The Role Of Nitazoxanide, Interferon Alfa And Ribavirin In Treatment Of Hepatitis C Infected Type 2 Diabetic Patients

Overview

The purpose of this study is to investigate if nitazoxanide used in combination with interferon alfa and ribavirin is effective in treating Hepatitis c infected type 2 Diabetic patients by improving their sustained viral response by more than 80%.Considering that the study is being conducted in a third world country like Pakistan, the standard treatment of hepatitis C is not cost effective. The aim is to introduce a new treatment comparable in efficacy to peginterferon and also cost effective.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2013

Detailed Description

After taking proper informed consent from patients, patients who fulfill the research criteria are randomized into 2 groups (control/study). Patients in both groups will be treated with conventional interferon alfa and Ribavirin.Those in study group will be given tab nitazoxanide 500mg twice daily in addition to conventional treatment. The patients will be followed up at regular intervals: 0,4,12,24,48 week.At each visit Hepatitis C Virus(PCR)RNA, Liver function tests, complete blood count will be done.

Interventions

  • Drug: nitazoxanide
    • nitazoxanide 500mg twice daily
  • Drug: conventional interferon alfa
    • Inj interferon 3 Million International Units thrice weekly
  • Drug: Ribavirin
    • ribazole

Arms, Groups and Cohorts

  • Experimental: study group
    • Tablet Nitazoxanide 500mg twice daily will be added to the injection conventional interferon alfa 3 Million International Units alternate days and capsule Ribavirin 400mg-1200mg weekly for six months
  • Active Comparator: control group
    • Injection conventional interferon alfa 3 Million International Units alternate days and capsule ribavirin 400mg-1200mg weekly for six months

Clinical Trial Outcome Measures

Primary Measures

  • Sustained Viral Response,
    • Time Frame: 48 WEEK
    • Sustained viral response ,is negative Hepatitis C Virus(PCR)RNA test six months after end of treatment.

Secondary Measures

  • Normalization of Alanine Transferase Test
    • Time Frame: 48week
    • Liver function test,showing resolution of the inflammation of liver parenchyma

Participating in This Clinical Trial

Inclusion Criteria

  • Hepatitis C genotype 3a – Hepatitis C Virus(PCR)RNA Detected – Alanine transaminase >60 – Diabetic HbA1c<8 – BMI>23 Exclusion Criteria:

  • Previously treated Hepatitis C patients – Pregnant females – Decompensated liver disease,Child class B OR above – Thyroid disease,Thyroid stimulating hormone>10,0.05 – Absolute neutrophil count<1500,Platelets<80,000,Hb<10g Female,<11g Male – Severe cardiac disease,New York Heart Association2 – Moderate to severe depression assessed by Beck Depression Inventory scale

Gender Eligibility: All

Minimum Age: 35 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Services Institute of Medical Sciences, Pakistan
  • Collaborator
    • Getz Pharma
  • Provider of Information About this Clinical Study
    • Principal Investigator: Prof. Faisal Masud, Principal SIMS – Services Institute of Medical Sciences, Pakistan
  • Overall Official(s)
    • FAISAL MASUD, FRCP, Study Director, Principal SIMS/Services hospital lahore
    • AMENA MIRZA, MRCP,FCPS, Principal Investigator, Senior registrar ,Services hospital lahore/SIMS
    • Madiha Fida, MBBS, Principal Investigator, House Officer Services Hospital Lahore

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