- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00861224
Effects of Long-term Dosing of AMG 531 on Bone Marrow Morphology
The Effects of Long-term Dosing of AMG 531 on Bone Marrow Morphology in Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This study is to be performed in conjunction with the phase 3 treatment studies (20030105 and 20030212) and with the open label extension study (20030213).
Subjects who are screening for participation in the phase 3 studies will be asked to consider participation in this bone marrow study. At least 10 subjects from each of the two phase 3 studies (20030105 and 20030212) will enroll in this study. This will ensure enrollment of subjects who are both non-splenectomized and splenectomized.
All subjects who participate must have had a bone marrow biopsy within one year prior to enrollment, and must release the tissue block to Amgen for interpretation by a central pathology laboratory. Subjects that do not have a historical bone marrow within one year (with available tissue block) must have a baseline bone marrow biopsy and aspirate performed prior to dosing with AMG 531.
Subjects will be assigned to a follow-up bone marrow biopsy and aspirate after either 9 months or 6 months of treatment. The subjects will be assigned to follow-up time in descending order, with the first 5 subjects from each study assigned to 9 month follow-up, and the last 5 subjects from each study assigned to 6 month follow-up. Some subjects will have their follow-up bone marrow biopsy and aspirate while on the open label extension study (20030213).
To eliminate the possibility of performing a bone marrow biopsy and aspirate on a placebo subject, all subjects who were assigned to a 6 month follow-up will be unblinded at the end of the phase 3 study treatment period (week 26). If the subject was on AMG 531, they must have their follow-up bone marrow biopsy and aspirate within one week (week 27). If the subject was on placebo, they will have their follow-up bone marrow performed after 3 months of treatment in the open label study.
The subjects that were assigned to a 9 month follow-up will have their platelet counts monitored as required by the phase 3 protocol. Any subject who has a platelet count > 50 x 109/L at week 26 of the phase 3 study, will be required to schedule a bone marrow biopsy and aspirate for week 27. If their platelet count is still > 50 x 109/L at week 27, they will have their bone marrow biopsy and aspirate at that time. If their platelet count drops to ≤ 50 x 109/L prior to week 27, they will have their follow-up bone marrow biopsy and aspirate performed after completing 3 months of treatment on the open label study (20030213).
Subjects who discontinue AMG 531 treatment will have the follow-up bone marrow biopsy and aspirate at the time of discontinuation, regardless of the pre-assigned date of the follow-up.
If a subject requires a bone marrow biopsy and aspirate as part of a safety assessment, this assessment will be counted as the follow-up bone marrow biopsy regardless of the timing of the assessment. Any additional clinically warranted bone marrow biopsies will also be sent to the central pathology lab for review.
All bone marrow biopsy reports will be provided by the central lab at the end of this study, but will not be available for clinical management at the time that the sample is collected.
All bone marrow biopsies will be evaluated by the central pathology lab.
Type d'étude
Inscription (Réel)
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Subjects must be enrolled in AMG 531 protocol 20030105 or 20030212
- Subject must have had a bone marrow biopsy within one year of enrollment (with available tissue block to send to a central pathology laboratory for interpretation) or must consent to a pre-treatment bone marrow biopsy and aspirate
- Written informed consent
Exclusion Criteria:
- Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
---|---|
Observed Subjects
Subjects that submitted bone marrow biopsy and aspirates.
|
No intervention was used on this protocol, as this was an observational study.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
The changes from baseline in bone marrow morphology by subject
Délai: Entire duration of the study
|
Entire duration of the study
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
The changes from baseline in bone marrow morphology by dose range
Délai: Entire duration of the study
|
Entire duration of the study
|
The changes from baseline in bone marrow morphology by length of treatment with AMG 531
Délai: Entire duration of the study
|
Entire duration of the study
|
The changes from baseline bone marrow morphology for splenectomized and non-splenectomized subjects
Délai: Entire duration of the study
|
Entire duration of the study
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Maladies du système immunitaire
- Maladies auto-immunes
- Maladies hématologiques
- Hémorragie
- Troubles hémorragiques
- Troubles de la coagulation sanguine
- Manifestations cutanées
- Thrombocytopénie
- Troubles des plaquettes sanguines
- Microangiopathies thrombotiques
- Purpura
- Purpura thrombocytopénique
- Purpura, thrombocytopénique, idiopathique
Autres numéros d'identification d'étude
- 20050123
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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