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

Hepatitis C, Chronic Clinical Trial

— HEP-C-FM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01770483
• Other study ID #: SIMS
• Status: Completed
• Phase: Phase 4
• First received: January 8, 2013
• Last updated: September 15, 2013
• Start date: July 2011
• Est. completion date: March 2013

Study information

• Verified date: September 2013
• Source: Services Institute of Medical Sciences, Pakistan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• DIABETES MELLITUS Type 2
• Diabetes Mellitus, Type 2
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• nitazoxanide
nitazoxanide 500mg twice daily
• conventional interferon alfa
Inj interferon 3 Million International Units thrice weekly
• Ribavirin
ribazole

Locations

Country	Name	City	State
Pakistan	Endocrinology and Diabetes management centre	Lahore	Punjab

Sponsors (2)

Lead Sponsor	Collaborator
Services Institute of Medical Sciences, Pakistan	Getz Pharma

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained Viral Response,	Sustained viral response ,is negative Hepatitis C Virus(PCR)RNA test six months after end of treatment.	48 WEEK	No
Secondary	Normalization of Alanine Transferase Test	Liver function test,showing resolution of the inflammation of liver parenchyma	48week	No