Viral Hepatitis B and C Infection in Patients With Idiopathic Thrombocytopenic Purpura Treated With Triple Therapy

NCT04113915 | Unknown

• 1 other identifier: Viral hepatitis in ITP
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

Aim of the work To estimate frequency of viral HB \& C infection in ITP patients who received triple therapy in comparison with another group treated with steroids only. To explore risk factors and routes of transmission of viral HB \& C infection in ITP patients who received triple therapy and the another group treated with steroids . \- To assess preventive measures of viral HB\& C infection in the hematology ward To investigate the influence of viral HB \& C infection on clinical picture, response to treatment and side effects in ITP patients who received triple therapy or steroids.

Conditions

ITP - Immune Thrombocytopenic Purpura; Viral Hepatitis

Outcome Measures

Primary Outcomes (1)

• To estimate frequency of viral HB & C infection in ITP patients who received triple therapy in comparison with another group treated with steroids and risk factors affecting infection

  1 year

Secondary Outcomes (1)

• 1-To assess preventive measures of viral HB& C infection in the hematology ward 2-to asses effect of viral hepatitis b,c on clinical picture , response to treatment and side effects in ITP patients received triple therapy

  1year

Study Arms (3)

Group 1

Group of ITP patients received triple therapy

Drug: triple therapy

Group 2

Group of ITP patients received steroids

Drug: Steroids

Group 3

Normal control group

Interventions

triple therapy DRUG

Effect of treatment on immunity to obtain infection with hepatitis B\&C

Also known as: High dose dexamethasone together with cyclosporin and rituximab

Group 1

Steroids DRUG

Oral or parenteral steroid therapy for ITP

Also known as: Parenteral decadrone or oral hostacortine

Group 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

On patients with Idiopathic thrombocytopenic Purpura treated with triple therapy or steroids only but more than 18 years and have no other blood diseases or not known to have hepatitis B and C

You may qualify if:

• ITP patients received triple therapy or steroids only more than 18 years old

You may not qualify if:

• All ITP patient less than 18 years old or treated with other regimens except triple therapy or steroids.
• Patients with other bleeding disorders ITP patients with known viral hepatitis B \& C infection before triple therapy

Sponsors & Collaborators

• Safaa AA Khaled: lead

Related Publications (18)

• Choi PY, Roncolato F, Badoux X, Ramanathan S, Ho SJ, Chong BH. A novel triple therapy for ITP using high-dose dexamethasone, low-dose rituximab, and cyclosporine (TT4). Blood. 2015 Jul 23;126(4):500-3. doi: 10.1182/blood-2015-03-631937. Epub 2015 May 13.

  PMID: 25972158 BACKGROUND

• Norgaard M, Jensen AO, Engebjerg MC, Farkas DK, Thomsen RW, Cha S, Zhao S, Sorensen HT. Long-term clinical outcomes of patients with primary chronic immune thrombocytopenia: a Danish population-based cohort study. Blood. 2011 Mar 31;117(13):3514-20. doi: 10.1182/blood-2010-10-312819. Epub 2011 Jan 24.

  PMID: 21263148 BACKGROUND

• Kramar A, Bascoul-Mollevi C. Early stopping rules in clinical trials based on sequential monitoring of serious adverse events. Med Decis Making. 2009 May-Jun;29(3):343-50. doi: 10.1177/0272989X08327332. Epub 2008 Dec 10.

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• Provan D, Stasi R, Newland AC, Blanchette VS, Bolton-Maggs P, Bussel JB, Chong BH, Cines DB, Gernsheimer TB, Godeau B, Grainger J, Greer I, Hunt BJ, Imbach PA, Lyons G, McMillan R, Rodeghiero F, Sanz MA, Tarantino M, Watson S, Young J, Kuter DJ. International consensus report on the investigation and management of primary immune thrombocytopenia. Blood. 2010 Jan 14;115(2):168-86. doi: 10.1182/blood-2009-06-225565. Epub 2009 Oct 21.

  PMID: 19846889 BACKGROUND

• Neunert C, Lim W, Crowther M, Cohen A, Solberg L Jr, Crowther MA; American Society of Hematology. The American Society of Hematology 2011 evidence-based practice guideline for immune thrombocytopenia. Blood. 2011 Apr 21;117(16):4190-207. doi: 10.1182/blood-2010-08-302984. Epub 2011 Feb 16.

