Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02279173 · ClinicalTrials.gov registry record · Phase 3
Long-term Study of Romiplostim in Thrombocytopenic Pediatric Patients With Immune Thrombocytopenia (ITP)
A Phase 3 study of Immune Thrombocytopenia, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 203
- Enrollment target
- 20
- Study locations
NCT02279173: Completed Phase 3 study of Immune Thrombocytopenia, sponsored by Amgen.
NCT02279173 is a Phase 3 study of Immune Thrombocytopenia that has completed, run by Amgen. The registered enrollment target is 203 participants, above the 90-participant average among 6 other Immune Thrombocytopenia trials with a reported enrollment target (126% higher). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02279173, a Phase 3 study of Immune Thrombocytopenia, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 203 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a phase 3b single arm, open label, multicenter study describing the percentage of time pediatric participants with ITP have a platelet response while receiving romiplostim, defined as a platelet count ≥ 50 x 10\^9/L in the absence of ITP rescue medications for the past 4 weeks.
Primary Outcome
Platelet response was defined as a platelet count of ≥ 50 x 10⁹/L with no rescue medication use for ITP in the past 4 weeks. Monthly platelet response was calculated based on the median platelet count during each month. For each participant, the percentage of time with platelet response during the first 6 months was calculated as the number of months a platelet response was observed divided by the total number of months response was assessed.
Conditions Studied
Interventions
- DRUG Romiplostim
Study Locations (20)
Texas
- Research Site - Dallas
- Research Site - Fort Worth
- Research Site - Houston
Illinois
- Research Site - Chicago
- Research Site - Peoria
Ohio
- Research Site - Cincinnati
- Research Site - Columbus
California
- Research Site - Roseville
Georgia
- Research Site - Atlanta
Indiana
- Research Site - Indianapolis
Iowa
- Research Site - Iowa City
Missouri
- Research Site - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 203 participants |
| Start Date | 2014-12-10 |
| Est. Completion | 2019-08-08 |
| Phase | Phase 3 |
What the finished NCT02279173 record still lists
NCT02279173 is an interventional study that assigns participants to a tested intervention. The registered 203 participants enrollment target is mid-sized for trials with a published cap, above the 90-participant average among 6 other Immune Thrombocytopenia trials with a reported enrollment target (126% higher).
The record links to 1 condition, with Immune Thrombocytopenia appearing as the primary indexed condition, and to 1 intervention - of which Romiplostim is the first listed.
NCT02279173 names 20 study sites across 16 states, led by Texas, Illinois, Ohio.
Frequently Asked Questions
What is clinical trial NCT02279173 about?
NCT02279173 is a clinical study titled "Long-term Study of Romiplostim in Thrombocytopenic Pediatric Patients With Immune Thrombocytopenia (ITP)". This is a phase 3b single arm, open label, multicenter study describing the percentage of time pediatric participants with ITP have a platelet response while receiving romiplostim, defined as a platelet count ≥ 50 x 10\^9/L in the absence of ITP rescue medications for the past 4 weeks.
What is the current status of trial NCT02279173?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 203 participants. The study started on 2014-12-10. Estimated completion is 2019-08-08.
What conditions does trial NCT02279173 study?
This clinical trial studies the following conditions: Immune Thrombocytopenia.
What interventions are being tested in trial NCT02279173?
The interventions under investigation include: Romiplostim (DRUG).
Who is sponsoring clinical trial NCT02279173?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02279173 being conducted?
This trial has 20 study locations across California, Georgia, Illinois, Indiana, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Immune Thrombocytopenia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment
RECRUITING · Phase 3
-
Study to Evaluate Rilzabrutinib in Adults and Adolescents With Persistent or Chronic Immune Thrombocytopenia (ITP)
ACTIVE NOT RECRUITING · Phase 3
-
Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders
RECRUITING · Phase 2
-
Cognitive Dysfunction in Chronic and Persistent Immune Thrombocytopenia
RECRUITING
-
An Open-label Study of Povetacicept in Participants With Autoimmune Cytopenias
ACTIVE NOT RECRUITING · Phase 1
-
Safety and Treatment Satisfaction in Adults With Chronic ITP After Switching to Avatrombopag From Eltrombopag or Romiplostim
COMPLETED · Phase 4
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05652686 · 203 participants · Phase 1
A Study of Peluntamig (PT217) in Patients With Neuroendocrine Carcinomas Expressing DLL3 (the SKYBRIDGE Study)
- NCT06063122 · 203 participants · NA
Development of a Therapeutic Device to Improve Speech Sound Differentiation in Preterm Infants
- NCT07031245 · 203 participants · NA
Evidence-Based Quality Improvement to Reduce VA Primary Care Burnout
- NCT03481010 · 204 participants · NA
Periacetabular Osteotomy With and Without Arthroscopic Management of Central Compartment Pathology
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI