<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02261662</url>
  </required_header>
  <id_info>
    <org_study_id>Ribavirin HCV mucocutaneous</org_study_id>
    <nct_id>NCT02261662</nct_id>
  </id_info>
  <brief_title>Off-Label Use of Ribavirin in Management of Mucocutaneous Extrahepatic Manifestations of HCV Infection</brief_title>
  <official_title>Randomized Controlled Study of Off-Label Use of Ribavirin in Management of Mucocutaneous Extrahepatic Manifestations of HCV Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tanta University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tanta University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will be conducted on 30 patients with mucocutaneous complaints and documented HCV&#xD;
      infection. The study will be done at Tropical medicine department , Tanta university. It will&#xD;
      be conducted between June2014 and November 2014.&#xD;
&#xD;
      The aim of the study is to assess efficacy of Ribavirin in the management of mucocutaneous&#xD;
      extrahepatic manifestations of HCV infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hepatitis C virus is a common cause of chronic liver disease worldwide and represent public&#xD;
      health problem. The Egyptian Demographic Health Survey (EDHS), a cross sectional survey&#xD;
      including hepatitis C virus (HCV) biomarkers, was conducted in 2008 on a large nationally&#xD;
      representative sample. It estimated HCV prevalence among the 15-59 years age group to be&#xD;
      14.7% . Accordingly, Egypt has the highest HCV prevalence in the world.&#xD;
&#xD;
      Although HCV is a hepatotropic virus, in some patients the primary manifestations of&#xD;
      infection occur outside the liver. There is a growing body of evidence to support the idea&#xD;
      that HCV can replicate efficiently in extrahepatic tissues including the Peripheral blood&#xD;
      mononuclear cells (PBMC). Autoimmune manifestations are common in patients chronically&#xD;
      infected by HCV . These manifestations can be dominant, whereas the hepatic disease can be&#xD;
      quiescent or mild. More recently, there has been growing interest in the relationship between&#xD;
      HCV and Sjogren's syndrome (SS), rheumatoid arthritis (RA), and systemic lupus erythematosus&#xD;
      (SLE).&#xD;
&#xD;
      Of those , this article is interested in cutaneous and mucous membrane manifestations where&#xD;
      many reports have shown that cutaneous manifestations are often the first signs of chronic&#xD;
      HCV infection and these are indicated in 20-40% of the patients presenting to the dermatology&#xD;
      clinics, therefore dermatologists must be aware of skin disorders associated with viral&#xD;
      infection. The most commonly encountered dermatological manifestations of HCV infection&#xD;
      includes mixed cryoglobulinemia (MC), porphyria cutanea tarda (PCT), cutaneous and/or oral&#xD;
      lichen planus (LP), urticaria, pruritus, thrombocytopenic purpura and cutaneous vasculitis.&#xD;
      Although majority of skin manifestations of chronic HCV infection represent the clinical&#xD;
      impression of autoimmune phenomena, however, precise pathogenesis of these extra-hepatic&#xD;
      complications is not well understood.&#xD;
&#xD;
      The aim of the study is to assess efficacy of Ribavirin in the management of mucocutaneous&#xD;
      extrahepatic manifestations of HCV infection&#xD;
&#xD;
      This study will be conducted on 30 patients with mucocutaneous complaints and documented HCV&#xD;
      infection. The study will be done at Tropical medicine department , Tanta university. It will&#xD;
      be conducted between June2014 and November 2014.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">November 2014</completion_date>
  <primary_completion_date type="Anticipated">November 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of participants with improved skin manifestations of HCV infection after taking Ribavirin compared with topical steroids.</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Hepatitis C</condition>
  <condition>Lichen Planus</condition>
  <condition>Vasculitis</condition>
  <condition>Autoimmune Diseases</condition>
  <arm_group>
    <arm_group_label>Ribavirin and Betamethasone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A nucleoside antimetabolite antiviral agent that blocks nucleic acid synthesis and is used against both RNA and DNA viruses.&#xD;
It will be used along with Topical steroids; Betamethasone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Betamethasone alone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Topical steroids alone will be used; Betamethasone.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ribavirin</intervention_name>
    <description>A nucleoside antimetabolite antiviral agent that blocks nucleic acid synthesis and is used against both RNA and DNA viruses.&#xD;
It will be used along with Topical steroids; Betamethasone</description>
    <arm_group_label>Ribavirin and Betamethasone</arm_group_label>
    <other_name>Copegus</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Betamethasone</intervention_name>
    <description>Topical Steroids alone will be used; Betamethasone</description>
    <arm_group_label>Betamethasone alone</arm_group_label>
    <arm_group_label>Ribavirin and Betamethasone</arm_group_label>
    <other_name>Corticosteroid</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with evidence of HCV infection and mucocutaneous complaint and&#xD;
             contraindicated to have standard antiviral therapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hypersensitivity to Ribavirin&#xD;
&#xD;
          -  Pregnant &amp; Lactating women&#xD;
&#xD;
          -  Male partners of pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Asem A Elfert, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tanta Faculty of Medicine, Professor</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fat-heya E Assel, MD</last_name>
    <role>Study Director</role>
