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| Name | Class |
|---|---|
| Getz Pharma | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group | Experimental | 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 |
|
| control group | Active Comparator | Injection conventional interferon alfa 3 Million International Units alternate days and capsule ribavirin 400mg-1200mg weekly for six months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nitazoxanide | Drug | nitazoxanide 500mg twice daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Sustained Viral Response, | Sustained viral response ,is negative Hepatitis C Virus(PCR)RNA test six months after end of treatment. | 48 WEEK |
| Measure | Description | Time Frame |
|---|---|---|
| Normalization of Alanine Transferase Test | Liver function test,showing resolution of the inflammation of liver parenchyma | 48week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| FAISAL MASUD, FRCP | Principal SIMS/Services hospital lahore | Study Director |
| AMENA MIRZA, MRCP,FCPS | Senior registrar ,Services hospital lahore/SIMS | Principal Investigator |
| Madiha Fida, MBBS | House Officer Services Hospital Lahore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endocrinology and Diabetes management centre | Lahore | Punjab Province | Pakistan |
Initially 153 patients were recruited but only 66 patients were enrolled in the trial based on our inclusion criteria. Following patients were excluded:
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Study Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| conventional interferon alfa | Drug | Inj interferon 3 Million International Units thrice weekly |
|
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| Ribavirin | Drug | ribazole |
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|
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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sustained Viral Response, | Sustained viral response ,is negative Hepatitis C Virus(PCR)RNA test six months after end of treatment. | 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. | Posted | Number | participants | 48 WEEK |
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| Secondary | Normalization of Alanine Transferase Test | Liver function test,showing resolution of the inflammation of liver parenchyma | 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. | Posted | Number | participants | 48week |
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1 year and 8 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 2 | 33 | 33 | 33 | ||
| EG001 | 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 | 3 | 33 | 33 | 33 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hemolysis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| diabetic foot | Infections and infestations | Systematic Assessment |
| ||
| Acute hepatitis | Hepatobiliary disorders | Systematic Assessment |
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| Depression | Psychiatric disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alopecia | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Flu | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dry Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Faisal Masud | SIMS | 00923004260213 | faisalmasud@hotmail.com |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C041747 | nitazoxanide |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| >=65 years |
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| Male |
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| Participants |
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