Long-term Safety and Tolerability of TAK-881 in Subjects With Primary Immunodeficiency Diseases (PIDD)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 53
- 试验地点
- 29
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
The main aim of this study is to learn if TAK-881 is safe and well tolerated during long-term use in adults and children with PIDD who are eligible and completed study TAK-881-3001 (NCT05755035).
The participants will receive the first dose of TAK-881 immunoglobulin (IgG) infusion at the same dosage as the last dose administered in study TAK-881-3001 (NCT05755035). After the first TAK-881 infusion in study TAK-881-3002, the dosing interval (can be adjusted by participant/caregiver) and/or the dose of TAK-881 can be adjusted by the study doctor to every 2, 3 or 4 weeks at scheduled site visits.
Participants will visit the clinic every 12 weeks until the End of Study (EOS) visit.
详细描述
The study consists of two Epochs: Epoch 1 and Epoch 2. In Epoch 1 eligible participants will have the opportunity to receive TAK-881 for a minimum of 6 months. After 6 months in study TAK-881-3002, the results of the anti-rHuPH20 binding antibody assay from either study TAK-881-3001 (NCT05755035) or study TAK-881-3002 (Epoch 1) will be used to determine the next steps in the study:
- Epoch 1: Participants with an anti-rHuPH20 antibody titer less than [<] 1:160 will complete the EOS visit on the day of the first non-investigational product (IP) infusion following Study Visit Week 25.
- Epoch 2: Participants with an anti-rHuPH20 antibody titer greater than or equal to [>=] 1:160 at any time point during Study TAK-881-3001 (NCT05755035) and/or study TAK-881-3002 (Epoch 1), will continue with an additional two years of TAK-881 treatment and undergo safety follow-up and will complete the EOS visit on the day of the first non-IP infusion following study Visit Week 121.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who meet ALL of the following criteria are eligible for this study:
- •Participant must have completed Study TAK-881-3001 (NCT05755035).
- •Participant or, in the case of minors, legally designated representative(s) is/are willing and able to comply with the requirements of the protocol.
- •Participant or, in the case of minors, legally designated representative(s) has/have provided informed consent/assent (if applicable), including providing consent for use of the investigational medical device (in US sites only), prior to the initiation of any study procedures.
排除标准
- •Participant has a serious medical condition such that the participant's safety or medical care would be impacted by participation in this long-term follow-up study.
- •New medical condition that developed during participation in Study TAK-881-3001 (NCT05755035), that, in the judgment of the investigator, could increase risk to the participant or interfere with the evaluation of TAK-881 and/or conduct of the study.
- •Participant was enrolled in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to screening (with the exception of Study TAK-881-3001 [NCT05755035]).
- •Participant is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study.
- •Participant is a family member or employee of the investigator or the investigator's site staff.
- •Participants with potential to become pregnant who meet any one of the following criteria:-
- •Participant has a positive pregnancy test.
- •Participant does not agree to employ a highly effective form of contraception for the duration of the study.
- •If participant is pregnant or lactating at the time of screening or intends to become pregnant or begin lactating during the study.
研究组 & 干预措施
TAK-881
Epoch 1: Participants who completed study TAK-881-3001 (NCT05755035) and met eligibility criteria will receive TAK-881 using Koru 24 G HlgH Flo subcutaneous (SC) safety needle set (investigational in the US) at the same dose and same treatment interval as at the last infusion in TAK-881-3001 (NCT05755035) at Week 1 and at Weeks 13 and Week 25 of study TAK-881-3002.
Epoch 2: Participants with anti-rHuPH20 antibody titer >=1:160 at any time point during Study TAK-881-3001 (NCT05755035) and/or Study TAK-881-3002 Epoch 1, will continue receiving TAK-881 every 12 weeks for up to Week 121.
After the first TAK-881 infusion in study TAK-881-3002, the interval and/or the dose may be adjusted only at scheduled site visits at the investigator's discretion.
干预措施: Koru 24 G HIgH Flo Subcutaneous Safety Needle Set (investigational in the US) (Device)
TAK-881
Epoch 1: Participants who completed study TAK-881-3001 (NCT05755035) and met eligibility criteria will receive TAK-881 using Koru 24 G HlgH Flo subcutaneous (SC) safety needle set (investigational in the US) at the same dose and same treatment interval as at the last infusion in TAK-881-3001 (NCT05755035) at Week 1 and at Weeks 13 and Week 25 of study TAK-881-3002.
