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

A

ANRS, Emerging Infectious Diseases

Status and phase

Withdrawn
Phase 3

Conditions

Chronic Hepatitis C

Treatments

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

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02099604
ANRS 12226 ViZIR

Details and patient eligibility

About

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).

Full description

  • Method: Phase III, randomized, open-label superiority clinical trial, among Egyptian patients with chronic hepatitis C.

  • Treatment strategy: Vitamin D Arm: Vitamin D over a 4 weeks lead-in phase followed by Vitamin D in combination with PEG-INF plus RBV during 48 weeks. Standard of Care Arm: PEG-INF plus RBV during 48 weeks.

  • Main outcome: 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.

  • Sample Size: 520 patients (260 per arm)
  • Enrollment period: 12 months
  • Patient's participation duration: 62 weeks (SOC Arm), 66 weeks (Vit-D Arm)
  • Statistical analysis:

The superiority of the vitamin D arm will be tested against the standard PEG IFN + RBV combination. 260 patients in each arm will give 80% power to document a 12% difference in the SVR rates between the experimental (Vitamin D) and the control (standard treatment) arms..

A futility analysis is planned for this study, in order to be able to interrupt the trial prematurely in case preliminary results show a lack of efficacy of vitamin D.

This analysis will be performed on half of the patients, thus 260 patients (130 patients per arm), on a week 12/14 week criterion (HCV RNA viral load at W12/W14).

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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
  • Naïve to treatment with vitamin D (received vitamin D less than 30 consecutive days in the 3 months preceding inclusion)
  • Biopsy slide validated by NHTMRI pathologist

Exclusion criteria

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)
  • elevated creatinin (>1.5mg/dL)
  • concomitant liver disease other than hepatitis C (immuno-active chronic hepatitis B, autoimmune hepatitis, alcoholic liver disease, hemochromatosis, alpha-1 antitrypsin deficiency, Wilson disease)
  • liver biopsy showing severe steatosis (>66%) and steatohepatitis; decompensated cirrhosis (Child Pugh>A); hepatocellular carcinoma, METAVIR score F4.
  • TSH>5 mU/L

Specific to the trial

  • Patients allocated to Peg-IFN alpha 2a treatment
  • Hypersensitivity to vitamin D
  • Vitamin D contraindications:
  • hypercalcaemia (fasting calcaemia >105 mg/L or 2.62 mmol/L)
  • ratio calciuria / creatininuria (fasting ratio >1 mmol Ca/mmol creatinin)
  • hyperphosphatemia (>1.5 mmol/L)
  • calcium lithiasis
  • patients being treated with thiazide diuretics (risk of hypercalcaemia with vitamin D treatment)
  • patients being treated with glucocorticoïds (decrease in vitamin D efficacy)
  • postmenopausal women treated by vitamin D and calcium for osteoporosis
  • Treatment by vitamin D more than 30 consecutive days in the 3 months preceding inclusion in the trial.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Vitamin D
Experimental group
Description:
Vitamin D + Pegylated Interferon Alpha 2b + Ribavirin
Treatment:
Drug: Vitamin D + Pegylated Interferon Alpha 2b + Ribavirin
Standard of Care
No Intervention group
Description:
Pegylated Interferon Alpha 2b + Ribavirin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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