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Completed

NCT Number: NCT01770483

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

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.

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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases Diabetes Mellitus Diabetes Mellitus Type 2 Diabetes Mellitus, Type 2 Digestive System Diseases Disease Attributes Endocrine System Diseases Flaviviridae Infections Glucose Metabolism Disorders Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

35 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Endocrinology and Diabetes management centre

Lahore, Punjab Province, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nitazoxanide

Drug

nitazoxanide 500mg twice daily

Other names: tablet nizonide500mg, tablet atizox500mg

conventional interferon alfa

Drug

Inj interferon 3 Million International Units thrice weekly

Other names: Inj uniferon 3 Million International Units

Ribavirin

Drug

ribazole

Other names: Ribavirin 400mg-1200mg

Primary outcomes

  1. 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 outcomes

  1. Normalization of Alanine Transferase Test

    Time frame: 48week

    Liver function test,showing resolution of the inflammation of liver parenchyma

Sponsors and collaborators

Lead sponsor

Services Institute of Medical Sciences, Pakistan

Other Gov

Collaborators

  • Getz Pharma

Registry information

Acronym: HEP-C-FM

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 17, 2013
Registry last updated
Sep 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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