Clinical trial NCT02261662: Off-Label Use of Ribavirin in Management of Mucocutaneous Extrahepatic Manifestations of HCV Infection
Official title: Randomized Controlled Study of Off-Label Use of Ribavirin in Management of Mucocutaneous Extrahepatic Manifestations of HCV Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatitis C
Lichen Planus
Vasculitis
Autoimmune Diseases
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2014-10-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be conducted on 30 patients with mucocutaneous complaints and documented HCV infection. The study will be done at Tropical medicine department , Tanta university. It will be conducted between June2014 and November 2014.

The aim of the study is to assess efficacy of Ribavirin in the management of mucocutaneous extrahepatic manifestations of HCV infection.

Detailed description: Hepatitis C virus is a common cause of chronic liver disease worldwide and represent public health problem. The Egyptian Demographic Health Survey (EDHS), a cross sectional survey including hepatitis C virus (HCV) biomarkers, was conducted in 2008 on a large nationally representative sample. It estimated HCV prevalence among the 15-59 years age group to be 14.7% . Accordingly, Egypt has the highest HCV prevalence in the world.

Although HCV is a hepatotropic virus, in some patients the primary manifestations of infection occur outside the liver. There is a growing body of evidence to support the idea that HCV can replicate efficiently in extrahepatic tissues including the Peripheral blood mononuclear cells (PBMC). Autoimmune manifestations are common in patients chronically infected by HCV . These manifestations can be dominant, whereas the hepatic disease can be quiescent or mild. More recently, there has been growing interest in the relationship between HCV and Sjogren's syndrome (SS), rheumatoid arthritis (RA), and systemic lupus erythematosus (SLE).

Of those , this article is interested in cutaneous and mucous membrane manifestations where many reports have shown that cutaneous manifestations are often the first signs of chronic HCV infection and these are indicated in 20-40% of the patients presenting to the dermatology clinics, therefore dermatologists must be aware of skin disorders associated with viral infection. The most commonly encountered dermatological manifestations of HCV infection includes mixed cryoglobulinemia (MC), porphyria cutanea tarda (PCT), cutaneous and/or oral lichen planus (LP), urticaria, pruritus, thrombocytopenic purpura and cutaneous vasculitis. Although majority of skin manifestations of chronic HCV infection represent the clinical impression of autoimmune phenomena, however, precise pathogenesis of these extra-hepatic complications is not well understood.

The aim of the study is to assess efficacy of Ribavirin in the management of mucocutaneous extrahepatic manifestations of HCV infection

This study will be conducted on 30 patients with mucocutaneous complaints and documented HCV infection. The study will be done at Tropical medicine department , Tanta university. It will be conducted between June2014 and November 2014.

Eligibility criteria: Inclusion Criteria:

* Patients with evidence of HCV infection and mucocutaneous complaint and contraindicated to have standard antiviral therapy.

Exclusion Criteria:

* Hypersensitivity to Ribavirin
* Pregnant \& Lactating women
* Male partners of pregnant women

Primary outcomes:
measure: Percentage of participants with improved skin manifestations of HCV infection after taking Ribavirin compared with topical steroids.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospital
state: Gharbia
Study officials:
affiliation: Tanta Faculty of Medicine, Professor
name: Asem A Elfert, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tanta Faculty of Medicine, Professor
name: Fat-heya E Assel, MD
role: STUDY_DIRECTOR
affiliation: Dr.
name: Mohamed Y Rabei
role: STUDY_DIRECTOR
affiliation: Dr.
name: Islam S Ismail
role: STUDY_DIRECTOR
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