Efficacy and Safety of the Combination Vitamin D With Standard of Care in Egyptian Patients With Untreated Chronic Hepatitis C

NCT02099604 | Withdrawn Phase 3 DMC

• 1 other identifier: ANRS 12226 ViZIR
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to show the superiority of a 4 weeks lead-in phase of Vitamin D followed by a 48 weeks combination of Vitamin D with PEG-IFN plus RBV in comparison with standard PEG-IFN + RBV in untreated Egyptian patients with chronic hepatitis C, on the sustained virological response (SVR) at 3 months after end of treatment (week 60).

Conditions

Chronic Hepatitis C

Keywords

Hepatitis C - Genotype 4; SVR (Sustained Virological Response); Vitamin D; Treatment Naïve

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with Sustained Virological Response (SVR).

  Proportion of patients with Sustained Virological Response (SVR) as defined by HCV RNA below the detection limit based on quantitative PCR 12 weeks after stopping treatment.

  60 Weeks after peg-IFN/RBV initiation

Secondary Outcomes (6)

• Rapid Virological Response (RVR)

  4 Weeks after peg-IFN/RBV initiation

• Early Virological Response (EVR)

  12 Weeks after peg-IFN/RBV initiation

• End of Treatment Response (ETR)

  48 Weeks after peg-IFN/RBV initiation

• Normalization of ALT during treatment and 12 weeks after the end of treatment

  From 2 Weeks after peg-IFN/RBV initiation to End of Follow-up (Week 60)

• Incidence of serious adverse events (SAE) grade 3 and 4 (ANRS scale)

  From Lead-in phase (Week -4) to End of Follow-up (Week 60)

Study Arms (2)

Vitamin D

EXPERIMENTAL

Vitamin D + Pegylated Interferon Alpha 2b + Ribavirin

Drug: Vitamin D + Pegylated Interferon Alpha 2b + Ribavirin

Standard of Care

NO INTERVENTION

Pegylated Interferon Alpha 2b + Ribavirin

Interventions

Vitamin D + Pegylated Interferon Alpha 2b + Ribavirin DRUG

Vitamin D ARM: 28000UI/week during 4 weeks (lead in phase) then 28000 UI/week associated with PegIFN/RBV during 48 weeks

Also known as: Vidrop, PegIntron, Rebetol

Vitamin D

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Common with National Program for Viral Hepatitis
• Age: 18 years to 60 years
• Positive HCV antibodies using a third generation test
• Detectable HCV RNA by PCR
• Liver biopsy showing chronic hepatitis with either a METAVIR score F1 with elevated liver enzymes or scores F2/F3
• Naïve to treatment with PEG-IFN and RBV
• HBs antigen negative
• Prothrombin time ≥60 %, normal bilirubin, alpha-foeto protein \< 3\*normal range of the laboratory, anti-nuclear antibodies\<1/160 Effective contraception during the treatment period; no breast-feeding
• Specific to the trial
• Prior approval from the Ministry of Health to be treated as part of the National Program with allocation to Peg-IFN α2b treatment
• Living \<100 km from Cairo and able to come to the centre every week for the treatment
• Signed informed consent and willingness to participate in the trial
• Biopsy slide validated by NHTMRI pathologist

You may not qualify if:

• Common with National program for Viral Hepatitis
• Serious co-morbid conditions such as severe hypertension, heart failure, significant coronary heart disease, poorly controlled diabetes (HbA1C\>8%) , chronic obstructive pulmonary disease
• Major uncontrolled depressive illness
• Solid transplant organ (renal, heart, or lung)
• Untreated thyroid disease
• History of previous anti-HCV therapy
• Body mass index (BMI) greater than 30 kg/m²
• Known human immunodeficiency virus (HIV) coinfection: although HIV testing will not be proposed or done, patients with known HIV coinfection will not be included in the trial
• Anti-HCV therapy contraindications:
• hypersensitivity to one of the two drugs (PEG-IFN, RBV)
• pregnancy or unwilling to comply with adequate contraception
• breast-feeding
• neutropenia (\<1500/mm3)
• anaemia (\<11g/dL for women ; \<12g/dL for men)
• thrombocytopenia (\<100,000/mm3)

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• Institut Pasteur: collaborator

Study Sites (1)

NHTMRI

Cairo, Egypt

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Vitamin D; Ribavirin; peginterferon alfa-2b

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; Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Gamal Esmat, MD, PhD

  NHTMRI, Cairo, Egypt

  STUDY CHAIR

• Arnaud Fontanet, MD, PhD

  Institut Pasteur, Paris France

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: March 31, 2014
• Study Start: April 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: July 12, 2017

Record last verified: 2017-07

Locations

EG (1)