Off-Label Use of Ribavirin in Management of Mucocutaneous Extrahepatic Manifestations of HCV Infection

October 6, 2014 updated by: Ibrahim Shebl, Tanta University

Randomized Controlled Study of Off-Label Use of Ribavirin in 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.

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Gharbia
      • Tanta, Gharbia, Egypt, 31111
        • Recruiting
        • Tanta University Hospital
        • Contact:
        • Principal Investigator:
          • Asem A Elfert, MD
        • Sub-Investigator:
          • Fat-heya E Assel, MD
        • Sub-Investigator:
          • Islam S Ismail
        • Sub-Investigator:
          • Mohamed Y Rabei

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ribavirin and Betamethasone

A nucleoside antimetabolite antiviral agent that blocks nucleic acid synthesis and is used against both RNA and DNA viruses.

It will be used along with Topical steroids; Betamethasone
Drug: Ribavirin

A nucleoside antimetabolite antiviral agent that blocks nucleic acid synthesis and is used against both RNA and DNA viruses.

It will be used along with Topical steroids; Betamethasone

Other Names:
  • Copegus
Drug: Betamethasone
Topical Steroids alone will be used; Betamethasone
Other Names:
  • Corticosteroid
Experimental: Betamethasone alone
Topical steroids alone will be used; Betamethasone.
Drug: Betamethasone
Topical Steroids alone will be used; Betamethasone
Other Names:
  • Corticosteroid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants with improved skin manifestations of HCV infection after taking Ribavirin compared with topical steroids.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Principal Investigator: Asem A Elfert, MD, Tanta Faculty of Medicine, Professor
  • Study Director: Islam S Ismail, Dr.
  • Study Director: Fat-heya E Assel, MD, Tanta Faculty of Medicine, Professor
  • Study Director: Mohamed Y Rabei, Dr.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

November 1, 2014

Study Completion (Anticipated)

November 1, 2014

Study Registration Dates

First Submitted

September 26, 2014

First Submitted That Met QC Criteria

October 6, 2014

First Posted (Estimate)

October 10, 2014

Study Record Updates

Last Update Posted (Estimate)

October 10, 2014

Last Update Submitted That Met QC Criteria

October 6, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ribavirin HCV mucocutaneous

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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