The Role Of Nitazoxanide, Interferon Alfa And Ribavirin In Treatment Of Hepatitis C Infected Type 2 Diabetic Patients (HEP-C-FM)

September 15, 2013 updated by: Prof. Faisal Masud, Services Institute of Medical Sciences, Pakistan
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan
        • Endocrinology and Diabetes management centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

31 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: nitazoxanide
nitazoxanide 500mg twice daily
Other Names:
  • tablet nizonide500mg
  • tablet atizox500mg
Drug: conventional interferon alfa
Inj interferon 3 Million International Units thrice weekly
Other Names:
  • Inj uniferon 3 Million International Units
Drug: Ribavirin
ribazole
Other Names:
  • Ribavirin 400mg-1200mg
Active Comparator: control group
Injection conventional interferon alfa 3 Million International Units alternate days and capsule ribavirin 400mg-1200mg weekly for six months
Drug: conventional interferon alfa
Inj interferon 3 Million International Units thrice weekly
Other Names:
  • Inj uniferon 3 Million International Units
Drug: Ribavirin
ribazole
Other Names:
  • Ribavirin 400mg-1200mg

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Services Institute of Medical Sciences, Pakistan

Collaborators

Getz Pharma

Investigators

  • Study Director: FAISAL MASUD, FRCP, Principal SIMS/Services hospital lahore
  • Principal Investigator: AMENA MIRZA, MRCP,FCPS, Senior registrar ,Services hospital lahore/SIMS
  • Principal Investigator: Madiha Fida, MBBS, House Officer Services Hospital Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

January 8, 2013

First Submitted That Met QC Criteria

January 15, 2013

First Posted (Estimate)

January 17, 2013

Study Record Updates

Last Update Posted (Estimate)

September 20, 2013

Last Update Submitted That Met QC Criteria

September 15, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIMS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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