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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) ( French National Agency for Research on AIDS and Viral Hepatitis )
ClinicalTrials.gov Identifier:
NCT01226446
First received: October 20, 2010
Last updated: June 7, 2012
Last verified: June 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Chronic Hepatitis C
 Drug: vitamin D
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures:
  • Negativity of HCV RNA below 12UI/mL after 12 weeks of antiviral combination therapy [ Time Frame: at week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in HCV viral load after correction of vitamin D deficiency (delta log) [ Time Frame: at day 0 ] [ Designated as safety issue: No ]
  • Changes in HCV viral load (delta log) [ Time Frame: at week 4 ] [ Designated as safety issue: No ]
  • Changes in HCV viral load (delta log) [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
  • Negativity of HCV RNA below 12 UI/ml [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • Negativity of HCV RNA below 12 UI/ml [ Time Frame: at week 72 ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: November 2010
Estimated Study Completion Date: January 2013
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Addition of Vitamin D to Peg-interferon plus Ribavirin Drug: vitamin D
Vitamin D on top of the standard treatment

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01226446

Locations
France
Hôpital Pitié Salpêtrière
Paris, France, 75013
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Investigators
Principal Investigator: Patrice Cacoub, MD Pitié Salpétrière Hospital
  More Information

No publications provided

Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) ( French National Agency for Research on AIDS and Viral Hepatitis )
ClinicalTrials.gov Identifier: NCT01226446     History of Changes
Other Study ID Numbers: 2010-021967-34
Study First Received: October 20, 2010
Last Updated: June 7, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Vitamin D
Ergocalciferols
 Vitamins
Interferons
Ribavirin
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013