HEP-C-FM: The Role Of Nitazoxanide, Interferon Alfa And Ribavirin In Treatment Of Hepatitis C Infected Type 2 Diabetic Patients

• Sponsor: Services Institute of Medical Sciences, Pakistan (Other)
• Overall Status: Completed
• CT.gov ID: NCT01770483
• Collaborator: Getz Pharma (Industry)
• Enrollment: 66
• Location: 1
• Arms: 2
• Duration (Months): 20
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C, Chronic; DIABETES MELLITUS Type 2	Drug: nitazoxanide; Drug: conventional interferon alfa; Drug: Ribavirin	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Role Of Nitazoxanide, Interferon Alfa And Ribavirin In Treatment Of Hepatitis C Infected Type 2 Diabetic Patients
• Study Start Date: Jul 1, 2011
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: nitazoxanide; nitazoxanide 500mg twice daily; Other Names: tablet nizonide500mg tablet atizox500mg ; Drug: conventional interferon alfa; Inj interferon 3 Million International Units thrice weekly; Other Names: Inj uniferon 3 Million International Units ; Drug: Ribavirin; ribazole; Other Names: Ribavirin 400mg-1200mg
Active Comparator: control group Injection conventional interferon alfa 3 Million International Units alternate days and capsule ribavirin 400mg-1200mg weekly for six months	Drug: conventional interferon alfa; Inj interferon 3 Million International Units thrice weekly; Other Names: Inj uniferon 3 Million International Units ; Drug: Ribavirin; ribazole; Other Names: Ribavirin 400mg-1200mg

Outcome Measures

Primary Outcome Measures

1. Sustained Viral Response, [48 WEEK]

   Sustained viral response ,is negative Hepatitis C Virus(PCR)RNA test six months after end of treatment.

Secondary Outcome Measures

1. Normalization of Alanine Transferase Test [48week]

   Liver function test,showing resolution of the inflammation of liver parenchyma

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Endocrinology and Diabetes management centre	Lahore	Punjab	Pakistan

Sponsors and Collaborators

• Services Institute of Medical Sciences, Pakistan
• Getz Pharma

Investigators

• Study Director: FAISAL MASUD, FRCP, Principal SIMS/Services hospital lahore
• Principal Investigator: AMENA MIRZA, MRCP,FCPS, Senior registrar ,Services hospital lahore/SIMS
• Principal Investigator: Madiha Fida, MBBS, House Officer Services Hospital Lahore

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prof. Faisal Masud, Principal SIMS, Services Institute of Medical Sciences, Pakistan
• ClinicalTrials.gov Identifier: NCT01770483
• Other Study ID Numbers: SIMS
• First Posted: Jan 17, 2013
• Last Update Posted: Sep 20, 2013
• Last Verified: Sep 1, 2013

• Keywords provided by Prof. Faisal Masud, Principal SIMS, Services Institute of Medical Sciences, Pakistan: Nitazoxanide,; Sustained viral response; Type 2 DIABETICS
• Additional relevant MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Diabetes Mellitus, Type 2; Interferons; Ribavirin; Interferon-alpha; Nitazoxanide

Study Results

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 Detail	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

Arm/Group Title	Control Group	Study Group
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	33	33
COMPLETED	33	33
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Control Group	Study Group	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	33	33	66
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	33 100%	33 100%	66 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.30 (6.07)	47.21 (5.464)	47.26 (5.73)
Sex: Female, Male (Count of Participants)
Female	15 45.5%	14 42.4%	29 43.9%
Male	18 54.5%	19 57.6%	37 56.1%
Region of Enrollment (participants) [Number]
Pakistan	33 100%	33 100%	66 100%

Outcome Measures

1. Primary Outcome

Title	Sustained Viral Response,
Description	Sustained viral response ,is negative Hepatitis C Virus(PCR)RNA test six months after end of treatment.
Time Frame	48 WEEK

Outcome Measure Data

Analysis Population Description

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/Group Title	Control Group	Study Group
Arm/Group Description	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	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
Measure Participants	33	33
Number [participants]	13 39.4%	11 33.3%

2. Secondary Outcome

Title	Normalization of Alanine Transferase Test
Description	Liver function test,showing resolution of the inflammation of liver parenchyma
Time Frame	48week

Outcome Measure Data

Analysis Population Description

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/Group Title	Control Group	Study Group
Arm/Group Description	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	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
Measure Participants	33	33
Number [participants]	11 33.3%	11 33.3%

Adverse Events

Time Frame	1 year and 8 months
Arm/Group Title	Control Group		Study Group
Arm/Group Description	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		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
All Cause Mortality
	Control Group		Study Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Control Group		Study Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/33 (6.1%)		3/33 (9.1%)
Blood and lymphatic system disorders
hemolysis	1/33 (3%)	1	0/33 (0%)	0
Hepatobiliary disorders
Acute hepatitis	0/33 (0%)	0	2/33 (6.1%)	2
Infections and infestations
diabetic foot	1/33 (3%)	1	0/33 (0%)	0
Psychiatric disorders
Depression	0/33 (0%)	0	1/33 (3%)	1
Other (Not Including Serious) Adverse Events
	Control Group		Study Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	33/33 (100%)		33/33 (100%)
Gastrointestinal disorders
Diarrhea	0/33 (0%)	0	6/33 (18.2%)	6
Nausea	16/33 (48.5%)	16	23/33 (69.7%)	23
Respiratory, thoracic and mediastinal disorders
Flu	29/33 (87.9%)	29	29/33 (87.9%)	29
Dry Cough	1/33 (3%)	1	2/33 (6.1%)	2
Skin and subcutaneous tissue disorders
Alopecia	0/33 (0%)	0	2/33 (6.1%)	2
Rash	0/33 (0%)	0	2/33 (6.1%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.