 8, 2014
• Start date: November 2010
• Est. completion date: January 2013

Study information

• Verified date: June 2012
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

Vitamin D deficiency is commonly found in patients with chronic hepatitis C. The investigators hypothesize that the correction of hypovitaminosis D before the initiation of anti-HCV combination therapy and the maintenance of an optimal vitamin D status during antiviral therapy could improve the antiviral efficacy

Description:

An open-label, prospective evaluation of the efficacy of vitamin D supplementation starting 1 month before and continuing for the duration of combination therapy with pegylated interferon alpha (2a or 2b) plus ribavirin in patients with chronic viral hepatitis C genotype 1 or 4, nonresponders to a first antiviral therapy.Vitamin D supplementation is started one month before antiviral therapy in order to introduce pegylated interferon plus ribavirin in patients with optimal vitamin D status

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 2013
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Chronic Hepatitis C Genotype 1 or 4

• Hypovitaminosis D defined by a value <30 ng / ml

• Patient non responder to previous antiviral combination therapy of Pegylated Interferon and Ribavirin defined by a decrease in viral load <2 log at week 12 of the first course (Peg/RBV)

• Patient who received at least 80% of the optimal dose of Pegylated Interferon and Ribavirin according to current recommendations

• Patient for which the investigating physician decided to initiate treatment for hepatitis C combination therapy

Exclusion Criteria:

• Decompensated liver disease: Child-Pugh B> 8 or one of the following criteria:

bilirubin> 35 micromol/L, TP <50%, ascites, recurrent encephalopathy

• Positive serology for HBV and HIV

• Alcohol consumption exceeding 50 g/day

• Chronic intake of vitamin D

• Thrombocytopenia <50 000/mm ³, neutropenia <750/mm ³, hemoglobin <11 g/dL

• Pregnant women

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• vitamin D
Vitamin D on top of the standard treatment

Locations

Country	Name	City	State
France	Hôpital Pitié Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
French National Agency for Research on AIDS and Viral Hepatitis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Negativity of HCV RNA below 12UI/mL after 12 weeks of antiviral combination therapy		at week 12	No
Secondary	Changes in HCV viral load after correction of vitamin D deficiency (delta log)		at day 0	No
Secondary	Changes in HCV viral load (delta log)		at week 4	No
Secondary	Changes in HCV viral load (delta log)		at week 12	No
Secondary	Negativity of HCV RNA below 12 UI/ml		at week 24	No
Secondary	Negativity of HCV RNA below 12 UI/ml		at week 72	No