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

NCT ID: NCT03170076

Last Updated: 2017-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-31

Study Completion Date

2018-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

* 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 .

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

* 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 .

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatitis C, Chronic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hagar Maher

Dermatologic resident

Responsibility Role PRINCIPAL_INVESTIGATOR

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 26162860 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16919505 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15057920 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21884670 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

skin manifestations in HCV

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Metformin Therapy in HCV Infection
NCT02972723 COMPLETED PHASE4