Status:
UNKNOWN
To Study the Efficacy and Safety of Renessans in Chronic HCV Patients
Lead Sponsor:
MTI Medical Private Limited, Pakistan
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
Brief Summary
Chronic HCV infection is one of the common causes of the chronic liver disease. Approximately 6-10% of the general public is expected to be suffering from this infection. In case that these patients a...
Detailed Description
1. Primary The primary objective of this study is to assess the efficacy of combination therapy comprising of RENESSANS, INTERFERONS and RIBAVIRIN in the management of treatment naïve HCV related ...
Eligibility Criteria
Inclusion
- Following groups of the people will be enrolled for the study.
- Patients suffering from chronic HCV infection as evident with a positive serology for Anti HCV antibody and raised ALT.
- Both males and females
- Age group: 18 - 55 years
- Informed consent
Exclusion
- Following groups of people will be excluded from the study
- Pregnant females
- Body mass index more than 25
- Uncontrolled Diabetes Mellitus, Hypertension, Ischemic heart disease, Renal failure, Respiratory failure, Chronic infections, gall stone disease or renal stone disease.
- Patients known to have hypersensitivity to Iodine compounds in the past.
- Psychiatric disorders except mild anxiety disorders.
- Patients suffering from auto immune diseases e.g. Rheumatoid Arthritis, SLE, or thyroid diseases.
- Patients suffering from concomitant HBV infection, HIV infection or any other chronic liver disease.
- Bilirubin more than 2mg/dl, Albumin less than 3.0 gms/dl, INR more than 1.5, Hb. less than 10 gms /dl, absolute neutrophil count less than 1500/cmm and platelet count less than 100,000/cmm
- Serum sodium less than 130mmol/l.
- Patients who have received the interferon treatment in the past.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01463592
Start Date
June 1 2010
End Date
December 1 2013
Last Update
November 22 2011
Active Locations (1)
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1
Medical Unit 1,Lahore General Hospital,Postgraduate Medical Institute
Lahore, Punjab Province, Pakistan, 42200