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

Primary Purpose

Chronic Hepatitis c

Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
vitamin D +pegylated interferon + ribavirin
pegylated interferon + ribavirin
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis c focused on measuring chronic hepatitis c, hcv, vitamin d

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Railway Hospital Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of care

Triple therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Sustained virologic response
Undetectable HCV-RNA 24 weeks after end of treatment.

Secondary Outcome Measures

rapid virologic response
undetectable HCV-RNA 4 weeks after commencement of treatment
End-of-treatment response
undetectable HCV-RNA 48 weeks after commencement of treatment
Adverse events
Adverse events that could be reasonably and temporally associated with administration of drugs
early virologic response
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.

Full Information

First Posted
July 31, 2012
Last Updated
January 28, 2014
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT01655966
Brief Title
Vitamin D as an add-on Therapy With Pegylated Interferon and Ribavirin for Chronic Hepatitis c
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
April 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis c
Keywords
chronic hepatitis c, hcv, vitamin d

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Triple therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
vitamin D +pegylated interferon + ribavirin
Intervention Description
Vitamin D: 1mcg once daily 48 weeks Pegylated interferon 160ug once weekly 48 weeks Ribavirin(> 75kg:1200 mg, <75kg:1000mg daily)48 weeks
Intervention Type
Drug
Intervention Name(s)
pegylated interferon + ribavirin
Intervention Description
pegylated interferon 160ug once weekly Ribavirin (> 75kg:1200 mg, <75kg:1000mg daily)48 weeks
Primary Outcome Measure Information:
Title
Sustained virologic response
Description
Undetectable HCV-RNA 24 weeks after end of treatment.
Time Frame
72 weeks
Secondary Outcome Measure Information:
Title
rapid virologic response
Description
undetectable HCV-RNA 4 weeks after commencement of treatment
Time Frame
4 weeks
Title
End-of-treatment response
Description
undetectable HCV-RNA 48 weeks after commencement of treatment
Time Frame
48 weeks
Title
Adverse events
Description
Adverse events that could be reasonably and temporally associated with administration of drugs
Time Frame
72 weeks
Title
early virologic response
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamer Elbaz, MD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hany Shehab, MD
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
National Railway Hospital Center
City
Cairo
Country
Egypt

12. IPD Sharing Statement

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

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