ITP - Immune ThrombocytopeniaRESTINCT06919341

RESTI Registry: Spanish Registry of Primary Immune Thrombocytopenia and Other Immune Thrombocytopenia

An observational study of ITP - Immune Thrombocytopenia and Primary Immune Thrombocytopenia (ITP), run by Fundación Española de Hematología y Hemoterapía at 36 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Primary immune thrombocytopenia (PIT), previously referred to as idiopathic thrombocytopenic purpura, is an acquired disease characterized by accelerated platelet destruction and deficient platelet production by megakaryocytes. Read more about this study

Who is it for?: Ages 2 months and older
Conditions the study is for: ITP - Immune Thrombocytopenia, Primary Immune Thrombocytopenia (ITP)
How many people: 1,000 participants
Where: 36 sitesSpain
Study dates: 27 Sep 2024to Sep 2034
How long will I take part?: 1 Year
Phase: Observational

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 2 months and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: People with the diagnostic presumption of PIT or other thrombocytopenia of probable immune origin defined as a platelet count < 100 x 109/L.

Who may be able to join

Children as young as 2 months of age and adults in follow-up since 2015 (irrespective of date of diagnosis) with the diagnostic presumption of PIT or other thrombocytopenia of probable immune origin defined as a platelet count < 100 x 109/L.
Patients who have given written informed consent. In the case of deceased patients, the data will be included in the registry and the investigator will record the impossibility of collecting patient's informed consent form due to death. Only patients deceased after December 31 2015, will be included

Who cannot join

Patients who, at the investigator's discretion, do not meet the conditions for inclusion in the study

Trial locations and contacts

36 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Cristina Pascual Izquierdo, MD contact

