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

This study has been completed.
Sponsor:
Collaborator:
Getz Pharma
Information provided by (Responsible Party):
Prof. Faisal Masud, Services Institute of Medical Sciences, Pakistan
ClinicalTrials.gov Identifier:
NCT01770483
First received: January 8, 2013
Last updated: September 15, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Hepatitis C, Chronic
DIABETES MELLITUS Type 2
Drug: nitazoxanide
Drug: conventional interferon alfa
Drug: Ribavirin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Services Institute of Medical Sciences, Pakistan:

Primary Outcome Measures:
  • Sustained Viral Response, [ Time Frame: 48 WEEK ] [ Designated as safety issue: No ]
    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 [ Time Frame: 48week ] [ Designated as safety issue: No ]
    Liver function test,showing resolution of the inflammation of liver parenchyma


Enrollment: 66
Study Start Date: July 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   35 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01770483

Locations
Pakistan
Endocrinology and Diabetes management centre
Lahore, Punjab, Pakistan
Sponsors and Collaborators
Services Institute of Medical Sciences, Pakistan
Getz Pharma
Investigators
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

No publications provided

Responsible Party: Prof. Faisal Masud, Principal SIMS, Services Institute of Medical Sciences, Pakistan
ClinicalTrials.gov Identifier: NCT01770483     History of Changes
Other Study ID Numbers: SIMS
Study First Received: January 8, 2013
Results First Received: March 7, 2013
Last Updated: September 15, 2013
Health Authority: Pakistan: Research Ethics Committee

Keywords provided by Services Institute of Medical Sciences, Pakistan:
Nitazoxanide,
Sustained viral response
Type 2 DIABETICS

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Diabetes Mellitus
Hepatitis C
Hepatitis C, Chronic
Diabetes Mellitus, Type 2
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Flaviviridae Infections
Hepatitis, Chronic
Interferons
Ribavirin
Interferon-alpha
Nitazoxanide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors

ClinicalTrials.gov processed this record on October 16, 2014