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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01770483
Recruitment Status : Completed
First Posted : January 17, 2013
Results First Posted : April 17, 2013
Last Update Posted : September 20, 2013
Sponsor:
Collaborator:
Getz Pharma
Information provided by (Responsible Party):
Prof. Faisal Masud, Services Institute of Medical Sciences, Pakistan

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic DIABETES MELLITUS Type 2 Drug: nitazoxanide Drug: conventional interferon alfa Drug: Ribavirin Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Role Of Nitazoxanide, Interferon Alfa And Ribavirin In Treatment Of Hepatitis C Infected Type 2 Diabetic Patients
Study Start Date : July 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 Drug: nitazoxanide
nitazoxanide 500mg twice daily
Other Names:
  • tablet nizonide500mg
  • tablet atizox500mg

Drug: conventional interferon alfa
Inj interferon 3 Million International Units thrice weekly
Other Name: Inj uniferon 3 Million International Units

Drug: Ribavirin
ribazole
Other Name: Ribavirin 400mg-1200mg
Active Comparator: control group
Injection conventional interferon alfa 3 Million International Units alternate days and capsule ribavirin 400mg-1200mg weekly for six months
 Drug: conventional interferon alfa
Inj interferon 3 Million International Units thrice weekly
Other Name: Inj uniferon 3 Million International Units

Drug: Ribavirin
ribazole
Other Name: Ribavirin 400mg-1200mg


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Normalization of Alanine Transferase Test [ Time Frame: 48week ]
    Liver function test,showing resolution of the inflammation of liver parenchyma


Eligibility Criteria
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Ages Eligible for Study:   35 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01770483


Locations
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Pakistan
Endocrinology and Diabetes management centre
Lahore, Punjab, Pakistan
Sponsors and Collaborators
Services Institute of Medical Sciences, Pakistan
Getz Pharma
Investigators
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Study Director: FAISAL MASUD, FRCP Principal SIMS/Services hospital lahore
Principal Investigator: AMENA MIRZA, MRCP,FCPS Senior registrar ,Services hospital lahore/SIMS
Principal Investigator: Madiha Fida, MBBS House Officer Services Hospital Lahore
More Information
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Responsible Party: Prof. Faisal Masud, Principal SIMS, Services Institute of Medical Sciences, Pakistan
ClinicalTrials.gov Identifier: NCT01770483    
Other Study ID Numbers: SIMS
First Posted: January 17, 2013    Key Record Dates
Results First Posted: April 17, 2013
Last Update Posted: September 20, 2013
Last Verified: September 2013
Keywords provided by Prof. Faisal Masud, Services Institute of Medical Sciences, Pakistan:
Nitazoxanide,
Sustained viral response
Type 2 DIABETICS
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Diabetes Mellitus, Type 2
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
 Flaviviridae Infections
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hepatitis, Chronic
Interferons
Ribavirin
Interferon-alpha
Nitazoxanide
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action