Status:
COMPLETED
Efficacy of Vitamin D on Top of Pegylated Interferon and Ribavirin in Patients With Chronic Viral Hepatitis C Null-Responders
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 therap...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01226446
Start Date
November 1 2010
End Date
January 1 2013
Last Update
August 11 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hôpital Pitié Salpêtrière
Paris, France, 75013