Vitamin D as an add-on Therapy With Pegylated Interferon and Ribavirin for Chronic Hepatitis c

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hany Shehab, Cairo University
ClinicalTrials.gov Identifier:
NCT01655966
First received: July 31, 2012
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

Chronic hepatitis C is endemic in Egypt with a high prevalence of the resistant genotype 4. Conventional standard of care treatment has modest response with only 50% sustained virologic response. Recent reports have suggested an augmented response with the addition of vitamin D. This is a prospective randomized trial to assess the effectiveness of adding vitamin D to standard of care for chronic hepatitis C genotype 4.


Condition Intervention Phase
Chronic Hepatitis c
Drug: vitamin D +pegylated interferon + ribavirin
Drug: pegylated interferon + ribavirin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vitamin D in Addition to Pegylated Interferon and Ribavirin Compared to Pegylated Interferon and Ribavirin Alone in the Treatment of Chronic Hepatitis C Genotype 4.

Resource links provided by NLM:


Further study details as provided by Cairo University:

Primary Outcome Measures:
  • Sustained virologic response [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
    Undetectable HCV-RNA 24 weeks after end of treatment.


Secondary Outcome Measures:
  • rapid virologic response [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    undetectable HCV-RNA 4 weeks after commencement of treatment

  • End-of-treatment response [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    undetectable HCV-RNA 48 weeks after commencement of treatment

  • Adverse events [ Time Frame: 72 weeks ] [ Designated as safety issue: Yes ]
    Adverse events that could be reasonably and temporally associated with administration of drugs

  • early virologic response [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    Early virologic response: undetectable HCV-RNA 12 weeks after commencement of treatment.

    Partial early virologic response: decrease of more than 2login HCV-RNA.

    No early virologic response: increase, stationary or decreased less than 2log HCV-RNA.



Estimated Enrollment: 80
Study Start Date: May 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard of care
Group A: comprises 40 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
Drug: pegylated interferon + ribavirin
pegylated interferon 160ug once weekly Ribavirin (> 75kg:1200 mg, <75kg:1000mg daily)48 weeks
Experimental: Triple therapy
Group B: comprises 40 treatment-naive chronic HCV patients who will receive oral vitamin D 1mcg once daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
Drug: vitamin D +pegylated interferon + ribavirin
Vitamin D: 1mcg once daily 48 weeks Pegylated interferon 160ug once weekly 48 weeks Ribavirin(> 75kg:1200 mg, <75kg:1000mg daily)48 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult (male or female), 18 to 65 years of age, with chronic HCV infection
  • Liver biopsy showing chronic hepatitis with significant fibrosis using Ishak scoring system
  • Compensated liver disease; serum bilirubin < 1.5 mg/dl, INR no more than 1.5, serum albumin > 3.4, platelet count > 75,000 mm, and no evidence of hepatic decompensation (hepatic encephalopathy or ascites)
  • Acceptable hematological and biochemical indices (hemoglobin 12.5g/dl for men and 12 g/dl for women; neutrophil count 1500/mm3 or more and serum creatinine < 1.5 mg/dl
  • Patients must be serum hepatitis B surface antigen (HBsAg) negative
  • Negative Antinuclear Antibodies (ANA) or titer of < 1:160
  • Serum positive for anti-HCV antibodies and HCV-RNA
  • Abdominal Ultrasound obtained within 3 months prior to entry in the study
  • Electrocardiogram for men aged > 40 years and for women aged > 50 years
  • Normal fundus examination
  • Proper contraception measure throughout the course of treatment and six months later
  • Female patients must not breast feed during therapy

Exclusion Criteria:

  • Patients who previously received interferon
  • HgbA1c > 7.5 or history of diabetes mellitus
  • BMI > 34
  • Women who are pregnant or breast-feeding
  • Males whose female partners are either pregnant or of child-bearing potential or not using birth control and are sexually active
  • Other causes of liver disease including autoimmune hepatitis
  • Transplant recipients receiving immune suppression therapy
  • Screening tests positive for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab or anti-HIV Ab
  • Decompensated cirrhosis, history of variceal bleeding, ascites, hepatic encephalopathy, CTP score > 6 or MELD score > 8
  • Absolute neutrophil count < 1500 cells/mm3; platelet count < 135,000 cells/mm3; hemoglobin < 12 g/dL for women and < 12.5 g/dL for men; or serum creatinine concentration ≥ 1.5 times ULN
  • Hypothyroidism or hyperthyroidism not effectively treated with medication
  • Alcohol consumption of > 40 grams per day or an alcohol use pattern that will interfere with the study
  • History or other clinical evidence of significant or unstable cardiac disease
  • History or other clinical evidence of chronic pulmonary disease associated with functional impairment
  • Serious or severe bacterial infection(s)
  • History of severe or uncontrolled psychiatric disease, including severe depression, history of suicidal ideation, suicidal attempts or psychosis requiring medication and/or hospitalization
  • History of uncontrolled severe seizure disorder
  • History of immunologically mediated disease requiring more than intermittent anti-inflammatory medications for management or that requires frequent or prolonged use of corticosteroids
  • Patients with clinically significant retinal abnormalities

    • Subjects receiving vitamin D for any other medical condition.
    • Subjects with significant active rheumatologic or orthopaedic conditions.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01655966

Locations
Egypt
National Railway Hospital Center
Cairo, Egypt
Sponsors and Collaborators
Cairo University
Investigators
Principal Investigator: Tamer Elbaz, MD Cairo University
Study Director: Hany Shehab, MD Cairo University
  More Information

No publications provided

Responsible Party: Hany Shehab, Dr, Cairo University
ClinicalTrials.gov Identifier: NCT01655966     History of Changes
Other Study ID Numbers: RAIL002
Study First Received: July 31, 2012
Last Updated: January 28, 2014
Health Authority: Egypt: Institutional Review Board

Keywords provided by Cairo University:
chronic hepatitis c
hcv
vitamin d

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 April 16, 2014