91 586 8445

sehh@sehh.es

Amanda López Picado contact

646075853

sehh@sehh.es

City, postcode or hospital

Sites recruiting now only

36 sites in 1 country

Spain36 sites, 36 recruiting

Complexo Hospitalario Universitario A Coruña
A Coruña, A Coruña, 15006
María del Carmen Gómez Del Castillo Solano, MD, 034 + 981 17 80 00, sehh@sehh.es
Recruiting
Hospital Universitario Punta de Europa
Algeciras, Cádiz, 11207
Alberto Casaus Garcia, MD, 034+ 956 02 50 00, sehh@sehh.es
Recruiting
Hospital Del Mar
Barcelona, Barcelona, 08003
Blanca Sánchez González, MD, 034 + 93 248 30 00, sehh@sehh.es
Recruiting
Hospital Vall d'Hebron (
Barcelona, Barcelona, 08035
David Valcárcel Ferreiras, 034 + 934 89 30 00, sehh@sehh.es
Not yet recruiting
Hospital de Basurto
Bilbao, Biskaia, 48013
Laura Hernández Vázquez, 034 + 944 00 60 00, sehh@sehh.es
Recruiting
Hospital Puerta del Mar
Cadiz, Cádiz, 11009
María Yera Cobo, MD, 034 + 956 00 21 00, sehh@sehh.es
Recruiting
Hospital de La Plana
Castellon, Castellón, 12540
Silvia Bernat Pablo, 034 + 964399775, sehh@sehh.es
Recruiting
Hospital Universitario Reina Sofia de Córdoba
Córdoba, Córdoba, 14004
Mª Carmen Fernandez Sanchez de Mora, MD, 034+ 957 01 00 00, sehh@sehh.es
Recruiting
Hospital Universitario Virgen de las Nieves
Granada, Granada, 18014
Laura Entrena Ureña, MD, 034+ 958 02 00 00, sehh@sehh.es
Recruiting
Hospital Juan Ramón Jimenez
Huelva, Huelva, 21005
Bianca Dí-az Roldan, MD, 034+ 959 01 60 00, sehh@sehh.es
Recruiting
Complejo Hospitalario de Jaén
Jaén, Jaén, 23007
María Nieto Hernández, MD, 034+ 953 00 80 00, sehh@sehh.es
Recruiting
Hospital Universitario de Jerez
Jerez de la Frontera, Cádiz, 11407
Rosa María Campos Álvarez, MD, 034+ 956 03 20 00, sehh@sehh.es
Recruiting
Hospital Universitario Arnau de Vilanova
Lleida, Lérida, 25198
Armando Galán, MD, 034 + 973 24 81 00, sehh@sehh.es
Not yet recruiting
Hospital Universitario Lucus Augusti
Lugo, Lugo, 27003
Alvaro Lorenzo Vizcaya, MD, 034 + 982 29 60 00, sehh@sehh.es
Recruiting
Hospital Infantil Universitario Niño Jesús
Madrid, Madrid, 28009
Elena Sebastián Pérez, MD, 915 03 59 00, sehh@sehh.es
Recruiting
Hospital Clínico San Carlos
Madrid, Madrid, 28040
Estefanía Bolaños Calderón, 034+ 913 30 30 00, sehh@sehh.es
Recruiting
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, 28040
Cristina Pascual Izquierdo, MD, 034+ 913191998, sehh@sehh.es
Recruiting
Hospital Universitario 12 octubre
Madrid, Madrid, 28041
Denis Zafra Torres, MD, 034 + 913 90 80 00, sehh@sehh.es
Recruiting
Hospital Universitario La Paz
Madrid, Madrid, 28046
Mª Teresa Álvarez Román, MD, 034 + 917 27 70 00, sehh@sehh.es
Not yet recruiting
Hospital Universitario Regional de Málaga
Málaga, Málaga, 29010
Francisco José López Jaime, MD, 034+ 951 29 00 00, sehh@sehh.es
Recruiting
Hospital Universitario Virgen de la Victoria
Málaga, Málaga, 29010
Isabel Socorro Caparrós Miranda, MD, 034 + 951 03 20 00, sehh@sehh.es
Recruiting
Hospital materno infantil de Málaga
Málaga, Málaga, 29011
Mª Rosario Prieto Bonilla, MD, 034+ 951 29 00 00, sehh@sehh.es
Recruiting
Hospital Universitario Costa del Sol
Marbella, Málaga, 29603
Mª Esperanza Moreno Beltrán, MD, 034 + 951 97 66 69, sehh@sehh.es
Recruiting
Hospital de la Merced
Osuna, Sevilla, 41640
Rocío Cardesa Cabrera, 034 + 955 07 72 00, sehh@sehh.es
Not yet recruiting
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
Daniel Martínez Carballeira, MD, 034+ 985 10 80 00, sehh@sehh.es
Recruiting
Hospital Universitario Son Espases
Palma, Balearic Islands, 07120
Mariana Canaro, MD, 034 + 871 20 50 00, sehh@sehh.es
Recruiting
Hospital Universitario de Navarra
Pamplona, Navarre, 31008
Montse Alvarellos Outeiro, MD, 034 + 848 42 22 22, sehh@sehh.es
Recruiting
Hospital de la Serranía de Ronda
Ronda, Málaga, 29400
Reyes Jiménez Bárcenas, MD, 034 + 951 06 50 00, sehh@sehh.es
Recruiting
Complejo Asistencial Universitario de Salamanca
Salamanca, Salamanca, 37007
José María Bastida Bermejo, 034+ 923 29 11 00, sehh@sehh.es
Not yet recruiting
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38320
Sunil Lakhwani, 034 + 922 67 80 00, sehh@sehh.es
Recruiting
Hospital Universitario Virgen de la Macarena
Seville, Sevilla, 41009
Gloria García-Donas Gabaldón, MD, 0340 + 955 00 80 00, sehh@sehh.es
Recruiting
Hospital Universitario Virgen del Rocio
Seville, Sevilla, 41013
MARIA EVA MINGOT CASTELLANO, MD, 034+ 955 01 20 00, sehh@sehh.es
Recruiting
Hospital Universitario Mutua Terrassa
Terrassa, Barcelona, 08221
Silvia Del Rocio Verdesoto Cozzarelli, MD, 034 + 937 36 50 50, sehh@sehh.es
Not yet recruiting
Hospital Sierrallana
Torrelavega, Cantabria, 39300
Amalia Cuesta García, 034+ 942 84 74 00, sehh@sehh.es
Not yet recruiting
Hospital Clínico de Valencia
Valencia, Valencia, 46010
Marisa Calabuig Muñoz, 034 + 961 97 35 00, sehh@sehh.es
Recruiting
Hospital Universitario Miguel Servet
Zaragoza, Zaragoza, 50009
Gonzalo Caballero Navarro, MD, 034+ 976 76 55 00, sehh@sehh.es
Recruiting

Other trials in Spain

About this study

Although the existence of PIT has been known for decades, there is no consensus on its triggering mechanisms. On the other hand, this disease presents a very heterogeneous patient profile, both in its characteristics and treatments. In this sense, the diagnosis is still made by excluding other causes of thrombocytopenia.

There is insufficient epidemiological data on the disease, a fact that is especially evident in our country. We have no data on the incidence or prevalence of this pathology in Spain.

For all these reasons, this epidemiological study has been designed to increase the available knowledge about this disease and the detailed characterization of the population of patients with ITP in Spain.

The main objective of this study is to describe the clinical, analytical and treatment characteristics of primary immune thrombocytopenia and other immune thrombocytopenia.

The study is an epidemiological, ambispective, multicenter study carried out in hospitals in Spain.

Information will be collected on the disease under study, as well as on the treatments received, using the patient's clinical history as a source document.

Conditions: ITP - Immune Thrombocytopenia, Primary Immune Thrombocytopenia (ITP)
Keywords: ITP, PTI, Trombocitopenia inmune primaria, Primary Inmune Thrombocytopenia
Medical subject headings: Purpura, Thrombocytopenic, Idiopathic

What is being measured

The primary outcome is the main question the study is designed to answer.

Description of the clinical and analytical features of PIT and other immune thrombocytopenias.
Measured: From enrollment

Secondary outcomes (4)

Comparison with published historical ITP data
Measured: From enrollment
Definition of therapeutic strategies and most common treatments in ITP
Measured: From enrollment
Evaluation of response to first-line treatment
Measured: From enrollment
Evaluation of response to subsequent treatments
Measured: From enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Sep 2024Sep 2034

First posted9 Apr 2025
Study start27 Sep 2024
Primary completionSep 2034 (estimated)
Study completionSep 2034 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ITP - Immune ThrombocytopeniaStudies 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: Other
Enrolment: 1,000 participants (estimated)
Target duration: 1 Year

IDs, dates and publications

ClinicalTrials.gov ID: NCT06919341
Sponsor's protocol ID: RESTI
Acronym: RESTI
Status last verified: Mar 2025
First submitted: 29 Mar 2025
Last updated: 9 Apr 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Cristina Pascual Izquierdo, MD

91 586 8445

sehh@sehh.es

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 3
A Study Investigating Intravenous Human Normal Immunoglobulin 10% in Adults With Chronic Immune Thrombocytopenia (ITP)
Chronic Primary Immune Thrombocytopenia (ITP)
RecruitingPhase 2
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
Active, not recruitingPhase 2
A Study of Ianalumab (VAY736) in Patients With Primary Immune Thrombocytopenia (ITP) Previously Treated With at Least Two Lines of Therapies
Primary Immune Thrombocytopenia (ITP)
RecruitingPhase 1/2
Safety and Preliminary Efficacy of CTX112 in Adult Participants With Relapsed/Refractory Hematologic Autoimmune Disease
Warm Autoimmune Hemolytic Anemia (WAIHA), ITP - Immune Thrombocytopenia
RecruitingPhase 2/3
A Study of Efgartigimod IV in Participants From 12 Years to Less Than 18 Years of Age With Chronic Immune Thrombocytopenia (ITP)
Immune Thrombocytopenia (ITP), ITP - Immune Thrombocytopenia

All ITP - Immune Thrombocytopenia trials