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

Chronic Hepatitis c Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01655966
• Other study ID #: RAIL002
• Status: Active, not recruiting
• Phase: Phase 3
• First received: July 31, 2012
• Last updated: January 28, 2014
• Start date: May 2012
• Est. completion date: April 2014

Study information

• Verified date: January 2014
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: April 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis c
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

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
• pegylated interferon + ribavirin
pegylated interferon 160ug once weekly Ribavirin (> 75kg:1200 mg, <75kg:1000mg daily)48 weeks

Locations

Country	Name	City	State
Egypt	National Railway Hospital Center	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained virologic response	Undetectable HCV-RNA 24 weeks after end of treatment.	72 weeks	No
Secondary	rapid virologic response	undetectable HCV-RNA 4 weeks after commencement of treatment	4 weeks	No
Secondary	End-of-treatment response	undetectable HCV-RNA 48 weeks after commencement of treatment	48 weeks	No
Secondary	Adverse events	Adverse events that could be reasonably and temporally associated with administration of drugs	72 weeks	Yes
Secondary	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.	12 weeks	No