A phase 3B, open-label, single-arm, rollover study to evaluate long-term safety in subjects who have participated in other Luspatercept (ACE-536) clinical trials. - Celgene - ACE-536-LTFU-001

Celgene Corporation0 个研究点目标入组 5 人开始时间: 待定最近更新: 2024年9月9日

适应症

试验速览

阶段: 3 期
状态: 招募中
发起方: Celgene Corporation
入组人数: 5

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 99（—）

入选标准

•1. Subject is >= 18 years at the time of signing the informed consent form (ICF).
•2. Subject is willing and able to adhere to the study visit schedule and other
•protocol requirements.
•3. Subject has been participating in a luspatercept trial and continues to
•fulfill all the requirements of the parent protocol and the subject has been
•a. Assigned to luspatercept treatment, continues to receive clinical benefit in
•the opinion of the investigator and should continue to receive luspatercept
•treatment, OR
•b. Assigned to placebo arm in the parent protocol (at the time of unblinding or
•in follow-up) and should cross over to luspatercept treatment, OR
•c. Assigned to the Follow-up Phase of the parent protocol, previously treated
•with luspatercept or placebo in the parent protocol who shall continue into
•Long-term Post-treatment Follow-up Phase in the rollover study until the
•follow-up commitments are met (unless requirements are met as per parent
•protocol to cross-over to luspatercept treatment).
•4. Subject understands and voluntarily signs an informed consent document prior
•to any study-related assessments or procedures being conducted.
•5. Subject demonstrates compliance, as assessed by the investigator, with the
•parent study protocol requirements.
•6. Applies to on treatment subjects only- females of childbearing potential
•(FCBP) defined as a sexually mature woman who:
•1) has achieved menarche at some point, 2) has not undergone a hysterectomy or
•bilateral oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea
•following cancer therapy or amenorrhea due to other medical reasons does not
•rule out childbearing potential) for at least 24 consecutive months (ie, has
•had menses at any time in the preceding 24 consecutive months) and must:
•a. Have two negative pregnancy tests as verified by the investigator prior to
•starting study therapy. A medically supervised serum pregnancy
•test (conducted locally) is to be obtained and verified negative in all female
•subjects of childbearing potential at enrollment (for details refer
•to Section 6.1.7). She must agree to ongoing pregnancy testing during the
•course of the study, and after end of study therapy. This applies even if the
•subject practices true abstinence* from heterosexual contact.
•b. Either commit to true abstinence* from heterosexual contact (which must be
•reviewed on a monthly basis and source documented) or agree to use, and be able
•to comply with highly effective, contraception without interruption, 35 days
•prior to starting investigational product (IP), during the study therapy
•(including dose interruptions), and for 84 days after discontinuation of study
•7. Applies to on treatment subjects only- Male subjects must:
•a. Agree to use a condom during sexual contact with a pregnant female or a
•female of childbearing potential while participating in the study, during dose
•interruptions and for at least 84 days following investigational product
•discontinuation even if he has undergone a successful vasectomy.
•* True abstinence is acceptable when this is in line with the preferred and
•usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation,
•symptothermal, post-ovulation methods] and withdrawal are not acceptable
•methods of contraception).

排除标准

•1. 1. Applies to on treatment subjects only- Concomitant use of any
•medications/procedures that are prohibited in the parent luspatercept protocol.
•2. Subject has met one or more criteria for study discontinuation as stipulated
•in the parent luspatercept protocol.
•3. Applies to on treatment subjects only- More than 26 days between last
•luspatercept dose in the parent protocol and first dose into ACE- 536LTFU-001
•protocol unless dose delay or dose discontinuation criteria
•4. Applies to on treatment subjects only- Pregnant or breastfeeding females. If
•breastfeeding, agree to stop breastfeeding prior to the participation in the
•study and not to resume breastfeeding during treatment with luspatercept and
•until 3 months after the last dose.
•5. Subject has any significant medical condition, laboratory abnormality,
•psychiatric illness, or is considered vulnerable by local regulations (eg,
•imprisoned or institutionalized) that would prevent the subject from
•participating in the study.
•6. Subject has any condition including the presence of laboratory
•abnormalities, which places the subject at unacceptable risk if he/she were to
•participate in the study.
•7. Subject has any condition that confounds the ability to interpret data from

研究者

发起方

Celgene Corporation

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