Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03170076
Recruitment Status : Not yet recruiting
First Posted : May 30, 2017
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Hagar Maher, Assiut University

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
Hepatitis C, Chronic

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 .

Layout table for study information
Study Type : Observational
Estimated 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
Estimated Study Start Date : July 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. local skin examination [ Time Frame: three months ]
    examination of skin manifestations in patients with hepatitis c under treatment with direct acting anti viral drugs



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:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all patient are from assiut city
Criteria

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 .

  2. 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.

Publications:
Layout table for additonal information
Responsible Party: Hagar Maher, Dermatologic resident, Assiut University
ClinicalTrials.gov Identifier: NCT03170076     History of Changes
Other Study ID Numbers: skin manifestations in HCV
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 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

Keywords provided by Hagar Maher, Assiut University:
skin manifestations - hepatitis c virus

Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Hepatitis, Viral, Human
Skin Manifestations
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Signs and Symptoms
Antiviral Agents
Anti-Infective Agents