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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03170076
Other study ID # skin manifestations in HCV
Secondary ID
Status Not yet recruiting
Phase N/A
First received May 24, 2017
Last updated May 26, 2017
Start date July 2017
Est. completion date July 2018

Study information

Verified date May 2017
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 .


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 .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1
Est. completion date July 2018
Est. primary completion date July 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (4)

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. Epub 2006 Aug 17. Review. Erratum in: Clin Gastroenterol Hepatol. 2007 Jun;5(6):765. — View Citation

Cacoub P, Bourlière M, Lübbe J, Dupin N, Buggisch P, Dusheiko G, Hézode 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. Review. — View Citation

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. Review. — View Citation

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. Erratum in: Hepatology. 2004 Jul;40(1):269. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary local skin examination examination of skin manifestations in patients with hepatitis c under treatment with direct acting anti viral drugs three months
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