Impact of Interleukin 28B (rs12979860) Genotype on Virological Responses Chronic Hepatitis C Treatment
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ClinicalTrials.gov Identifier: NCT03090035 |
Recruitment Status :
Completed
First Posted : March 24, 2017
Last Update Posted : April 25, 2017
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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 |
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Hepatitis C Hepatitis C Relapse | Drug: Pegylated Interferon α2 Drug: Ribavirin | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 98 participants |
Allocation: | N/A |
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 |

Arm | Intervention/treatment |
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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
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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 |
- Treatment Success rate [ Time Frame: after 24 weeks of treatment ]Treatment Success rate (End Treatment Response) was noted to check the adequency of treatment
- Sustained Virological Response [ Time Frame: After 48 weeks of treament ]Sustained Virological Response was noted to check treatment success after extended period
- Relapse Rate [ Time Frame: After 48 weeks of treament ]Relapse Rate to check re-occurrence of Hepatitis infection

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Ages Eligible for Study: | 20 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- patients with diagnosis of chronic hepatitis C genotype 2 or 3
Exclusion Criteria:
- Patients with hepatitis genotype I and IV

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
Pakistan | |
Muhammad Zafar Majeed Babar | |
Sadiqabad, Punjab, Pakistan, 64200 |
Principal Investigator: | Muhammad ZM Babar, FCPS | Sheikh Zayed Medical College/Hospital |
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 |
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 |
HCV genotype 2, HCV genotype 3, IL-28B, PEG-INF. |
Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Infections Enterovirus Infections Picornaviridae Infections RNA Virus Infections |
Blood-Borne Infections Communicable Diseases Flaviviridae Infections Hepatitis, Chronic Interferons Ribavirin Antineoplastic Agents Antiviral Agents Anti-Infective Agents Antimetabolites Molecular Mechanisms of Pharmacological Action |