Triple Therapy in Patients With Idiopathic Thrombocytopenic Purpura : What is Behind?

Idiopathic Thrombocytopenic Purpura Clinical Trial

Official title:

Triple Therapy in Patients With Idiopathic Thrombocytopenic Purpura : What is Behind?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04128358
• Other study ID #: Skhaled21
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2019
• Est. completion date: June 2021

Study information

• Verified date: October 2019
• Source: Assiut University
• Contact: Safaa A Khaled, Ass. Prof.
• Phone: 01064170058
• Email: safaakhaled2003[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Idiopathic thrombocytopenic purpura (ITP) is a benign hematological disorder characterized by isolated thrombocytopenia. Development of antiplatelet autoantibodies is the main pathogenetic mechanism in patients with ITP. However the exact pathogenesis of ITP is complex in which megakaryocyte immune injury and T-cell mediated platelet destruction play significant role. Accordingly treatment of ITP relies mainly on immunosuppression. Recently triple regimen of high dose dexamethasone together with cyclosporine and rituximab was found to induce prolonged remission in patients with ITP compared with single agent immunosuppression. On the other hand this regimen suppresses all immune cells thus predisposing patient to serious infections, which is the main cause of morbidity in ITP furthermore infection enhances autoimmunity.

This study will focus on viral hepatitis C and B infection in Egyptian patients with idiopathic thrombocytopenic purpura on Triple therapy and aims to:

• Assess and improve preventive measures of blood born hepatitis infection in the hematology ward in Egypt.

• Investigate influence of immunosuppression on infection with blood born hepatitis on Egyptian patients with ITP on Triple therapy.

• Study the impact of blood born hepatitis infection on clinical outcome on those patients.

• Identify risk factors and routes of transmission of blood born viral hepatitis in the hematology ward in Egypt

Description:

Blood born viral hepatitis is a type of viral hepatitis that is usually transmitted with transfusion of blood and blood products. Accordingly patients with hematological disorders are at higher risk for infection with blood born hepatitis as blood transfusion besides regular sampling are integral parts in management of hematological patients. This was the case in patients with ITP, however not all patients with ITP in need for regular platelet transfusion. The mainstay of treatment of ITP is immunosuppression, that was mainly dependent on parenteral or oral steroids for long time. Triple therapy was recently introduced for treatment of patients with ITP it induces strong immunosuppression that could make patients vulnerable to infections.

Several studies accused immunosuppression in patients with hematological malignancies under chemotherapy to be a risk factor for infection with blood born hepatitis, as such triple therapy could predispose patients with ITP to blood born viral hepatitis infection.

On the other hand infection with blood born hepatitis in patients with ITP on Triple therapy could affect patient outcome and response to treatment. This is because thrombocytopenia is a common extra hepatic manifestation of hepatitis C viral infection on its chronic form.

Egypt is a country with high prevalence of blood born viral hepatitis viral hepatitis C. Recently, the president of Egypt elaborated an initiative (100 million Health) that was managed with the Ministry of Health in all over the country. This initiative aimed to eliminate blood born hepatitis particularly C from the Country.

This work will be conducted in Egypt and focused on ITP patients on Triple therapy to assess their vulnerability for infection with blood born hepatitis as they are a particular sector of the Egyptian population at higher risk for infection.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: June 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Normal healthy Egyptians on the age range from 18-85.

• Egyptian patients with ITP in age range from 18- 65 on high dose dexamethasone together with cyclosporin and rituximab .

• Egyptian patients with ITP in age range from 18- 65 on parenteral or oral steriods.

Exclusion Criteria:

• Age less than 18 years old.

• Pregnancy

• Thrombocytopenia other than ITP.

• Patients with ITP but on other modalities of treatment.

• Patients with blood born viral hepatitis infection before treatment with high dose dexamethasone together with cyclosporin and rituximab

Related Conditions & MeSH terms

• Idiopathic Thrombocytopenic Purpura
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic

Intervention

Diagnostic Test:
• Serological assay for blood born viral hepatitis
Qualitative PCR for patients with hepatitis C antibody positive
• Quantitative microbiological test for HCV
Quantitative PCR in those with proven HCV infection

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (10)

Aref S, Sleem T, El Menshawy N, Ebrahiem L, Abdella D, Fouda M, Samara NA, Menessy A, Abdel-Ghaffar H, Bassam A, Abdel Wahaab M. Antiplatelet antibodies contribute to thrombocytopenia associated with chronic hepatitis C virus infection. Hematology. 2009 Oct;14(5):277-81. doi: 10.1179/102453309X439818. — View Citation

Ennishi D, Terui Y, Yokoyama M, Mishima Y, Takahashi S, Takeuchi K, Okamoto H, Tanimoto M, Hatake K. Monitoring serum hepatitis C virus (HCV) RNA in patients with HCV-infected CD20-positive B-cell lymphoma undergoing rituximab combination chemotherapy. Am J Hematol. 2008 Jan;83(1):59-62. — View Citation

