Vitamin D and Vitamin B12 Supplementation With Pegylated Interferon-Alfa Plus Ribavirin for Treating Chronic Hepatitis C

NCT02120274 | Terminated Phase 4

• 2 other identifiers: DB12SHCVU1111-1155-6986
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effectiveness of the supplementation of vitamins D and B12 in combination with Pegylated Interferon-Alfa and Ribavirin in the treatment of genotype 1 chronic hepatitis C, who do not qualify to receive protease inhibitor in Brazil.

Conditions

RNA Virus Infections; Flaviviridae Infections; Hepatitis C; Hepatitis C, Chronic

Keywords

RNA Virus Infections; Flaviviridae Infections; Hepatitis C; Hepatitis C, Chronic; Vitamin D; Cholecalciferol; Vitamin B 12

Outcome Measures

Primary Outcomes (1)

• SVR12

  Proportion of patients with SVR, defined as HCV RNA bellow the limit of detection 12 weeks after treatment completion with peguilated alfainterferon-2B plus ribavirin, with or without vitamin supplementation.

  12 weeks after treatment completion

Secondary Outcomes (1)

• RVR, EVR, EOT

  week 4, week 12 and at the end-of-treatment.

Study Arms (2)

Control

NO INTERVENTION

Pegylated Interferon-Alfa plus ribavirin for 48 weeks

Vitamins

EXPERIMENTAL

Pegylated Interferon-Alfa plus ribavirin for 48 weeks together oral vitamin D 2,000 IU qd throughout, irrespective of baseline vitamin D level. Intramuscular vitamin B12 5000 UI will be given weekly in the first 12 weeks followed by a monthly injection until the end of therapy.

Drug: Vitamin D; Drug: Vitamin B 12

Interventions

Vitamin D DRUG

Oral vitamin D 2,000 IU qd throughout, irrespective of baseline vitamin D level.

Vitamins

Vitamin B 12 DRUG

Intramuscular vitamin B12 5000 UI will be given weekly in the first 12 weeks followed by a monthly injection until the end of therapy.

Vitamins

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Genotype 1 HCV infection confirmed a positive test for anti-HCV antibody and detectable serum HCV RNA by PCR
• Pegylated Interferon-Alfa treatment naïve
• Liver biopsy with Metavir F2 or less
• Cognitive capacity to understand and sign the informed consent

You may not qualify if:

• HBV or HIV co-infection
• Hemoglobin level less than 10 g/dL or total neutrophil count less than 1,500/mm3 or platlet count below 75,000/mm3
• Creatinin ≥ 1.5 mg/dL
• Severe cardiopathy
• Pregnancy or impossibility to use birth control methods by the couple, or breast-feeding
• Conditions that, according to the investigator's judgement, preclude participation in the study, including clinical, cognitive or behavioural conditions

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Outpatient Clinic of Viral Hepatitis (NUPAIG)

São Paulo, São Paulo, 04025-001, Brazil

Location

MeSH Terms

Conditions

RNA Virus Infections; Flaviviridae Infections; Hepatitis C; Hepatitis C, Chronic

Interventions

Vitamin D; Vitamin B 12

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds

Study Officials

• Adauto Castelo, PhD

  Federal University of São Paulo

  STUDY DIRECTOR

• Jorge F Senise, PhD

  Federal University of São Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Henrique Pott-Junior

Study Record Dates

• First Submitted: April 18, 2014
• First Posted: April 22, 2014
• Study Start: March 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: August 24, 2016

Record last verified: 2016-08

Locations

BR (1)