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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hepatitis C, Chronic, DIABETES MELLITUS Type 2

Intervention / Treatment
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* Drug: nitazoxanide
* Drug: conventional interferon alfa
* Drug: Ribavirin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>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<br>* nitazoxanide 500mg twice daily<br>* Other names: tablet atizox500mg;Drug: conventional interferon alfa<br>* Inj interferon 3 Million International Units thrice weekly<br>* Other names: Inj uniferon 3 Million International Units;Drug: Ribavirin<br>* ribazole<br>* Other names: Ribavirin 400mg-1200mg;|
| Active Comparator: control group<br>Injection conventional interferon alfa 3 Million International Units alternate days and capsule ribavirin 400mg-1200mg weekly for six months | Drug: conventional interferon alfa<br>* Inj interferon 3 Million International Units thrice weekly<br>* Other names: Inj uniferon 3 Million International Units;Drug: Ribavirin<br>* ribazole<br>* Other names: Ribavirin 400mg-1200mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Viral Response, | 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 | Liver function test,showing resolution of the inflammation of liver parenchyma | 48week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nitazoxanide,, Sustained viral response, Type 2 DIABETICS