A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study
- Conditions
- Non-Hodgekin10025320
- Registration Number
- NL-OMON43124
- Lead Sponsor
- Janssen-Cilag
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1
- Participants must be currently participating in a PCI-32765 clinical study considered completed and have received at least 6 months of treatment with PCI-32765. At study entry, participants must be actively receiving treatment with single-agent PCI-32765;OR;- Subjects must have participated in a PCI-32765 randomized clinical study in which they initially received comparator treatment and now cross-over to ibrutinib. Note: A minimum of 6 months requirement for prior PCI-32765 treatment will not be mandatory in this case and subjects with less than 6 months will be required to have more frequent initial safety assessments (see Time and Events Table 2);- Agrees to protocol-defined use of effective contraception;- Negative blood or urine pregnancy test at screening
- Requires anticoagulation with warfarin or equivalent vitamin K antagonists;- Requires treatment with strong cytochrome P450 (CYP)3A4/5 inhibitors, unless previously approved by sponsor;- Any condition or situation which, in the opinion of the investigator, may put the participant at significant risk, may confound the study results, or may interfere significantly with volunteer*s participation in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The objective of this study is to collect long-term safety and efficacy data<br /><br>for subjects treated with PCI-32765 and to provide ongoing access to PCI-32765<br /><br>for subjects who are currently enrolled in PCI-32765 studies that have been<br /><br>completed according to the parent protocol (eg, final analysis has been<br /><br>performed), are actively receiving treatment with PCI-32765, and who continue<br /><br>to benefit from PCI-32765 treatment.</p><br>
- Secondary Outcome Measures
Name Time Method <p>not applicable</p><br>