Pattern of Skin Manifestations in Chronic Hepatitis c Virus Patients Before and After Direct Acting Anti Viral Drugs

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03170076
Collaborator
(none)
1
12

Study Details

Study Description

Brief Summary

  • Hepatitis C is an infectious disease caused by the hepatitis C virus (HCV) that primarily affects the liver. It is one of the main causes of chronic liver diseases worldwide .

  • According to World Health Organization (WHO), 2011 , Egypt has particularly high rates of Hepatitis C (22%).

  • Hepatitis C virus (HCV) is known to induce both hepatic and extra-hepatic manifestations. About 17% of HCV patients present with at least one skin manifestation, which can be directly or indirectly induced by chronic HCV infection .

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    • Skin diseases which are certainly related with chronic HCV infection are mixed cryoglobulinemia, lichen planus , porphyria cutanea tarda, Chronic pruritus and necrolytic acral erythema; conditions that may share a possible association with HCV infection .

    • while several immune-mediated inflammatory skin conditions, such as psoriasis, chronic urticaria and vitiligo, have been only rarely reported in the setting of chronic HCV infection .

    • Peginterferon based regimen with or without ribavirin were the mainstay of HCV treatment with a cure rate of about 50%, Although these regimens were lengthy, complex, had significant side-effects and high failure rates .

    • They also had higher rate of exacerbated dermatologic conditions such as discoid lupus, psoriasis and Lichen planus .

    • Recently, Newer all-oral anti viral drugs regimens began to be approved for use in 2014. These regimens, involve one pill daily for 12 weeks, they have achieved sustained virologic response of over 90% and have more tolerable side effect profiles.

    • Recently, The European Association for Study of Liver (EASL) 2015, American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA) have now recommended that all chronically infected HCV patient should be offered treatment with new oral antiviral drugs .

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Pattern of Skin Manifestations in Chronic Hepatitis c Virus Patients Before and After Direct Acting Anti Viral Drugs: Prospective Controlled Clinical Trial
    Anticipated Study Start Date :
    Jul 1, 2017
    Anticipated Primary Completion Date :
    Jul 1, 2018
    Anticipated Study Completion Date :
    Jul 1, 2018

    Outcome Measures

    Primary Outcome Measures

    1. local skin examination [three months]

      examination of skin manifestations in patients with hepatitis c under treatment with direct acting anti viral drugs

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Patients with HCV infection eligible for treatment with new (DAADs) and having:

    A- Normal Complete Blood Count ( hemoglobin not less than 10 gm/dl ). B- Mild to moderate impairment of Liver function test and kidney function test.

    C- Positive polymerase chain reaction for HCV virus. D- Controlled Blood sugar .

    1. Patients > 18 years
    Exclusion Criteria:
    1. Patients on treatment for skin disease.

    2. Pregnancy and lactation.

    3. Patients <18 years.

    4. Patients not eligible for oral anti hepatitis C drugs.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Hagar Maher, Dermatologic resident, Assiut University
    ClinicalTrials.gov Identifier:
    NCT03170076
    Other Study ID Numbers:
    • skin manifestations in HCV
    First Posted:
    May 30, 2017
    Last Update Posted:
    May 30, 2017
    Last Verified:
    May 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hagar Maher, Dermatologic resident, Assiut University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 30, 2017