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

Services Institute of Medical Sciences, Pakistan

Status and phase: Completed; Phase 4

Conditions: Hepatitis C, Chronic; DIABETES MELLITUS Type 2

Treatments: Drug: nitazoxanide; Drug: Ribavirin; Drug: conventional interferon alfa

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01770483

SIMS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 35 to 55 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

study group

Experimental group

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

Treatment:

Drug: conventional interferon alfa

Drug: Ribavirin

Drug: nitazoxanide

control group

Active Comparator group

Description:

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

Treatment:

Drug: conventional interferon alfa

Drug: Ribavirin