Off-Label Use of Ribavirin in Management of Mucocutaneous Extrahepatic Manifestations of HCV Infection
Randomized Controlled Study of Off-Label Use of Ribavirin in Management of Mucocutaneous Extrahepatic Manifestations of HCV Infection
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 26, 2014
CompletedFirst Posted
Study publicly available on registry
October 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedOctober 10, 2014
October 1, 2014
5 months
September 26, 2014
October 6, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of participants with improved skin manifestations of HCV infection after taking Ribavirin compared with topical steroids.
6 months
Study Arms (2)
Ribavirin and Betamethasone
EXPERIMENTALA 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 alone
EXPERIMENTALTopical steroids alone will be used; Betamethasone.
Interventions
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
Eligibility Criteria
You may qualify if:
- Patients with evidence of HCV infection and mucocutaneous complaint and contraindicated to have standard antiviral therapy.
You may not qualify if:
- Hypersensitivity to Ribavirin
- Pregnant \& Lactating women
- Male partners of pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanta Universitylead
Study Sites (1)
Tanta University Hospital
Tanta, Gharbia Governorate, 31111, Egypt
Related Publications (12)
Alter MJ. Epidemiology of hepatitis C virus infection. World J Gastroenterol. 2007 May 7;13(17):2436-41. doi: 10.3748/wjg.v13.i17.2436.
PMID: 17552026RESULTAlavian SM. Hepatitis C infection in Iran; A review article. Iran J Clin Infect Dis. 2009;4(1):47-59
RESULTKaldor JM, Dore GJ, Correll PK. Public health challenges in hepatitis C virus infection. J Gastroenterol Hepatol. 2000 May;15 Suppl:E83-90. doi: 10.1046/j.1440-1746.2000.02134.x.
PMID: 10921388RESULTPatrick 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.
PMID: 11059125RESULTPrati 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.
PMID: 11059069RESULTAlavian 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.
PMID: 20491973RESULTEl-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.
RESULTShepard CW, Finelli L, Alter MJ. Global epidemiology of hepatitis C virus infection. Lancet Infect Dis. 2005 Sep;5(9):558-67. doi: 10.1016/S1473-3099(05)70216-4.
PMID: 16122679RESULTClifford 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.
PMID: 7533120RESULTGalossi A, Guarisco R, Bellis L, Puoti C. Extrahepatic manifestations of chronic HCV infection. J Gastrointestin Liver Dis. 2007 Mar;16(1):65-73.
PMID: 17410291RESULTPoljacki 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. Croatian.
PMID: 10965678RESULTCordel N, Chosidow O, Frances C. Cutaneous disorders associated with hepatitis C virus infection. Ann Med Interne (Paris). 2000 Feb;151(1):46-52.
PMID: 10761562RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
September 26, 2014
First Posted
October 10, 2014
Study Start
June 1, 2014
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
October 10, 2014
Record last verified: 2014-10