Gudbrandsdottir S, Birgens HS, Frederiksen H, Jensen BA, Jensen MK, Kjeldsen L, Klausen TW, Larsen H, Mourits-Andersen HT, Nielsen CH, Nielsen OJ, Plesner T, Pulczynski S, Rasmussen IH, Rønnov-Jessen D, Hasselbalch HC. Rituximab and dexamethasone vs dexamethasone monotherapy in newly diagnosed patients with primary immune thrombocytopenia. Blood. 2013 Mar 14;121(11):1976-81. doi: 10.1182/blood-2012-09-455691. Epub 2013 Jan 4. — View Citation

Kouyoumjian SP, Chemaitelly H, Abu-Raddad LJ. Characterizing hepatitis C virus epidemiology in Egypt: systematic reviews, meta-analyses, and meta-regressions. Sci Rep. 2018 Jan 26;8(1):1661. doi: 10.1038/s41598-017-17936-4. Review. — View Citation

Kuwana M, Ikeda Y. The role of autoreactive T-cells in the pathogenesis of idiopathic thrombocytopenic purpura. Int J Hematol. 2005 Feb;81(2):106-12. Review. — View Citation

Patel VL, Mahévas M, Lee SY, Stasi R, Cunningham-Rundles S, Godeau B, Kanter J, Neufeld E, Taube T, Ramenghi U, Shenoy S, Ward MJ, Mihatov N, Patel VL, Bierling P, Lesser M, Cooper N, Bussel JB. Outcomes 5 years after response to rituximab therapy in children and adults with immune thrombocytopenia. Blood. 2012 Jun 21;119(25):5989-95. doi: 10.1182/blood-2011-11-393975. Epub 2012 May 7. — View Citation

Polaris Observatory HCV Collaborators. Global prevalence and genotype distribution of hepatitis C virus infection in 2015: a modelling study. Lancet Gastroenterol Hepatol. 2017 Mar;2(3):161-176. doi: 10.1016/S2468-1253(16)30181-9. Epub 2016 Dec 16. Review. — View Citation

Rodeghiero F, Stasi R, Gernsheimer T, Michel M, Provan D, Arnold DM, Bussel JB, Cines DB, Chong BH, Cooper N, Godeau B, Lechner K, Mazzucconi MG, McMillan R, Sanz MA, Imbach P, Blanchette V, Kühne T, Ruggeri M, George JN. Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group. Blood. 2009 Mar 12;113(11):2386-93. doi: 10.1182/blood-2008-07-162503. Epub 2008 Nov 12. — View Citation

Wang CS, Yao WJ, Wang ST, Chang TT, Chou P. Strong association of hepatitis C virus (HCV) infection and thrombocytopenia: implications from a survey of a community with hyperendemic HCV infection. Clin Infect Dis. 2004 Sep 15;39(6):790-6. Epub 2004 Aug 27. — View Citation

Wedemeyer H, Duberg AS, Buti M, Rosenberg WM, Frankova S, Esmat G, Örmeci N, Van Vlierberghe H, Gschwantler M, Akarca U, Aleman S, Balik I, Berg T, Bihl F, Bilodeau M, Blasco AJ, Brandão Mello CE, Bruggmann P, Calinas F, Calleja JL, Cheinquer H, Christensen PB, Clausen M, Coelho HS, Cornberg M, Cramp ME, Dore GJ, Doss W, El-Sayed MH, Ergör G, Estes C, Falconer K, Félix J, Ferraz ML, Ferreira PR, García-Samaniego J, Gerstoft J, Giria JA, Gonçales FL Jr, Guimarães Pessôa M, Hézode C, Hindman SJ, Hofer H, Husa P, Idilman R, Kåberg M, Kaita KD, Kautz A, Kaymakoglu S, Krajden M, Krarup H, Laleman W, Lavanchy D, Lázaro P, Marinho RT, Marotta P, Mauss S, Mendes Correa MC, Moreno C, Müllhaupt B, Myers RP, Nemecek V, Øvrehus AL, Parkes J, Peltekian KM, Ramji A, Razavi H, Reis N, Roberts SK, Roudot-Thoraval F, Ryder SD, Sarmento-Castro R, Sarrazin C, Semela D, Sherman M, Shiha GE, Sperl J, Stärkel P, Stauber RE, Thompson AJ, Urbanek P, Van Damme P, van Thiel I, Vandijck D, Vogel W, Waked I, Weis N, Wiegand J, Yosry A, Zekry A, Negro F, Sievert W, Gower E. Strategies to manage hepatitis C virus (HCV) disease burden. J Viral Hepat. 2014 May;21 Suppl 1:60-89. doi: 10.1111/jvh.12249. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence	Number of ITP patients on Triple therapy became infected with blood born viral hepatitis.	6-months
Primary	Platelet count	Number of ITP patients on Triple therapy infected with HCV or HBV and their platelet count	6-months
Primary	Primary prevention	Number of medical and paramedical staff who follow preventive measures for HCV and HBV in the hematology ward before and after an educational program	One month
Primary	Risk factors	Number of ITP patients who became infected with HCV or HBV after exposure to a risk factor	6-months