    <affiliation>Tanta Faculty of Medicine, Professor</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohamed Y Rabei</last_name>
    <role>Study Director</role>
    <affiliation>Dr.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Islam S Ismail</last_name>
    <role>Study Director</role>
    <affiliation>Dr.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Asem A Elfert, MD</last_name>
    <phone>+20-122-437-8188</phone>
    <email>asem1967@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Tanta University Hospital</name>
      <address>
        <city>Tanta</city>
        <state>Gharbia</state>
        <zip>31111</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Asem A Elfert, MD</last_name>
      <phone>+20-122-437-8188</phone>
      <email>asem1967@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Asem A Elfert, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Fat-heya E Assel, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mohamed Y Rabei</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Islam S Ismail</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <results_reference>
    <citation>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.</citation>
    <PMID>17552026</PMID>
  </results_reference>
  <results_reference>
    <citation>Alavian SM. Hepatitis C infection in Iran; A review article. Iran J Clin Infect Dis. 2009;4(1):47-59</citation>
  </results_reference>
  <results_reference>
    <citation>Kaldor 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.</citation>
    <PMID>10921388</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>11059125</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>11059069</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>20491973</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
  </results_reference>
  <results_reference>
    <citation>Shepard 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.</citation>
    <PMID>16122679</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>7533120</PMID>
  </results_reference>
  <results_reference>
    <citation>Galossi A, Guarisco R, Bellis L, Puoti C. Extrahepatic manifestations of chronic HCV infection. J Gastrointestin Liver Dis. 2007 Mar;16(1):65-73.</citation>
    <PMID>17410291</PMID>
  </results_reference>
  <results_reference>
    <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. Croatian.</citation>
    <PMID>10965678</PMID>
  </results_reference>
  <results_reference>
    <citation>Cordel N, Chosidow O, Frances C. Cutaneous disorders associated with hepatitis C virus infection. Ann Med Interne (Paris). 2000 Feb;151(1):46-52.</citation>
    <PMID>10761562</PMID>
  </results_reference>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>October 6, 2014</last_update_submitted>
  <last_update_submitted_qc>October 6, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tanta University</investigator_affiliation>
    <investigator_full_name>Ibrahim Shebl</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Vasculitis</mesh_term>
    <mesh_term>Lichen Planus</mesh_term>
    <mesh_term>Autoimmune Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ribavirin</mesh_term>
    <mesh_term>Betamethasone</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02261662
org study id: Ribavirin HCV mucocutaneous
nct id: NCT02261662
lead sponsor: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of participants with improved skin manifestations of HCV infection after taking Ribavirin compared with topical steroids.
time frame: 6 months
arm group label: Ribavirin and Betamethasone
arm group type: Experimental
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 group label: Betamethasone alone
arm group type: Experimental
description: Topical steroids alone will be used; Betamethasone.
intervention type: Drug
intervention name: Ribavirin
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 group label: Ribavirin and Betamethasone
other name: Copegus
intervention type: Drug
intervention name: Betamethasone
description: Topical Steroids alone will be used; Betamethasone
arm group label: Betamethasone alone
arm group label: Ribavirin and Betamethasone
other name: Corticosteroid
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Asem A Elfert, MD
role: Principal Investigator
affiliation: Tanta Faculty of Medicine, Professor
last name: Fat-heya E Assel, MD
role: Study Director
affiliation: Tanta Faculty of Medicine, Professor
last name: Mohamed Y Rabei
role: Study Director
affiliation: Dr.
last name: Islam S Ismail
role: Study Director
affiliation: Dr.
last name: Asem A Elfert, MD
phone: +20-122-437-8188
email: asem1967@yahoo.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Egypt
citation: 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: 17552026
citation: Alavian SM. Hepatitis C infection in Iran; A review article. Iran J Clin Infect Dis. 2009;4(1):47-59
citation: Kaldor 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: 10921388
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.
PMID: 11059125
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.
PMID: 11059069
citation: 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.
PMID: 20491973
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.
citation: Shepard 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: 16122679
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.
PMID: 7533120
citation: Galossi A, Guarisco R, Bellis L, Puoti C. Extrahepatic manifestations of chronic HCV infection. J Gastrointestin Liver Dis. 2007 Mar;16(1):65-73.
PMID: 17410291
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. Croatian.
PMID: 10965678
citation: Cordel N, Chosidow O, Frances C. Cutaneous disorders associated with hepatitis C virus infection. Ann Med Interne (Paris). 2000 Feb;151(1):46-52.
PMID: 10761562
responsible party type: Principal Investigator
investigator affiliation: Tanta University
investigator full name: Ibrahim Shebl
investigator title: Dr.
mesh term: Hepatitis C
mesh term: Vasculitis
mesh term: Lichen Planus
mesh term: Autoimmune Diseases
mesh term: Ribavirin
mesh term: Betamethasone