ITP - Immune Thrombocytopenic PurpuraNCT04113915
Viral Hepatitis B and C Infection in Patients With Idiopathic Thrombocytopenic Purpura Treated With Triple Therapy
An observational study of ITP - Immune Thrombocytopenic Purpura and Viral Hepatitis, run by Safaa AA Khaled.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- ITP - Immune Thrombocytopenic Purpura, Viral Hepatitis
- What is being tested?
- triple therapy and Steroids
- Type of treatment
- Pill or oral medicine
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Nov 2019to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- ITP patients received triple therapy or steroids only more than 18 years old
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed description
Primary immune thrombocytopenia (ITP) is an autoimmune disorder characterized by isolated thrombocytopenia in the absence of other causes.ITP is mediated by antiplatelet autoantibodies. Antibody-coated platelets are phagocytosed by macrophages in the reticuloendothelial system, leading to accelerated platelet clearance. Macrophages also act as antigen-presenting cells interacting with CD8+ and CD4+ T cells that in turn stimulate antibody-producing B cells.This pathogenic loop sustains autoantibody production. T cell-mediated platelet lysis and megakaryocyte immunoinjury contribute to the diverse pathobiology of ITP.
Single-agent treatments have not been successful at inducing prolonged remission.With immunosuppressive monotherapy, ITP patients usually require prolonged treatment, leading to unpleasant and sometimes serious side effects.
Recent studies combining dexamethasone and rituximab in short courses have reported encouraging results.it is postulated that adding cyclosporine to this combination may induce a more enduring remission by also targeting T cells and thereby briefly suppressing all 3 immune cell types implicated in sustaining the pathogenic loop.
Suppressing these cells simultaneously has a risk of predisposing to serious infections.it is considered it appropriate to conduct a pilot study on a small number of patients with the aim of investigating the safety and efficacy of the triple therapy.
Infectious complications, mainly caused by the use of corticosteroids and other immunosuppressive agents, are a major cause of morbidity in patients with cITP. Moreover, infections may trigger autoimmune diseases and, at least theoretically, may be a complication of an already impaired immune system. It has been reported that children have an increased incidence of infection before diagnosis of ITP.
Hepatitis B (HBV) and C (HCV) virus infections are blood-borne viruses that pose major public health threats worldwide. The World Health Organization (WHO) report released in April 2017 on the status of hepatitis worldwide documented that 1.75 million new cases of HCV infection occurred in 2015, with about 71 million people already infected, the Eastern Mediterranean region has the highest HCV prevalence rate in the world According to WHO, in 2017 Egypt had the highest HCV prevalence rate in the world . According to the IHME in 2016, there were 4,002,706 men and 3,757,236 women with chronic HCV. HCV prevalence was estimated to be 11.9% among the general population (populations at relatively low risk of exposure to HCV, such as healthy children, blood donors, antenatal clinic attendees and pregnant women), 55.6% among populations at high risk (PWID, hemodialysis, multitransfused individuals and hemophiliacs), 14.3% among populations at intermediate risk (household contacts of HCV-infected individuals, prisoners, individuals with diabetes and healthcare workers), 56.0% among populations with liver-related conditions (acute viral hepatitis, liver cirrhosis, chronic liver disease, hepatocellular carcinoma and non-Hodgkin's lymphoma) and 35.0% among special clinical populations (dermatological manifestations, rheumatologic disorders and non-liver-related malignancies Thrombocytopenia can also complicate bleeding manifestations such as variceal bleeding. It may impede the initiation and continuation of antiviral therapy, potentially decreasing the probability of successful HCV reatment.Recent studies have evaluated the underlying mechanism of thrombocytopenia in chronic HCV infection and assessed the usefulness of several therapeutic options.
Besides hepatic complications, chronic HCV infection is also associated with several extra-hepatic manifestations including thrombocytopenia. Thrombocytopenia in chronic Hcv infection is a major problem, particularly in patients with advanced liver disease. The risk of serious bleeding with severe thrombocytopenia can prevent invasive procedures including biopsies for staging.
