NCT01770483

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 17, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
2 months until next milestone

Results Posted

Study results publicly available

April 17, 2013

Completed
Last Updated

September 20, 2013

Status Verified

September 1, 2013

Enrollment Period

1.7 years

First QC Date

January 8, 2013

Results QC Date

March 7, 2013

Last Update Submit

September 15, 2013

Conditions

Hepatitis C, ChronicDIABETES MELLITUS Type 2

Keywords

Nitazoxanide,Sustained viral responseType 2 DIABETICS

Outcome Measures

Primary Outcomes (1)

  • Sustained Viral Response,

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

    48 WEEK

Secondary Outcomes (1)

  • Normalization of Alanine Transferase Test

    48week

Study Arms (2)

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

Drug: nitazoxanideDrug: conventional interferon alfaDrug: Ribavirin

control group

ACTIVE COMPARATOR

Injection conventional interferon alfa 3 Million International Units alternate days and capsule ribavirin 400mg-1200mg weekly for six months

Drug: conventional interferon alfaDrug: Ribavirin

Interventions

nitazoxanideDRUG

nitazoxanide 500mg twice daily

Also known as: tablet nizonide500mg, tablet atizox500mg
study group
conventional interferon alfaDRUG

Inj interferon 3 Million International Units thrice weekly

Also known as: Inj uniferon 3 Million International Units
control groupstudy group
RibavirinDRUG

ribazole

Also known as: Ribavirin 400mg-1200mg
control groupstudy group

Eligibility Criteria

Age35 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Hepatitis C genotype 3a
  • Hepatitis C Virus(PCR)RNA Detected
  • Alanine transaminase \>60
  • Diabetic HbA1c\<8
  • BMI\>23

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endocrinology and Diabetes management centre

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Hepatitis C, ChronicDiabetes Mellitus, Type 2

Interventions

nitazoxanideRibavirin

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

Title
Prof. Faisal Masud
Organization
SIMS
faisalmasud@hotmail.com
00923004260213

Study Officials

  • 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

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal SIMS

Study Record Dates

First Submitted

January 8, 2013

First Posted

January 17, 2013

Study Start

July 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

September 20, 2013

Results First Posted

April 17, 2013

Record last verified: 2013-09

Locations

PA(1)