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

NCT ID: NCT01770483

Last Updated: 2013-09-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-03-31

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.

Conditions

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Hepatitis C, Chronic DIABETES MELLITUS Type 2

Keywords

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Nitazoxanide, Sustained viral response Type 2 DIABETICS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

nitazoxanide

Intervention Type DRUG

nitazoxanide 500mg twice daily

conventional interferon alfa

Intervention Type DRUG

Inj interferon 3 Million International Units thrice weekly

Ribavirin

Intervention Type DRUG

ribazole

control group

Injection conventional interferon alfa 3 Million International Units alternate days and capsule ribavirin 400mg-1200mg weekly for six months

Group Type ACTIVE_COMPARATOR

conventional interferon alfa

Intervention Type DRUG

Inj interferon 3 Million International Units thrice weekly

Ribavirin

Intervention Type DRUG

ribazole

Interventions

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nitazoxanide

nitazoxanide 500mg twice daily

Intervention Type DRUG

conventional interferon alfa

Inj interferon 3 Million International Units thrice weekly

Intervention Type DRUG

Ribavirin

ribazole

Intervention Type DRUG

Other Intervention Names

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tablet nizonide500mg tablet atizox500mg Inj uniferon 3 Million International Units Ribavirin 400mg-1200mg

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
Minimum Eligible Age

35 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Getz Pharma

INDUSTRY

Sponsor Role collaborator

Services Institute of Medical Sciences, Pakistan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Prof. Faisal Masud

Principal SIMS

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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FAISAL MASUD, FRCP

Role: STUDY_DIRECTOR

Principal SIMS/Services hospital lahore

AMENA MIRZA, MRCP,FCPS

Role: PRINCIPAL_INVESTIGATOR

Senior registrar ,Services hospital lahore/SIMS

Madiha Fida, MBBS

Role: PRINCIPAL_INVESTIGATOR

House Officer Services Hospital Lahore

Locations

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Endocrinology and Diabetes management centre

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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SIMS

Identifier Type: -

Identifier Source: org_study_id