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

Phase 4

Completed

• Conditions: Hepatitis C, Chronic; DIABETES MELLITUS Type 2
• Interventions: Drug: nitazoxanide; Drug: conventional interferon alfa; Drug: Ribavirin

• Registration Number: NCT01770483
• Lead Sponsor: Services Institute of Medical Sciences, Pakistan

Brief Summary

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

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 Timeline

• Study Start: 2011-07
• Study First Submitted: 2013-01-08
• Study First Submitted QC: 2013-01-15
• Study First Posted: 2013-01-17
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Results First Submitted: 2013-03-07
• Results First Submitted QC: 2013-03-07
• Results First Posted: 2013-04-17
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-15
• Last Update Posted: 2013-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group	nitazoxanide	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
study group	conventional interferon alfa	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
control group	conventional interferon alfa	Injection conventional interferon alfa 3 Million International Units alternate days and capsule ribavirin 400mg-1200mg weekly for six months
control group	Ribavirin	Injection conventional interferon alfa 3 Million International Units alternate days and capsule ribavirin 400mg-1200mg weekly for six months
study group	Ribavirin	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Normalization of Alanine Transferase Test	48week	Liver function test,showing resolution of the inflammation of liver parenchyma

Trial Locations

Locations (1)

Endocrinology and Diabetes management centre; 🇵🇰 Lahore, Punjab, Pakistan