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

Phase 2

Completed

• Conditions: Chronic Hepatitis C
• Interventions: Drug: vitamin D

• Registration Number: NCT01226446
• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis

Brief 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

Detailed 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

Study Timeline

• Study First Submitted: 2010-10-20
• Study First Submitted QC: 2010-10-21
• Study First Posted: 2010-10-22
• Study Start: 2010-11
• Primary Completion: 2012-02
• Status Verified: 2012-06
• Study Completion: 2013-01
• Last Update Submitted: 2014-08-08
• Last Update Posted: 2014-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Addition of Vitamin D to Peg-interferon plus Ribavirin	vitamin D	-

Primary Outcome Measures

Name	Time	Method
Negativity of HCV RNA below 12UI/mL after 12 weeks of antiviral combination therapy	at week 12

Secondary Outcome Measures

Name	Time	Method
Changes in HCV viral load after correction of vitamin D deficiency (delta log)	at day 0
Changes in HCV viral load (delta log)	at week 12
Negativity of HCV RNA below 12 UI/ml	at week 72

Trial Locations

Locations (1)

Hôpital Pitié Salpêtrière; 🇫🇷 Paris, France