  PMID: 21325604 BACKGROUND

• Zaja F, Baccarani M, Mazza P, Bocchia M, Gugliotta L, Zaccaria A, Vianelli N, Defina M, Tieghi A, Amadori S, Campagna S, Ferrara F, Angelucci E, Usala E, Cantoni S, Visani G, Fornaro A, Rizzi R, De Stefano V, Casulli F, Battista ML, Isola M, Soldano F, Gamba E, Fanin R. Dexamethasone plus rituximab yields higher sustained response rates than dexamethasone monotherapy in adults with primary immune thrombocytopenia. Blood. 2010 Apr 8;115(14):2755-62. doi: 10.1182/blood-2009-07-229815. Epub 2010 Feb 3.

  PMID: 20130241 BACKGROUND

• McMillan R, Wang L, Tomer A, Nichol J, Pistillo J. Suppression of in vitro megakaryocyte production by antiplatelet autoantibodies from adult patients with chronic ITP. Blood. 2004 Feb 15;103(4):1364-9. doi: 10.1182/blood-2003-08-2672. Epub 2003 Oct 23.

  PMID: 14576051 BACKGROUND

• Gomez-Almaguer D, Tarin-Arzaga L, Moreno-Jaime B, Jaime-Perez JC, Ceballos-Lopez AA, Ruiz-Arguelles GJ, Ruiz-Delgado GJ, Cantu-Rodriguez OG, Gutierrez-Aguirre CH, Sanchez-Cardenas M. High response rate to low-dose rituximab plus high-dose dexamethasone as frontline therapy in adult patients with primary immune thrombocytopenia. Eur J Haematol. 2013 Jun;90(6):494-500. doi: 10.1111/ejh.12102. Epub 2013 Apr 2.

  PMID: 23470153 BACKGROUND

• Bussel JB, Lee CS, Seery C, Imahiyerobo AA, Thompson MV, Catellier D, Turenne IG, Patel VL, Basciano PA, Elstrom RL, Ghanima W. Rituximab and three dexamethasone cycles provide responses similar to splenectomy in women and those with immune thrombocytopenia of less than two years duration. Haematologica. 2014 Jul;99(7):1264-71. doi: 10.3324/haematol.2013.103291. Epub 2014 Apr 18.

  PMID: 24747949 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

• Apostolidis J, Tsandekidi M, Kousiafes D, Pagoni M, Mitsouli C, Karmiris T, Bakiri M, Karakasis D, Harhalakis N, Nikiforakis E. Short-course corticosteroid-induced pulmonary and apparent cerebral aspergillosis in a patient with idiopathic thrombocytopenic purpura. Blood. 2001 Nov 1;98(9):2875-7. doi: 10.1182/blood.v98.9.2875a. No abstract available.

  PMID: 11697337 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

• 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

• Coopamah MD, Garvey MB, Freedman J, Semple JW. Cellular immune mechanisms in autoimmune thrombocytopenic purpura: An update. Transfus Med Rev. 2003 Jan;17(1):69-80. doi: 10.1053/tmrv.2003.50004.

  PMID: 12522773 BACKGROUND

• Cines DB, Bussel JB, Liebman HA, Luning Prak ET. The ITP syndrome: pathogenic and clinical diversity. Blood. 2009 Jun 25;113(26):6511-21. doi: 10.1182/blood-2009-01-129155. Epub 2009 Apr 24.

  PMID: 19395674 BACKGROUND

• 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

• Zaja F, Battista ML, Pirrotta MT, Palmieri S, Montagna M, Vianelli N, Marin L, Cavallin M, Bocchia M, Defina M, Ippoliti M, Ferrara F, Patriarca F, Avanzini MA, Regazzi M, Baccarani M, Isola M, Soldano F, Fanin R. Lower dose rituximab is active in adults patients with idiopathic thrombocytopenic purpura. Haematologica. 2008 Jun;93(6):930-3. doi: 10.3324/haematol.12206. Epub 2008 Apr 9.

  PMID: 18403395 BACKGROUND

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  PMID: 12611000 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Cyclosporine; Rituximab; Steroids

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

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Fused-Ring Compounds

Study Officials

• Mohammad Elyamany, Prof.

  Yamany1@yahoo.com

  STUDY DIRECTOR

• Shymaa Mohamed Nageeb, MD

  Shymaanageeb1993@gmail.com

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Safaa A Khaled, Ass. Prof.

CONTACT

01064170058; safaakhaled2003@gmail.com

Shymaa Mohamed Nageeb, MD

CONTACT

01032165735; Shymaanageeb1993@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assisstant professor

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 3, 2019
• Study Start: November 1, 2019
• Primary Completion: November 1, 2020
• Study Completion: December 1, 2020
• Last Updated: November 1, 2019

Record last verified: 2019-10