The pathophysiology of thrombocytopenia in patients with HCV infection is thought to be multifactorial. Besides inducing an autoimmune reaction with production of antiplatelet antibodies, the virus also causes direct bone marrow suppression with resulting thrombocytopenia , chronic HCV infection induced liver fibrosis and cirrhosis leads to portal hypertension with subsequent hypersplenism and sequestration of platelets, decreased the production of thrombopoeitin, and endothelial dysfunction, all of which can contribute to thrombocytopenia.Although uncommonly used in developed countries, interferon (IFN) and ribavirin used as part of anti-HCV therapy can also contribute to low platelet count.Hepatitis B virus (HBV) infection represents a significant global health problem, since almost one third of the worlds population has serological signs of previous or present infection, and that 240 million individuals are chronic hepatitis B surface antigen (HBsAg) carriers. Worldwide, low rates of serological HBsAg positivity (0.2%-0.5%) and signs of previous HBV contact [4%-6% HBsAg negative/anti-hepatitis B core antigen antibodies (anti-HBc)positive subjects] are registered in north western and central Europe, north America and Australia. On the contrary, the highest prevalences are reported in China, Southeast Asia and tropical Africa (chronicinfection 8%-20%, and previous exposure 70%-95%,respectively).
It is presently well known that medications such as glucocorticoids and anticancer treatments can interfere with the host immune system and blunt the control that it exerts over HBV replication, with the potential to cause viral reactivation (HBVr) in both HBsAg positive patients and individuals with serological signs of previous resolved HBV exposure. HBVr can assume various manifestations, spanning from asymptomatic hepatitis to life threatening fulminant liver failure. This risk is most common among patients undergoing treatment for hematological tumors or those receiving hematopoietic stem cell transplantation (HSCT). Nevertheless, also patients with solid tumors, immunological diseases and inflammatory bowel diseases are exposed to the risk of HBVr.The existence of an effective vaccination and a mature treatment schedule for HBV suggests that the potential for elimination of this virus as a major public health problem in Egypt exists. In a challenging economic climate, effective targeting of prevention and treatment strategies for both HBV and HCV is essential to make best use of limited resources in Egypt, however. Recent modelling work on HCV illustrates the potential power of intervention targeting in both reducing the risk of infection spread, and improving treatment outcomes, in the Egyptian context.
- Being tested
- triple therapy, Steroids
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
triple therapyDrug
Also called High dose dexamethasone together with cyclosporin and rituximab
Effect of treatment on immunity to obtain infection with hepatitis B\&C
SteroidsDrug
Also called Parenteral decadrone or oral hostacortine
Oral or parenteral steroid therapy for ITP
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Group of ITP patients received triple therapy Receives: Drug: triple therapy | |
| Group 2 | Group of ITP patients received steroids Receives: Drug: Steroids | |
| Group 3 | Normal control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study startNov 2019 (estimated)
- Primary completionNov 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for ITP - Immune Thrombocytopenic PurpuraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Safaa AA Khaled
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Safaa AA Khaled, Assiut University
- Investigators
- Mohammad Elyamany, Prof., Study director, Yamany1@yahoo.comShymaa Mohamed Nageeb, MD, Principal investigator, Shymaanageeb1993@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04113915
- Sponsor's protocol ID
- Viral hepatitis in ITP
- Status last verified
- Oct 2019
- First submitted
- 1 Oct 2019
- Last updated
- 1 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25972158Norgaard 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.
PubMed 21263148Kramar 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.
PubMed 19073996Provan 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.
PubMed 19846889Neunert 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.
PubMed 21325604Zaja 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.
PubMed 20130241McMillan 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.
PubMed 14576051Gomez-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.
PubMed 23470153Bussel 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.
PubMed 24747949Gudbrandsdottir 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.
PubMed 23293082Apostolidis 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.
PubMed 11697337Patel 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.
PubMed 22566601Kuwana 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.
