DIABETES MELLITUS Type 2, Hepatitis C, Chronic
Conditions
Keywords
Nitazoxanide,, Sustained viral response, Type 2 DIABETICS
Brief 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.
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.
Interventions
DRUGnitazoxanide
nitazoxanide 500mg twice daily
DRUGconventional interferon alfa
Inj interferon 3 Million International Units thrice weekly
DRUGRibavirin
ribazole
Sponsors
Getz Pharma
Services Institute of Medical Sciences, Pakistan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained Viral Response, | 48 WEEK | Sustained viral response ,is negative Hepatitis C Virus(PCR)RNA test six months after end of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Normalization of Alanine Transferase Test | 48week | Liver function test,showing resolution of the inflammation of liver parenchyma |
Countries
Pakistan
Participant flow
Recruitment details
Data was collected from diabetic patients coming to diabetes management center Services Hospital Lahore. Recruitment started on july 2011 and last patient was recruited in March 2012.
Pre-assignment details
Initially 153 patients were recruited but only 66 patients were enrolled in the trial based on our inclusion criteria. Following patients were excluded: * 33 because of HCV genotype other than 3 * 18 because of normal ALT * 9 with undetectable HCV PCR * 2 because of thyroid dysfunction * 25 were lost to follow up
Participants by arm
| Arm | Count |
|---|---|
| Control Group Injection conventional interferon alfa 3 Million International Units alternate days and capsule ribavirin 400mg-1200mg weekly for six months
Ribavirin : ribazole
conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly | 33 |
| 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
Ribavirin : ribazole
nitazoxanide : nitazoxanide 500mg twice daily
conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly | 33 |
| Total | 66 |
Baseline characteristics
| Characteristic | Study Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 33 Participants | 33 Participants | 66 Participants |
| Age Continuous | 47.21 years STANDARD_DEVIATION 5.464 | 47.30 years STANDARD_DEVIATION 6.07 | 47.26 years STANDARD_DEVIATION 5.73 |
| Region of Enrollment Pakistan | 33 participants | 33 participants | 66 participants |
| Sex: Female, Male Female | 14 Participants | 15 Participants | 29 Participants |
| Sex: Female, Male Male | 19 Participants | 18 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 33 / 33 | 33 / 33 |
| serious Total, serious adverse events | 2 / 33 | 3 / 33 |
Outcome results
Primary
Sustained Viral Response,
Sustained viral response ,is negative Hepatitis C Virus(PCR)RNA test six months after end of treatment.
Time frame: 48 WEEK
Population: Sample size has been calculated using Epi-Info 3.5.1 with the following assumptions.~Reported ETR with Interferon + Ribavarin = 44 % Expected ETR with Interferon + Ribavarin + Nitazoxanide = 80 % Confidence Level = 95 % Power of Study = 80% Calculated Sample Size = 66 i.e. 33 in each group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Group | Sustained Viral Response, | 13 participants |
| Study Group | Sustained Viral Response, | 11 participants |
Secondary
Normalization of Alanine Transferase Test
Liver function test,showing resolution of the inflammation of liver parenchyma
Time frame: 48week
Population: Sample size has been calculated using Epi-Info 3.5.1 with the following assumptions.~Reported ETR with Interferon + Ribavarin = 44 % Expected ETR with Interferon + Ribavarin + Nitazoxanide = 80 % Confidence Level = 95 % Power of Study = 80% Calculated Sample Size = 66 i.e. 33 in each group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Group | Normalization of Alanine Transferase Test | 11 participants |
| Study Group | Normalization of Alanine Transferase Test | 11 participants |