GBT2104-133
- Conditions
- Haematological DisordersSickle Cell Disease
- Registration Number
- PACTR202108532761448
- Lead Sponsor
- Global Blood Therapeutics Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 520
Inclusion Criteria Participants who meet all the following criteria will be eligible for study enrollment:
1. Male or female participant with SCD who participated and received study drug in a GBT-Sponsored inclacumab clinical study.
2. Participant has completed the originating inclacumab study within 30 days prior to the Day 1 Visit. Participants who discontinued study drug in the originating study due to a non-study drug-related adverse event (AE), but who remained on study, may be eligible for treatment in this study provided the AE does not pose a risk for treatment with inclacumab.
3. Female participants of childbearing potential are required to have a negative urine pregnancy test prior to dosing on Day 1. Note: Female participants who become childbearing during the study must be willing to have a negative urine pregnancy test to remain in the study.
4. If sexually active, female participants of childbearing potential must use highly effective methods of contraception until 165 days after the last dose of study drug. If sexually active, male participants must use barrier methods of contraception until 165 days after the last dose of study drug.
5. Participant has provided written informed consent/assent. For underage participants, both the consent of the participant’s legal representative or legal guardian and the participant’s assent (where applicable) must be obtained based on local requirement.
Exclusion Criteria Participants meeting any of the following exclusion criteria will not be eligible for study enrollment:
1. Female participant who is breastfeeding or pregnant.
2. Participant had an infusion-related reaction (IRR) in the originating inclacumab clinical study.
3. Participant withdrew consent from the originating inclacumab clinical study.
4. Participant was lost to follow-up from the originating inclacumab clinical study.
5. Participant has any medical, psychological, safety, or behavioral conditions that, in the opinion of the Investigator, may confound safety interpretation, interfere with compliance, or preclude informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study is to evaluate the long-term safety of every 12-week dosing of inclacumab in participants with SCD that have completed a prior inclacumab clinical trial.<br>
- Secondary Outcome Measures
Name Time Method Additional objectives are to evaluate the incidence of VOCs, hospitalizations, missed work/school days, RBC transfusions, and quality of life (QoL) with long-term use of inclacumab.