Trial Outcomes & Findings for The Role Of Nitazoxanide, Interferon Alfa And Ribavirin In Treatment Of Hepatitis C Infected Type 2 Diabetic Patients (NCT NCT01770483)
NCT ID: NCT01770483
Last Updated: 2013-09-20
Results Overview
Sustained viral response ,is negative Hepatitis C Virus(PCR)RNA test six months after end of treatment.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
66 participants
Primary outcome timeframe
48 WEEK
Results posted on
2013-09-20
Participant Flow
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.
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
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
|
Overall Study
COMPLETED
|
33
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Role Of Nitazoxanide, Interferon Alfa And Ribavirin In Treatment Of Hepatitis C Infected Type 2 Diabetic Patients
Baseline characteristics by cohort
| Measure |
Control Group
n=33 Participants
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
|
Study Group
n=33 Participants
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
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
47.30 years
STANDARD_DEVIATION 6.07 • n=5 Participants
|
47.21 years
STANDARD_DEVIATION 5.464 • n=7 Participants
|
47.26 years
STANDARD_DEVIATION 5.73 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Region of Enrollment
Pakistan
|
33 participants
n=5 Participants
|
33 participants
n=7 Participants
|
66 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 WEEKPopulation: 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.
Sustained viral response ,is negative Hepatitis C Virus(PCR)RNA test six months after end of treatment.
Outcome measures
| Measure |
Control Group
n=33 Participants
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
|
Study Group
n=33 Participants
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
|
|---|---|---|
|
Sustained Viral Response,
|
13 participants
|
11 participants
|
SECONDARY outcome
Timeframe: 48weekPopulation: 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.
Liver function test,showing resolution of the inflammation of liver parenchyma
Outcome measures
| Measure |
Control Group
n=33 Participants
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
|
Study Group
n=33 Participants
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
|
|---|---|---|
|
Normalization of Alanine Transferase Test
|
11 participants
|
11 participants
|
Adverse Events
Control Group
Serious events: 2 serious events
Other events: 33 other events
Deaths: 0 deaths
Study Group
Serious events: 3 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control Group
n=33 participants at risk
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
|
Study Group
n=33 participants at risk
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
|
|---|---|---|
|
Blood and lymphatic system disorders
hemolysis
|
3.0%
1/33 • Number of events 1 • 1 year and 8 months
|
0.00%
0/33 • 1 year and 8 months
|
|
Infections and infestations
diabetic foot
|
3.0%
1/33 • Number of events 1 • 1 year and 8 months
|
0.00%
0/33 • 1 year and 8 months
|
|
Hepatobiliary disorders
Acute hepatitis
|
0.00%
0/33 • 1 year and 8 months
|
6.1%
2/33 • Number of events 2 • 1 year and 8 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/33 • 1 year and 8 months
|
3.0%
1/33 • Number of events 1 • 1 year and 8 months
|
Other adverse events
| Measure |
Control Group
n=33 participants at risk
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
|
Study Group
n=33 participants at risk
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
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/33 • 1 year and 8 months
|
6.1%
2/33 • Number of events 2 • 1 year and 8 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/33 • 1 year and 8 months
|
6.1%
2/33 • Number of events 2 • 1 year and 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Flu
|
87.9%
29/33 • Number of events 29 • 1 year and 8 months
|
87.9%
29/33 • Number of events 29 • 1 year and 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Dry Cough
|
3.0%
1/33 • Number of events 1 • 1 year and 8 months
|
6.1%
2/33 • Number of events 2 • 1 year and 8 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/33 • 1 year and 8 months
|
18.2%
6/33 • Number of events 6 • 1 year and 8 months
|
|
Gastrointestinal disorders
Nausea
|
48.5%
16/33 • Number of events 16 • 1 year and 8 months
|
69.7%
23/33 • Number of events 23 • 1 year and 8 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place