NCT03170076

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 .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2017

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

1 year

First QC Date

May 24, 2017

Last Update Submit

May 26, 2017

Conditions

Keywords

skin manifestations - hepatitis c virus

Outcome Measures

Primary Outcomes (1)

  • local skin examination

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

    three months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all patient are from assiut city

You may qualify if:

  • 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 .
  • Patients \> 18 years

You may not qualify if:

  • Patients on treatment for skin disease.
  • Pregnancy and lactation.
  • Patients \<18 years.
  • Patients not eligible for oral anti hepatitis C drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Patel P, Malik K, Krishnamurthy K. Cutaneous Adverse Events in Chronic Hepatitis C Patients Treated With New Direct-Acting Antivirals: A Systematic Review and Meta-Analysis. J Cutan Med Surg. 2016 Jan;20(1):58-66. doi: 10.1177/1203475415595775. Epub 2015 Jul 10.

    PMID: 26162860BACKGROUND
  • Berk DR, Mallory SB, Keeffe EB, Ahmed A. Dermatologic disorders associated with chronic hepatitis C: effect of interferon therapy. Clin Gastroenterol Hepatol. 2007 Feb;5(2):142-51. doi: 10.1016/j.cgh.2006.06.010. Epub 2006 Aug 17.

    PMID: 16919505BACKGROUND
  • Strader DB, Wright T, Thomas DL, Seeff LB; American Association for the Study of Liver Diseases. Diagnosis, management, and treatment of hepatitis C. Hepatology. 2004 Apr;39(4):1147-71. doi: 10.1002/hep.20119. No abstract available.

    PMID: 15057920BACKGROUND
  • Cacoub P, Bourliere M, Lubbe J, Dupin N, Buggisch P, Dusheiko G, Hezode C, Picard O, Pujol R, Segaert S, Thio B, Roujeau JC. Dermatological side effects of hepatitis C and its treatment: patient management in the era of direct-acting antivirals. J Hepatol. 2012 Feb;56(2):455-63. doi: 10.1016/j.jhep.2011.08.006. Epub 2011 Aug 30.

    PMID: 21884670BACKGROUND

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dermatologic resident

Study Record Dates

First Submitted

May 24, 2017

First Posted

May 30, 2017

Study Start

July 1, 2017

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

May 30, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share