Epoch 2: Participants with anti-rHuPH20 antibody titer >=1:160 at any time point during Study TAK-881-3001 (NCT05755035) and/or Study TAK-881-3002 Epoch 1, will continue receiving TAK-881 every 12 weeks for up to Week 121.
After the first TAK-881 infusion in study TAK-881-3002, the interval and/or the dose may be adjusted only at scheduled site visits at the investigator's discretion.
干预措施: TAK-881 (Biological)
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
时间窗: Up to Week 121
Number of Participants With Infusion Withdrawals, Interruptions, and Infusion Rate Reductions due to TAK-881-related TEAEs
时间窗: Up to Week 121
次要结局
- Doses of TAK-881(Up to Week 121)
- Treatment Interval of TAK-881(Up to Week 121)
- Trough Level of Total IgG(Up to Week 121)
- Monthly Infusion Time (minutes/month) With Investigational Medical Device Using TAK-881(Up to Week 121)
- Number of Infusions Per Month With Investigational Medical Device Using TAK-881(Up to Week 121)
- Number of Infusions Sites (Needle Sticks) per Month With Investigational Medical Device Using TAK-881(Up to Week 121)
- Number of Acute Physician Visits Due to Infection or Other Illnesses(Up to Week 121)
- Time to First ASBI(Up to Week 121)
- Duration of Infections(Up to Week 121)
- Number of Infusions Sites (Needle Sticks) per infusion With Investigational Medical Device Using TAK-881(Up to Week 121)
- Infusion Volume per Site (milliliter/site) With Investigational Medical Device Using TAK-881(Up to Week 121)
- Treatment Preference Measured by a Disease-specific Questionnaire for Participants and the Investigational Medical Device Using TAK-881 in Participants Aged >=12 Years(At Weeks 25 and 73)
- Number of Participants With Adverse Events (AEs) Related to the Investigational Medical Device(Up to Week 121)
- Annualized Rate of Acute Serious Bacterial Infections (ASBIs)(Up to Week 121)
- Duration of Infusions (minutes) With Investigational Medical Device Using TAK-881(Up to Week 121)
- Maximum Tolerated Infusion Rate per Site (milliliter/hour/site) With Investigational Medical Device Using TAK-881(Up to Week 121)
- Infusion Preparation Time For TAK-881 by Participants/Caregiver(Up to Week 121)
- Annualized Rate of all Infections(Up to Week 121)
- Annualized Rate of Episodes of Fever(Up to Week 121)
- Number of Participants With Positive Binding Antibodies and Neutralizing Antibodies to rHuPH20(Up to Week 121)
- Health-Related Quality of Life (HRQoL): EuroQol 5 Dimension 5 Level Questionnaire (EQ-5D-5L) Score in Participants Aged >=12 Years(From Baseline up to Week 121)
- Number of Hospitalizations With Indications (Infection or other Illnesses)(Up to Week 121)
- Number of Days of Hospitalization(Up to Week 121)
- Number of Participants who have Infusions of TAK-881 at Physical Location(Up to Week 121)
- Number of Participants, Caregiver, or Healthcare Professional (HCP) who have Administration of TAK-881(Up to Week 121)
- Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores in Participants Aged >=16 Years(From Week 13 up to Week 121)
- Number of Days not Able to go to School, Work, Daycare, or to Perform Normal Daily Activities Due to Infections and/or their Treatment or Other Illnesses(Up to Week 121)
- Number of Days on Antibiotics(Up to Week 121)
- Infusion Preparation Time For TAK-881 by HCP(Up to Week 121)
- Infusion Volume per Site (milliliter/site) With TAK-881(Up to Week 121)
- Number of Infusions Per Month With TAK-881(Up to Week 121)
- Number of Infusions Sites (Needle Sticks) per Month With TAK-881(Up to Week 121)
- Number of Infusions Sites (Needle Sticks) per infusion With TAK-881(Up to Week 121)
- Duration of Infusions (minutes) With TAK-881(Up to Week 121)
- Monthly Infusion Time (minutes/month) With TAK-881(Up to Week 121)
- Maximum Tolerated Infusion Rate per Site (milliliter/hour/site) With TAK-881(Up to Week 121)
- Treatment Preference Measured by a Disease-specific Questionnaire for TAK-881 in Participants Aged >=12 Years(At Weeks 25 and 73)