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

Primary Purpose

Hepatitis C, Lichen Planus, Vasculitis

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ribavirin
Betamethasone
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tanta University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ribavirin and Betamethasone

Betamethasone alone

Arm Description

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

Topical steroids alone will be used; Betamethasone.

Outcomes

Primary Outcome Measures

Percentage of participants with improved skin manifestations of HCV infection after taking Ribavirin compared with topical steroids.

Secondary Outcome Measures

Full Information

First Posted
September 26, 2014
Last Updated
October 6, 2014
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT02261662
Brief Title
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

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
November 2014 (Anticipated)
Study Completion Date
November 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Lichen Planus, Vasculitis, Autoimmune Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ribavirin and Betamethasone
Arm Type
Experimental
Arm Description
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
Arm Title
Betamethasone alone
Arm Type
Experimental
Arm Description
Topical steroids alone will be used; Betamethasone.
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
Copegus
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Betamethasone
Other Intervention Name(s)
Corticosteroid
Intervention Description
Topical Steroids alone will be used; Betamethasone
Primary Outcome Measure Information:
Title
Percentage of participants with improved skin manifestations of HCV infection after taking Ribavirin compared with topical steroids.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Asem A Elfert, MD
Phone
+20-122-437-8188
Email
asem1967@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asem A Elfert, MD
Organizational Affiliation
Tanta Faculty of Medicine, Professor
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fat-heya E Assel, MD
Organizational Affiliation
Tanta Faculty of Medicine, Professor
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohamed Y Rabei
Organizational Affiliation
Dr.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Islam S Ismail
Organizational Affiliation
Dr.
Official's Role
Study Director
Facility Information:
Facility Name
Tanta University Hospital
City
Tanta
State/Province
Gharbia
ZIP/Postal Code
31111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asem A Elfert, MD
Phone
+20-122-437-8188
Email
asem1967@yahoo.com
First Name & Middle Initial & Last Name & Degree
Asem A Elfert, MD
First Name & Middle Initial & Last Name & Degree
Fat-heya E Assel, MD
First Name & Middle Initial & Last Name & Degree
Mohamed Y Rabei
First Name & Middle Initial & Last Name & Degree
Islam S Ismail

12. IPD Sharing Statement

Citations:
PubMed Identifier
17552026
Citation
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PubMed Identifier
10921388
Citation
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PubMed Identifier
11059125
Citation
Patrick DM, Buxton JA, Bigham M, Mathias RG. Public health and hepatitis C. Can J Public Health. 2000 Jul-Aug;91 Suppl 1:S18-21, S19-23. English, French.
Results Reference
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PubMed Identifier
11059069
Citation
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PubMed Identifier
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Citation
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Citation
El-Zanaty F, Way A. Egypt Demographic and Health Survey 2008. Egyptian: Ministry of Health. Cairo: El-Zanaty and Associates and Macro International; 2009. p. 431.
Results Reference
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PubMed Identifier
16122679
Citation
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PubMed Identifier
7533120
Citation
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Citation
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Citation
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Citation
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Results Reference
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Off-Label Use of Ribavirin in Management of Mucocutaneous Extrahepatic Manifestations of HCV Infection

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