Back to resultsEfficacy of Vitamin D on Top of Pegylated Interferon and Ribavirin in Patients With Chronic Viral Hepatitis C Null-Responders (ANRS VITAVIC)
Primary Purpose
Chronic Hepatitis C
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
vitamin D
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis C
Eligibility Criteria
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
Sites / Locations
- Hôpital Pitié Salpêtrière
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Addition of Vitamin D to Peg-interferon plus Ribavirin
Arm Description
Outcomes
Primary Outcome Measures
Negativity of HCV RNA below 12UI/mL after 12 weeks of antiviral combination therapy
Secondary Outcome Measures
Changes in HCV viral load after correction of vitamin D deficiency (delta log)
Changes in HCV viral load (delta log)
Changes in HCV viral load (delta log)
Negativity of HCV RNA below 12 UI/ml
Negativity of HCV RNA below 12 UI/ml
Full Information
NCT ID
NCT01226446
First Posted
October 20, 2010
Last Updated
August 8, 2014
Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
1. Study Identification
Unique Protocol Identification Number
NCT01226446
Brief Title
Efficacy of Vitamin D on Top of Pegylated Interferon and Ribavirin in Patients With Chronic Viral Hepatitis C Null-Responders
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Addition of Vitamin D to Peg-interferon plus Ribavirin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
vitamin D
Intervention Description
Vitamin D on top of the standard treatment
Primary Outcome Measure Information:
Title
Negativity of HCV RNA below 12UI/mL after 12 weeks of antiviral combination therapy
Time Frame
at week 12
Secondary Outcome Measure Information:
Title
Changes in HCV viral load after correction of vitamin D deficiency (delta log)
Time Frame
at day 0
Title
Changes in HCV viral load (delta log)
Time Frame
at week 4
Title
Changes in HCV viral load (delta log)
Time Frame
at week 12
Title
Negativity of HCV RNA below 12 UI/ml
Time Frame
at week 24
Title
Negativity of HCV RNA below 12 UI/ml
Time Frame
at week 72
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrice Cacoub, MD
Organizational Affiliation
Pitié Salpétrière Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Pitié Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
25987791
Citation
Terrier B, Lapidus N, Pol S, Serfaty L, Ratziu V, Asselah T, Thibault V, Souberbielle JC, Carrat F, Cacoub P. Vitamin D in addition to peg-interferon-alpha/ribavirin in chronic hepatitis C virus infection: ANRS-HC25-VITAVIC study. World J Gastroenterol. 2015 May 14;21(18):5647-53. doi: 10.3748/wjg.v21.i18.5647.
Results Reference
derived
Learn more about this trial
Efficacy of Vitamin D on Top of Pegylated Interferon and Ribavirin in Patients With Chronic Viral Hepatitis C Null-Responders
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