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

Primary Purpose

Hepatitis C, Chronic, DIABETES MELLITUS Type 2

Status
Completed
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
nitazoxanide
conventional interferon alfa
Ribavirin
Sponsored by
Services Institute of Medical Sciences, Pakistan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic focused on measuring Nitazoxanide,, Sustained viral response, Type 2 DIABETICS

Eligibility Criteria

35 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Endocrinology and Diabetes management centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

study group

control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Normalization of Alanine Transferase Test
Liver function test,showing resolution of the inflammation of liver parenchyma

Full Information

First Posted
January 8, 2013
Last Updated
September 15, 2013
Sponsor
Services Institute of Medical Sciences, Pakistan
Collaborators
Getz Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT01770483
Brief Title
The Role Of Nitazoxanide, Interferon Alfa And Ribavirin In Treatment Of Hepatitis C Infected Type 2 Diabetic Patients
Acronym
HEP-C-FM
Official Title
The Role Of Nitazoxanide, Interferon Alfa And Ribavirin In Treatment Of Hepatitis C Infected Type 2 Diabetic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Services Institute of Medical Sciences, Pakistan
Collaborators
Getz Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic, DIABETES MELLITUS Type 2
Keywords
Nitazoxanide,, Sustained viral response, Type 2 DIABETICS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm Description
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
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Injection conventional interferon alfa 3 Million International Units alternate days and capsule ribavirin 400mg-1200mg weekly for six months
Intervention Type
Drug
Intervention Name(s)
nitazoxanide
Other Intervention Name(s)
tablet nizonide500mg, tablet atizox500mg
Intervention Description
nitazoxanide 500mg twice daily
Intervention Type
Drug
Intervention Name(s)
conventional interferon alfa
Other Intervention Name(s)
Inj uniferon 3 Million International Units
Intervention Description
Inj interferon 3 Million International Units thrice weekly
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
Ribavirin 400mg-1200mg
Intervention Description
ribazole
Primary Outcome Measure Information:
Title
Sustained Viral Response,
Description
Sustained viral response ,is negative Hepatitis C Virus(PCR)RNA test six months after end of treatment.
Time Frame
48 WEEK
Secondary Outcome Measure Information:
Title
Normalization of Alanine Transferase Test
Description
Liver function test,showing resolution of the inflammation of liver parenchyma
Time Frame
48week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
FAISAL MASUD, FRCP
Organizational Affiliation
Principal SIMS/Services hospital lahore
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
AMENA MIRZA, MRCP,FCPS
Organizational Affiliation
Senior registrar ,Services hospital lahore/SIMS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Madiha Fida, MBBS
Organizational Affiliation
House Officer Services Hospital Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Endocrinology and Diabetes management centre
City
Lahore
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

Learn more about this trial

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

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