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

NCT04128358 | Unknown DMC

• 1 other identifier: Skhaled21
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Idiopathic Thrombocytopenic Purpura

Outcome Measures

Primary Outcomes (4)

• Incidence

  Number of ITP patients on Triple therapy became infected with blood born viral hepatitis.

  6-months

• Platelet count

  Number of ITP patients on Triple therapy infected with HCV or HBV and their platelet count

  6-months

• 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

• Risk factors

  Number of ITP patients who became infected with HCV or HBV after exposure to a risk factor

  6-months

Study Arms (3)

Group on high dose dexamethasone, cyclosporin and rituximab

EXPERIMENTAL

Egyptian patients with idiopathic thrombocytopenic purpura on high dose dexamethasone together with cyclosporine and rituximab.

Diagnostic Test: Serological assay for blood born viral hepatitis; Diagnostic Test: Quantitative microbiological test for HCV

Group on steroids only

ACTIVE COMPARATOR

Egyptian patients with idiopathic thrombocytopenic purpura on parenteral or oral steroids.

Diagnostic Test: Serological assay for blood born viral hepatitis; Diagnostic Test: Quantitative microbiological test for HCV

Placebo group

PLACEBO COMPARATOR

Egyptian normal healthy volunteers who share on the President Initiative (100 Million Health).

Diagnostic Test: Serological assay for blood born viral hepatitis; Diagnostic Test: Quantitative microbiological test for HCV

Interventions

Serological assay for blood born viral hepatitis DIAGNOSTIC_TEST

Qualitative PCR for patients with hepatitis C antibody positive

Also known as: Qualitative Polymerase chain reaction (PCR)

Group on high dose dexamethasone, cyclosporin and rituximab; Group on steroids only; Placebo group

Quantitative microbiological test for HCV DIAGNOSTIC_TEST

Quantitative PCR in those with proven HCV infection

Group on high dose dexamethasone, cyclosporin and rituximab; Group on steroids only; Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related Publications (10)

• 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, Kuhne 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.

  PMID: 19005182 BACKGROUND

• 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. doi: 10.1532/ijh97.04176.

  PMID: 15765777 BACKGROUND

• Patel VL, Mahevas 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.

  PMID: 22566601 BACKGROUND

• 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, Ronnov-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.

  PMID: 23293082 BACKGROUND

• 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.

  PMID: 28404132 BACKGROUND

• 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.

  PMID: 29374178 BACKGROUND

• Wedemeyer H, Duberg AS, Buti M, Rosenberg WM, Frankova S, Esmat G, Ormeci N, Van Vlierberghe H, Gschwantler M, Akarca U, Aleman S, Balik I, Berg T, Bihl F, Bilodeau M, Blasco AJ, Brandao 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, Ergor G, Estes C, Falconer K, Felix J, Ferraz ML, Ferreira PR, Garcia-Samaniego J, Gerstoft J, Giria JA, Goncales FL Jr, Guimaraes Pessoa M, Hezode C, Hindman SJ, Hofer H, Husa P, Idilman R, Kaberg M, Kaita KD, Kautz A, Kaymakoglu S, Krajden M, Krarup H, Laleman W, Lavanchy D, Lazaro P, Marinho RT, Marotta P, Mauss S, Mendes Correa MC, Moreno C, Mullhaupt B, Myers RP, Nemecek V, Ovrehus 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, Starkel 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.

  PMID: 24713006 BACKGROUND

• 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. doi: 10.1086/423384. Epub 2004 Aug 27.

  PMID: 15472809 BACKGROUND

• 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.

  PMID: 19843383 BACKGROUND

• 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. doi: 10.1002/ajh.21022.

  PMID: 17712791 BACKGROUND

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Mohamed El yamany, Prof.

  Assiut University

  STUDY DIRECTOR

• Shymaa M Nageeb, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

• Eman NaserEldin, Prof

  Assiut University

  PRINCIPAL INVESTIGATOR

• Ahmed Khair, Ass. Prof.

  faculty of medicine

  STUDY DIRECTOR

Central Study Contacts

Safaa A Khaled, Ass. Prof.

CONTACT

01064170058; safaakhaled2003@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: This is a randomized clinical trial aimed to assess the effect of strong immunosuppression in patients with ITP on Triple therapy on acquiring viral hepatitis infection C or B.

Study Record Dates

• First Submitted: October 13, 2019
• First Posted: October 16, 2019
• Study Start: November 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: June 1, 2021
• Last Updated: October 24, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)