Phase 4
Completed N=66
The Role Of Nitazoxanide, Interferon Alfa And Ribavirin In Treatment Of Hepatitis C Infected Type 2 Diabetic Patients
Hepatitis C, Chronic · Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT01770483 ↗
Enrolled (actual)
66
Serious AEs
7.6%
Results posted
Apr 2013
Primary outcomePrimary: Sustained Viral Response, — 13; 11 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sustained Viral Response, |
13; 11 | — |
| SECONDARY Normalization of Alanine Transferase Test |
11; 11 | — |
Eligibility Criteria
Inclusion Criteria
- Hepatitis C genotype 3a
- Hepatitis C Virus(PCR)RNA Detected
- Alanine transaminase >60
- Diabetic HbA1c 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
Data sourced from ClinicalTrials.gov (NCT01770483). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.