Clinical trial NCT01655966: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chronic Hepatitis c
Keywords: chronic hepatitis c
hcv
vitamin d
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2012-08-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Sustained virologic response
timeFrame: 72 weeks
Secondary outcomes:
measure: rapid virologic response
timeFrame: 4 weeks
measure: End-of-treatment response
timeFrame: 48 weeks
measure: Adverse events
timeFrame: 72 weeks
measure: early virologic response
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Railway Hospital Center
Study officials:
affiliation: Cairo University
name: Tamer Elbaz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Hany Shehab, MD
role: STUDY_DIRECTOR
References: