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

NCT01655966 | Unknown Phase 3 DMC

• 1 other identifier: RAIL002
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis c

Keywords

chronic hepatitis c; hcv; vitamin d

Outcome Measures

Primary Outcomes (1)

• Sustained virologic response

  Undetectable HCV-RNA 24 weeks after end of treatment.

  72 weeks

Secondary Outcomes (4)

• rapid virologic response

  4 weeks

• End-of-treatment response

  48 weeks

• Adverse events

  72 weeks

• early virologic response

  12 weeks

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

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

Triple therapy

EXPERIMENTAL

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

Interventions

vitamin D +pegylated interferon + ribavirin DRUG

Vitamin D: 1mcg once daily 48 weeks Pegylated interferon 160ug once weekly 48 weeks Ribavirin(\> 75kg:1200 mg, \<75kg:1000mg daily)48 weeks

Triple therapy

pegylated interferon + ribavirin DRUG

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

Standard of care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

National Railway Hospital Center

Cairo, Egypt

Location

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Tamer Elbaz, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

• Hany Shehab, MD

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: July 31, 2012
• First Posted: August 2, 2012
• Study Start: May 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: April 1, 2014
• Last Updated: January 29, 2014

Record last verified: 2014-01

Locations

EG (1)