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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 C
Hepatitis, Chronic
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
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014