EUCTR2021-001427-40-FR进行中（未招募）1 期
An Open-Label, Extension Study to Assess the Long-Term Safety and Efficacy of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 165
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
- 性别
- All
入选标准
- •1. Satisfactory completion of ION-682884-CS3 as judged by the Investigator and Sponsor, OR diagnosis of hATTR-PN and satisfactory completion of either study ISIS 420915-CS101 or study 2018-P001436 (both are Investigator-Sponsored studies with inotersen - the unconjugated version of ION-682884) as judged by the Investigator and Sponsor
- •2. Must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements
- •3. Satisfy the following:
- •a. Females: must be non-pregnant and non-lactating and either:
- •- Surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy)
- •- Post-menopausal (defined as 12 months of spontaneous amenorrhea in females > 55 years of age or, in females = 55 years, 12 months of spontaneous amenorrhea without an alternative medical cause and FSH levels in the postmenopausal range for the laboratory involved)
- •- Abstinent*or
- •- If engaged in sexual relations of child-bearing potential, agree to use highly effective contraceptive methods (Section 6.4.1) from the time of signing the informed consent form until at least 24 weeks after the last dose of ION-682884 and agree to receive pregnancy tests per protocol
- •b. Males: Surgically sterile (i.e., bilateral orchidectomy) or abstinent*, if engaged in sexual relations with a woman of child-bearing potential (WOCBP), the patient’s non-pregnant female partner must use a highly effective contraceptive method (Section 6.4.1) from the time of signing the informed consent form until at least 24 weeks after the last dose of ION-682884 *Abstinence (i.e., refraining from heterosexual intercourse throughout the duration of study participation) is only acceptable as true abstinence, i.e., when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of a trial and withdrawal are not acceptable methods of contraception.
- •4. Willingness to adhere to vitamin A supplementation per protocol
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 116
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 52
排除标准
- •1. Have any new condition or worsening of existing condition that in the opinion of the Investigator or Sponsor would make the patient unsuitable for enrollment, or could interfere with the patient participating in or completing the study.
研究者
相似试验
进行中（未招募）
1 期
Study to Assess the Long-Term Safety and Efficacy of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid PolyneuropathyHereditary Transthyretin-Mediated Amyloid PolyneuropathyMedDRA version: 20.0Level: LLTClassification code 10057949Term: Familial amyloid polyneuropathySystem Organ Class: 100000004850EUCTR2021-001427-40-CYIonis Pharmaceuticals, Inc.165
进行中（未招募）
1 期
Study to Assess the Long-Term Safety and Efficacy of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid PolyneuropathyHereditary Transthyretin-Mediated Amyloid PolyneuropathyMedDRA version: 20.0Level: LLTClassification code 10057949Term: Familial amyloid polyneuropathySystem Organ Class: 100000004850EUCTR2021-001427-40-ESIonis Pharmaceuticals, Inc.165
进行中（未招募）
1 期
Study to Assess the Long-Term Safety and Efficacy of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid PolyneuropathyHereditary Transthyretin-Mediated Amyloid PolyneuropathyMedDRA version: 20.0Level: LLTClassification code 10057949Term: Familial amyloid polyneuropathySystem Organ Class: 100000004850EUCTR2021-001427-40-SEIonis Pharmaceuticals, Inc.165
进行中（未招募）
1 期
Study to Assess the Long-Term Safety and Efficacy of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid PolyneuropathyHereditary Transthyretin-Mediated Amyloid PolyneuropathyMedDRA version: 20.0Level: LLTClassification code 10057949Term: Familial amyloid polyneuropathySystem Organ Class: 100000004850EUCTR2021-001427-40-PTIonis Pharmaceuticals, Inc.165
进行中（未招募）
1 期
Study of the safety of the long-acting opioid pain medication Oxycodone hydrochloride in children who have been treated previously with opioid pain medication who completed the OTR3001 studyOpioid experienced paediatric patients aged 6-17 years with moderate to severe malignant and/or nonmalignant pain requiring opioid therapy.MedDRA version: 14.0Level: LLTClassification code 10002182Term: AnalgesiaSystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2011-002235-26-SKPurdue Pharma L.P.135