PubMed 15765777Coopamah 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.
PubMed 12522773Cines 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.
PubMed 19395674
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Viral Hepatitis B and C Infection in Patients With Idiopathic Thrombocytopenic Purpura Treated With Triple Therapy
- ClinicalTrials.gov ID
- NCT04113915
- Acronym / sponsor ID
- Viral hepatitis in ITP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Safaa AA KhaledUniversity, hospital or other
- Study start
- Nov 2019 (estimated)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 3 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary immune thrombocytopenia (ITP) is an autoimmune disorder characterized by isolated thrombocytopenia in the absence of other causes.ITP is mediated by antiplatelet autoantibodies. Antibody-coated platelets are phagocytosed by macrophages in the reticuloendothelial system, leading to accelerated platelet clearance. Macrophages also act as antigen-presenting cells interacting with CD8+ and CD4+ T cells that in turn stimulate antibody-producing B cells.This pathogenic loop sustains autoantibody production. T cell-mediated platelet lysis and megakaryocyte immunoinjury contribute to the diverse pathobiology of ITP.
Single-agent treatments have not been successful at inducing prolonged remission.With immunosuppressive monotherapy, ITP patients usually require prolonged treatment, leading to unpleasant and sometimes serious side effects.
Recent studies combining dexamethasone and rituximab in short courses have reported encouraging results.it is postulated that adding cyclosporine to this combination may induce a more enduring remission by also targeting T cells and thereby briefly suppressing all 3 immune cell types implicated in sustaining the pathogenic loop.
Suppressing these cells simultaneously has a risk of predisposing to serious infections.it is considered it appropriate to conduct a pilot study on a small number of patients with the aim of investigating the safety and efficacy of the triple therapy.
Infectious complications, mainly caused by the use of corticosteroids and other immunosuppressive agents, are a major cause of morbidity in patients with cITP. Moreover, infections may trigger autoimmune diseases and, at least theoretically, may be a complication of an already impaired immune system. It has been reported that children have an increased incidence of infection before diagnosis of ITP.
Hepatitis B (HBV) and C (HCV) virus infections are blood-borne viruses that pose major public health threats worldwide. The World Health Organization (WHO) report released in April 2017 on the status of hepatitis worldwide documented that 1.75 million new cases of HCV infection occurred in 2015, with about 71 million people already infected, the Eastern Mediterranean region has the highest HCV prevalence rate in the world According to WHO, in 2017 Egypt had the highest HCV prevalence rate in the world . According to the IHME in 2016, there were 4,002,706 men and 3,757,236 women with chronic HCV. HCV prevalence was estimated to be 11.9% among the general population (populations at relatively low risk of exposure to HCV, such as healthy children, blood donors, antenatal clinic attendees and pregnant women), 55.6% among populations at high risk (PWID, hemodialysis, multitransfused individuals and hemophiliacs), 14.3% among populations at intermediate risk (household contacts of HCV-infected individuals, prisoners, individuals with diabetes and healthcare workers), 56.0% among populations with liver-related conditions (acute viral hepatitis, liver cirrhosis, chronic liver disease, hepatocellular carcinoma and non-Hodgkin's lymphoma) and 35.0% among special clinical populations (dermatological manifestations, rheumatologic disorders and non-liver-related malignancies Thrombocytopenia can also complicate bleeding manifestations such as variceal bleeding. It may impede the initiation and continuation of antiviral therapy, potentially decreasing the probability of successful HCV reatment.Recent studies have evaluated the underlying mechanism of thrombocytopenia in chronic HCV infection and assessed the usefulness of several therapeutic options.
Besides hepatic complications, chronic HCV infection is also associated with several extra-hepatic manifestations including thrombocytopenia. Thrombocytopenia in chronic Hcv infection is a major problem, particularly in patients with advanced liver disease. The risk of serious bleeding with severe thrombocytopenia can prevent invasive procedures including biopsies for staging.
