Off-Label Use of Ribavirin in Management of Mucocutaneous Extrahepatic Manifestations of HCV Infection
Information source: Tanta University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis C; Lichen Planus; Vasculitis; Autoimmune Diseases
Intervention: Ribavirin (Drug); Betamethasone (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Tanta University Official(s) and/or principal investigator(s): Asem A Elfert, MD, Principal Investigator, Affiliation: Tanta Faculty of Medicine, Professor Fat-heya E Assel, MD, Study Director, Affiliation: Tanta Faculty of Medicine, Professor Mohamed Y Rabei, Study Director, Affiliation: Dr. Islam S Ismail, Study Director, Affiliation: Dr.
Overall contact: Asem A Elfert, MD, Phone: +20-122-437-8188, Email: asem1967@yahoo.com
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.
Clinical Details
Official title: Randomized Controlled Study of Off-Label Use of Ribavirin in Management of Mucocutaneous Extrahepatic Manifestations of HCV Infection
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Percentage of participants with improved skin manifestations of HCV infection after taking Ribavirin compared with topical steroids.
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
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Asem A Elfert, MD, Phone: +20-122-437-8188, Email: asem1967@yahoo.com
Tanta University Hospital, Tanta, Gharbia 31111, Egypt; Recruiting Asem A Elfert, MD, Phone: +20-122-437-8188, Email: asem1967@yahoo.com Asem A Elfert, MD, Principal Investigator Fat-heya E Assel, MD, Sub-Investigator Mohamed Y Rabei, Sub-Investigator Islam S Ismail, Sub-Investigator
Additional Information
Starting date: June 2014
Last updated: October 6, 2014
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