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

NCT01226446 | Completed Phase 2

• 1 other identifier: 2010-021967-34
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Negativity of HCV RNA below 12UI/mL after 12 weeks of antiviral combination therapy

  at week 12

Secondary Outcomes (5)

• 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 4

• Changes in HCV viral load (delta log)

  at week 12

• Negativity of HCV RNA below 12 UI/ml

  at week 24

• Negativity of HCV RNA below 12 UI/ml

  at week 72

Study Arms (1)

Addition of Vitamin D to Peg-interferon plus Ribavirin

EXPERIMENTAL

Drug: vitamin D

Interventions

vitamin D DRUG

Vitamin D on top of the standard treatment

Addition of Vitamin D to Peg-interferon plus Ribavirin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• French National Agency for Research on AIDS and Viral Hepatitis: lead

Study Sites (1)

Hôpital Pitié Salpêtrière

Paris, 75013, France

Location

Related Publications (1)

• 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.

  PMID: 25987791 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Patrice Cacoub, MD

  Pitié Salpétrière Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2010
• First Posted: October 22, 2010
• Study Start: November 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: January 1, 2013
• Last Updated: August 11, 2014

Record last verified: 2012-06

Locations

FR (1)