Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Impact of Interleukin 28B (rs12979860) Genotype on Virological Responses Chronic Hepatitis C Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03090035
Recruitment Status : Completed
First Posted : March 24, 2017
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
Sheikh Zayed Medical College

Brief Summary:

Objective:

Pegulated Interferon α2 plus ribavirin is a treatment of choice in patients with chronic hepatitis C infection. This study was conducted to find out the frequency of different IL-28B (rs12979860) genotypes in patients with chronic hepatitis C (HCV genotype type 2 & 3) infection treated with Pegulated Interferon α2 plus ribavirin and to evaluate the role of IL-28B genotypes in achieving Sustained Virological Response (SVR).

Methods:

In this non-randomized observational study, ninety eight (98) patients with diagnosis of chronic hepatitis C were included. In all patients, Peg-IFN plus Ribavirin were given in standard doses for 24 weeks. End treatment response, sustained virological response, and relapse rate were the primary endpoints of this study. Analysis of IL28B (rs12979860) polymorphism (CC, CT and TT) was performed by PCR-RFLP protocol.


Condition or disease Intervention/treatment Phase
Hepatitis C Hepatitis C Relapse Drug: Pegylated Interferon α2 Drug: Ribavirin Phase 3

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Interleukin 28B (rs12979860) Genotype on Virological Responses in Chronic Hepatitis C Treatment
Actual Study Start Date : January 1, 2014
Actual Primary Completion Date : July 1, 2014
Actual Study Completion Date : December 31, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: chronic hepatitis C genotype 2 or 3
In all patients Pegylated Interferon α2 (pegIFN) plus Ribavirin were given in standard doses. Peg-INF was given in a dose of 180 μg/week and ribavirin 1200 mg/day to every patient for the period of 24 weeks for HCV genotype 2 & 3
Drug: Pegylated Interferon α2
Peg-INF was given in a dose of 180 μg/week
Other Name: Unipg

Drug: Ribavirin
ribavirin 1200 mg/day to every patient for the period of 24 weeks for HCV genotype 2 & 3
Other Name: Ribavil




Primary Outcome Measures :
  1. Treatment Success rate [ Time Frame: after 24 weeks of treatment ]
    Treatment Success rate (End Treatment Response) was noted to check the adequency of treatment


Secondary Outcome Measures :
  1. Sustained Virological Response [ Time Frame: After 48 weeks of treament ]
    Sustained Virological Response was noted to check treatment success after extended period

  2. Relapse Rate [ Time Frame: After 48 weeks of treament ]
    Relapse Rate to check re-occurrence of Hepatitis infection



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with diagnosis of chronic hepatitis C genotype 2 or 3

Exclusion Criteria:

  • Patients with hepatitis genotype I and IV

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090035


Locations
Layout table for location information
Pakistan
Muhammad Zafar Majeed Babar
Sadiqabad, Punjab, Pakistan, 64200
Sponsors and Collaborators
Sheikh Zayed Medical College
Investigators
Layout table for investigator information
Principal Investigator: Muhammad ZM Babar, FCPS Sheikh Zayed Medical College/Hospital

Publications of Results:

Layout table for additonal information
Responsible Party: Sheikh Zayed Medical College
ClinicalTrials.gov Identifier: NCT03090035    
Other Study ID Numbers: sheikhZMC
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sheikh Zayed Medical College:
HCV genotype 2, HCV genotype 3, IL-28B, PEG-INF.
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Interferons
Ribavirin
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action