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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02261662
• Other study ID #: Ribavirin HCV mucocutaneous
• Status: Recruiting
• Phase: N/A
• First received: September 26, 2014
• Last updated: October 6, 2014
• Start date: June 2014
• Est. completion date: November 2014

Study information

• Verified date: October 2014
• Source: Tanta University
• Contact: Asem A Elfert, MD
• Phone: +20-122-437-8188
• Email: asem1967[@]yahoo.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autoimmune Diseases
• Hepatitis C
• Lichen Planus
• Vasculitis

Intervention

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
• Betamethasone
Topical Steroids alone will be used; Betamethasone

Locations

Country	Name	City	State
Egypt	Tanta University Hospital	Tanta	Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

References & Publications (12)

Alavian SM, Kabir A, Ahmadi AB, Lankarani KB, Shahbabaie MA, Ahmadzad-Asl M. Hepatitis C infection in hemodialysis patients in Iran: a systematic review. Hemodial Int. 2010 Jul;14(3):253-62. doi: 10.1111/j.1542-4758.2010.00437.x. Epub 2010 May 17. Review. — View Citation

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

Alter MJ. Epidemiology of hepatitis C virus infection. World J Gastroenterol. 2007 May 7;13(17):2436-41. Review. — View Citation

Clifford BD, Donahue D, Smith L, Cable E, Luttig B, Manns M, Bonkovsky HL. High prevalence of serological markers of autoimmunity in patients with chronic hepatitis C. Hepatology. 1995 Mar;21(3):613-9. — View Citation

Cordel N, Chosidow O, Francès C. Cutaneous disorders associated with hepatitis C virus infection. Ann Med Interne (Paris). 2000 Feb;151(1):46-52. Review. — View 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.

Galossi A, Guarisco R, Bellis L, Puoti C. Extrahepatic manifestations of chronic HCV infection. J Gastrointestin Liver Dis. 2007 Mar;16(1):65-73. Review. — View Citation

Kaldor JM, Dore GJ, Correll PK. Public health challenges in hepatitis C virus infection. J Gastroenterol Hepatol. 2000 May;15 Suppl:E83-90. — View 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. Review. English, French. — View Citation

Poljacki M, Gajinov Z, Ivkov M, Matic M, Golusin Z. [Skin diseases and hepatitis virus C infection]. Med Pregl. 2000 Mar-Apr;53(3-4):141-5. Review. Croatian. — View Citation

Prati F, Lodi V, D'Elia V, Truffelli D, Lalic H, Raffi GB. Screening of health care workers for hepatitis B virus and hepatitis C virus: criteria for fitness for work. Arh Hig Rada Toksikol. 2000 Mar;51(1):19-26. — View Citation

Shepard CW, Finelli L, Alter MJ. Global epidemiology of hepatitis C virus infection. Lancet Infect Dis. 2005 Sep;5(9):558-67. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with improved skin manifestations of HCV infection after taking Ribavirin compared with topical steroids.		6 months	Yes