WHO ICTRP trial
A Long-term Extension Study of PCI-32765 (Ibrutinib)
EUCTR2012-004225-24-GB · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2012-004225-24-GB |
|---|---|
| Public title | A Long-term Extension Study of PCI-32765 (Ibrutinib) |
| Scientific title | A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study |
| Primary sponsor | Janssen-Cilag International NV |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | Portugal;United States;Taiwan;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Italy;France;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Czech… |
| Conditions | chronic lymphocytic leukemia/small lymphocytic lymphoma, mantle cell lymphoma, follicular lymphoma, and diffuse large B-cell lymphoma MedDRA version: 21.0 Level: LLT Classification code 10008976 Term: Chronic lymphocytic leukemia System… |
| Interventions | Trade Name: IMBRUVICA® Product Name: Ibrutinib Product Code: JNJ-54179060 Pharmaceutical Form: Capsule INN or Proposed INN: Ibrutinib CAS Number: 936563-96-1 Current Sponsor code: JNJ-54179060 Concentration unit: mg milligram(s)… |
| Registration date | Nov 28, 2012 |
| Target size | 700 |
| Secondary IDs | PCI-32765CAN3001 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: