Official Title
The Role Of Nitazoxanide, Interferon Alfa And Ribavirin In Treatment Of Hepatitis C Infected Type 2 Diabetic Patients
Phase
Phase 4Lead Sponsor
Services Institute of Medical Sciences, PakistanStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Hepatitis C, Chronic DIABETES MELLITUS Type 2Intervention/Treatment
nitazoxanide ribavirin interferon alpha-2b ...Study Participants
66The 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.
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.
nitazoxanide 500mg twice daily
Inj interferon 3 Million International Units thrice weekly
ribazole
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
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
| Event Type | Organ System | Event Term | Control Group | Study Group |
|---|
Sustained viral response ,is negative Hepatitis C Virus(PCR)RNA test six months after end of treatment.
Liver function test,showing resolution of the inflammation of liver parenchyma