The pathophysiology of thrombocytopenia in patients with HCV infection is thought to be multifactorial. Besides inducing an autoimmune reaction with production of antiplatelet antibodies, the virus also causes direct bone marrow suppression with resulting thrombocytopenia , chronic HCV infection induced liver fibrosis and cirrhosis leads to portal hypertension with subsequent hypersplenism and sequestration of platelets, decreased the production of thrombopoeitin, and endothelial dysfunction, all of which can contribute to thrombocytopenia.Although uncommonly used in developed countries, interferon (IFN) and ribavirin used as part of anti-HCV therapy can also contribute to low platelet count.Hepatitis B virus (HBV) infection represents a significant global health problem, since almost one third of the worlds population has serological signs of previous or present infection, and that 240 million individuals are chronic hepatitis B surface antigen (HBsAg) carriers. Worldwide, low rates of serological HBsAg positivity (0.2%-0.5%) and signs of previous HBV contact [4%-6% HBsAg negative/anti-hepatitis B core antigen antibodies (anti-HBc)positive subjects] are registered in north western and central Europe, north America and Australia. On the contrary, the highest prevalences are reported in China, Southeast Asia and tropical Africa (chronicinfection 8%-20%, and previous exposure 70%-95%,respectively).
It is presently well known that medications such as glucocorticoids and anticancer treatments can interfere with the host immune system and blunt the control that it exerts over HBV replication, with the potential to cause viral reactivation (HBVr) in both HBsAg positive patients and individuals with serological signs of previous resolved HBV exposure. HBVr can assume various manifestations, spanning from asymptomatic hepatitis to life threatening fulminant liver failure. This risk is most common among patients undergoing treatment for hematological tumors or those receiving hematopoietic stem cell transplantation (HSCT). Nevertheless, also patients with solid tumors, immunological diseases and inflammatory bowel diseases are exposed to the risk of HBVr.The existence of an effective vaccination and a mature treatment schedule for HBV suggests that the potential for elimination of this virus as a major public health problem in Egypt exists. In a challenging economic climate, effective targeting of prevention and treatment strategies for both HBV and HCV is essential to make best use of limited resources in Egypt, however. Recent modelling work on HCV illustrates the potential power of intervention targeting in both reducing the risk of infection spread, and improving treatment outcomes, in the Egyptian context.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: triple therapyGroup of ITP patients received triple therapy |
| Group 2 | – | Drug: SteroidsGroup of ITP patients received steroids |
| Group 3 | – | –Normal control group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- ITP patients received triple therapy or steroids only more than 18 years old
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| triple therapyAlso: High dose dexamethasone together with cyclosporin and rituximabEffect of treatment on immunity to obtain infection with hepatitis B\&C | Drug | Group 1 |
| SteroidsAlso: Parenteral decadrone or oral hostacortineOral or parenteral steroid therapy for ITP | Drug | Group 2 |
Primary outcome
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
Time frame: 1 year
1 secondary outcome
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
Time frame: 1year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- Background: PubMed 25972158Choi 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.
- Background: PubMed 21263148Norgaard 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.
- Background: PubMed 19073996Kramar 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.
- Background: PubMed 19846889Provan 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.
- Background: PubMed 21325604Neunert 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.
- Background: PubMed 20130241Zaja 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.
- Background: PubMed 14576051McMillan 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.
- Background: PubMed 23470153Gomez-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.
- Background: PubMed 24747949Bussel 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.
- Background: PubMed 23293082Gudbrandsdottir 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.
- Background: PubMed 11697337Apostolidis 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.
- Background: PubMed 22566601Patel 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad Elyamany, Prof. study director
Yamany1@yahoo.com
Shymaa Mohamed Nageeb, MD principal investigator
Shymaanageeb1993@gmail.com
Questions about this trial
What is this clinical trial studying?
An observational study of ITP - Immune Thrombocytopenic Purpura and Viral Hepatitis, run by Safaa AA Khaled.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Safaa A Khaled, Ass. Prof. (01064170058 ext. 002, safaakhaled2003@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04113915, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2019.