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Trial record 75 of 272 for:    Betamethasone

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02261662
Recruitment Status : Unknown
Verified October 2014 by Ibrahim Shebl, Tanta University.
Recruitment status was:  Recruiting
First Posted : October 10, 2014
Last Update Posted : October 10, 2014
Sponsor:
Information provided by (Responsible Party):
Ibrahim Shebl, Tanta University

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.


Condition or disease Intervention/treatment Phase
Hepatitis C Lichen Planus Vasculitis Autoimmune Diseases Drug: Ribavirin Drug: Betamethasone Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Study of Off-Label Use of Ribavirin in Management of Mucocutaneous Extrahepatic Manifestations of HCV Infection
Study Start Date : June 2014
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : November 2014


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 Name: Copegus

Drug: Betamethasone
Topical Steroids alone will be used; Betamethasone
Other Name: Corticosteroid

Experimental: Betamethasone alone
Topical steroids alone will be used; Betamethasone.
Drug: Betamethasone
Topical Steroids alone will be used; Betamethasone
Other Name: Corticosteroid




Primary Outcome Measures :
  1. Percentage of participants with improved skin manifestations of HCV infection after taking Ribavirin compared with topical steroids. [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02261662


Contacts
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Contact: Asem A Elfert, MD +20-122-437-8188 asem1967@yahoo.com

Locations
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Egypt
Tanta University Hospital Recruiting
Tanta, Gharbia, Egypt, 31111
Contact: Asem A Elfert, MD    +20-122-437-8188    asem1967@yahoo.com   
Principal Investigator: Asem A Elfert, MD         
Sub-Investigator: Fat-heya E Assel, MD         
Sub-Investigator: Mohamed Y Rabei         
Sub-Investigator: Islam S Ismail         
Sponsors and Collaborators
Tanta University
Investigators
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Principal Investigator: Asem A Elfert, MD Tanta Faculty of Medicine, Professor
Study Director: Fat-heya E Assel, MD Tanta Faculty of Medicine, Professor
Study Director: Mohamed Y Rabei Dr.
Study Director: Islam S Ismail Dr.

Publications of Results:
Alavian SM. Hepatitis C infection in Iran; A review article. Iran J Clin Infect Dis. 2009;4(1):47-59
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.

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Responsible Party: Ibrahim Shebl, Dr., Tanta University
ClinicalTrials.gov Identifier: NCT02261662     History of Changes
Other Study ID Numbers: Ribavirin HCV mucocutaneous
First Posted: October 10, 2014    Key Record Dates
Last Update Posted: October 10, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Betamethasone sodium phosphate
Hepatitis C
Vasculitis
Lichen Planus
Autoimmune Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Immune System Diseases
Vascular Diseases
Cardiovascular Diseases
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones