- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00504075
A Study to Find How Safe and Effective GAMMAPLEX® is in Subjects With Chronic Idiopathic Thrombocytopenic Purpura (ITP)
A Phase III, Multicenter, Open-Label Study To Evaluate the Efficacy and Safety of GAMMAPLEX® in Chronic Idiopathic Thrombocytopenic Purpura
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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Buenos Aires, Argentina, C1280AEB
- Hospital Británico
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Buenos Aires, Argentina, C1122AAL
- I. A. D. T. (Instituto Argentino de Diagnóstico y Tratamiento)
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Buenos Aires, Argentina, C1431FWO
- Centro de Educación Médica e Investigaciones Clinicas Dr. Norberto Quirno (CEMIC)
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Cordoba, Argentina, X5016KEH
- Hospital Privado de Cordoba
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Corrientes, Argentina
- J.R. Vidal Hospital
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San Juan, Argentina, 5400
- CER San Juan
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Buenos Aires
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Capital Federal, Buenos Aires, Argentina, C1437JCP
- Hospital Churruca
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La Plata, Buenos Aires, Argentina, B1900AXU
- Hospital Italiano de La Plata
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Sante Fe
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Rosario, Sante Fe, Argentina, S2000JKR
- Instituto de Diagnóstico Hematológico Ambulatorio (IDHEA)
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New Delhi, India, 110060
- Sir Ganga Ram Hospital
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Andhra Pradesh
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Hyderabad, Andhra Pradesh, India, 500003
- Apollo Hospitals
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Hyderabad, Andhra Pradesh, India, 500054
- Mahavir Hospital
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Suryarao pet, Vijayawada, Andhra Pradesh, India, 520002
- City Cancer Centre,
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Bangalore
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Karnataka, Bangalore, India, 560054
- M. S Ramaiah Hospital
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Gujarat
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Ahmedabad, Gujarat, India, 380009
- Vedanta
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Ahmedabad, Gujarat, India, 380061
- Gurukrupa Hospital
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Gokal Nagar, Karamsad, Gujarat, India, 388325
- M S Patel Cancer Centre, Shree Krishna Hospital
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Karnataka
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Bangalore, Karnataka, India, 560017
- Manipal Hospital
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Mangalore, Karnataka, India, 575002
- Father Muller Medical College Hospital
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Mangalore, Karnataka, India, 5750003
- Vinaya Hospital & research Centre
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Mangalore, Karnataka, India, 575001
- Kasturba Medical College, Manipal Acunova KMC Research Centre
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Maharashtra
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Pune, Maharashtra, India, 411004
- Deenanath Mangeshkar Hospital
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Rajasthan
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Jaipur, Rajasthan, India, 300201
- S.K. Soni Hospital Sect 5
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Florida
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Orange City, Florida, Stati Uniti, 32763
- Mid Florida Hematology & Oncology
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Illinois
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Chicago, Illinois, Stati Uniti, 60612
- Rush University Medical Center
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Maryland
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Bethesda, Maryland, Stati Uniti, 20817
- Center for Cancer & Blood Disorders
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New York
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New York, New York, Stati Uniti, 10021
- New York Hospital / Cornell University, Division of Pediatrics
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Stony Brook, New York, Stati Uniti, 11794-8111
- Department of Pediatrics, SUNY at Stony Brook
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Oregon
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Portland, Oregon, Stati Uniti, 97239
- Oregon Health & Science University
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Texas
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San Antonio, Texas, Stati Uniti, 78229
- Cancer Care Centers of South Texas
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Males and females aged between 18 and 70 years.
- Confirmed diagnosis of chronic ITP of at least 6 months duration.
- Platelet count of less than or equal to 20 x 10 9/L at enrollment.
- Absence of other conditions that, in the opinion of the investigator, could cause thrombocytopenia.
- If subjects were treated with corticosteroids the treatment regimen/dose must have been stable (for a minimum of 2 weeks before screening). The dose of corticosteriod or other immunosuppressant should have remained constant until Day 32. 6) If subjects were being treated with cyclophosphamide, azathioprine or attenuated androgens, the treatment regimen and dose must have been stable for a minimum of 2 months before Day 1. The dose of corticosteriod or other immunosuppressant should have remained constant until Day 32. 7) Splenectomized subjects and both Rh(D)+ and Rh(D)- subjects may be included.
8) The subject has signed an informed consent form (subjects must be at least 18 years old), and/or the subject's legal guardian has signed the informed consent form if indicated 9) If a subject is a female of child-bearing potential, she must have a negative result on a urine-based HCG pregnancy test.
10) If a subject is a female who is or becomes sexually active, she must practice contraception by using a method of proven reliability for the duration of the study.
Exclusion Criteria:
- A history of any severe or anaphylactic reaction to blood or any blood-derived product, or any severe reaction to IGIV or any other IgG preparation.
- Intolerance to any component of the investigational product.
- Received any live virus vaccine within the last 3 months prior to Day1.
- Received an IGIV preparation within 1 month prior to Day 1.
- Were currently receiving, or has received, any investigational agent within the 1 month prior to Day 1.
- Received any blood, blood product, or blood derivative within the 1 month prior to Day 1.
- Received Rituximab within the 3 months before Day 1.
- Pregnant or nursing.
- Tested positive for any of the following at screening: HBsAg, NAT for HCV, NAT for HIV, Antibodies to HCV or HIV 1 or 2.
- Had levels greater than 2.5 times the upper limit of normal at screening, as defined by the central laboratory, of alanine aminotransferase or aspartate aminotransferase.
- Had severe renal impairment (defined as serum creatinine greater than 2 times the upper limit of normal or BUN greater than 2.5 times the upper limit of normal for the range of the laboratory doing the analysis); on dialysis; a history of acute renal failure.
- Known to have abused alcohol, opiates, psychotropic agents, or other chemicals or drugs within the past 12 months.
- History of deep vein thrombosis (DVT) or thrombotic complications of IGIV therapy.
- Any history or sign of hyperviscosity, transient ischemic attack (TIA), stroke, other thromboembolic event, or unstable angina.
- Suffered from any acute or chronic medical conditions (e.g., renal disease or predisposing conditions for renal disease, coronary artery disease, or protein losing enteropathy) that, in the opinion of the investigator, may interfere with the conduct of the study.
- An acquired medical condition, such as chronic lymphocytic leukemia, lymphoma, multiple myeloma, chronic or recurrent neutropenia (defined as an absolute neutrophil count (ANC) < 1 x 109/L).
- Non-controlled arterial hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >90 mmHg).
- Anemic (hemoglobin <10 g/dL) at screening.
- Unlikely to adhere to the protocol requirements of the study or is likely to be uncooperative.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Gammaplex (intravenous immunoglobulin)
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Dosage form: Gammaplex® is a sterile liquid of 5 % w/v normal immunoglobulin. Gammaplex® contains 5 g/100 mL of human normal immunoglobulin (i.e. 50 g/L, of which virtually 100% is IgG). The first course of GAMMAPLEX will be administered as an intravenous infusion of 1 g/kg on each of 2 consecutive days. If required, a further 1 or 2 courses on the same dosage regimen may be administered in the period Day 32 to Day 90 following the first course of GAMMAPLEX.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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The Number of Subjects With Chronic ITP Treated With Gammaplex Whose Platelet Count Reached a Threshold of 50 x 10^9/L.
Lasso di tempo: 9 days
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The number of subjects with chronic ITP treated following treatment with Gammaplex who attained a platelet count of ≥ 50 x 10^9/L by Day 9.
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9 days
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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The Safety of GAMMAPLEX at the Dosage Used in This Study.
Lasso di tempo: AEs were documented from the date the informed consent form was signed until the End of Study visit on Day 90.
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The safety variables used to assess safety were the following:
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AEs were documented from the date the informed consent form was signed until the End of Study visit on Day 90.
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Duration of Time That the Platelet Count of Subjects With Chronic ITP Treated With Gammaplex Remained ≥ 50 x 10^9/L.
Lasso di tempo: Days 1, 2, 3, 5, 9, 14, 21, 32.
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Blood samples were collected to measure platelet counts and the duration of time for which the platelet count remained ≥50 x 10^9/L was measured.
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Days 1, 2, 3, 5, 9, 14, 21, 32.
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Tim J Aldwinckle, MD, Bio Products Laboratory
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Processi patologici
- Malattie del sistema immunitario
- Malattie autoimmuni
- Malattie ematologiche
- Emorragia
- Disturbi emorragici
- Disturbi della coagulazione del sangue
- Manifestazioni cutanee
- Trombocitopenia
- Disturbi delle piastrine del sangue
- Microangiopatie trombotiche
- Porpora
- Porpora, Trombocitopenica
- Porpora, Trombocitopenica, Idiopatica
- Effetti fisiologici delle droghe
- Fattori immunologici
- Anticorpi
- Immunoglobuline
- Immunoglobuline, per via endovenosa
- gamma-globuline
- Immunoglobulina Rho(D).
Altri numeri di identificazione dello studio
- GMX02
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Gammaplex, intravenous immunoglobulin
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Braintree LaboratoriesCompletato
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Bio Products LaboratoryCompletatoImmunodeficienza variabile comune | Disturbi da immunodeficienza primaria | Sindrome da iper-IgM | Agammaglobulinemia legata all'XStati Uniti, Regno Unito, Ungheria
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Bio Products LaboratoryCompletatoImmunodeficienza primaria | Sindrome di Wiskott-Aldrich | Ipogammaglobulinemia | Ipogammaglobulinemia variabile comune | Ipogammaglobulinemia legata all'X | Immunodeficienza con iper-IgMStati Uniti
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Bio Products LaboratoryCompletatoImmunodeficienza variabile comune | Sindrome di Wiskott-Aldrich | Agammaglobulinemia legata all'X | Disturbi da immunodeficienza primaria | Sindrome da iper-IgMStati Uniti, Chile, Israele
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Isaac MelamedBio Products LaboratorySconosciutoDisturbo autistico | Autismo | Disturbo di Asperger | Disturbo pervasivo dello sviluppo | PDDStati Uniti
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Fundacion GESICAMerck Sharp & Dohme LLCReclutamentoInfezioni da Flavivirus | DengueArgentina