EUCTR2021-006864-25-GR进行中（未招募）1 期
IMPAHCT-FUL: A Long-Term Extension, Multi-Center Safety Study of AV-101 in Subjects With Pulmonary Arterial Hypertension (PAH) Who Have Completed Study AV-101-002 - IMPAHCT-F
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 462
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
- •Key Inclusion Criteria: (Additional criteria, may apply, per the protocol)
- •To be eligible, a participant is required to be or have:
- •Consented to participate in the LTE and has successfully completed the placebo-controlled 24-week Study AV-101-002.
- •Female subjects of childbearing potential who have agreed to continue to use a highly effective form of contraception during the LTE and for at least 30 days after completing or discontinuing study treatment (highly effective forms of contraception).
- •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 323
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 139
排除标准
- •Key Exclusion Criteria:
- •Subjects meeting any of the following criteria:
- •The Investigator believes that it would not be in the best interest of the subject to be included in the LTE e.g., for clinical or social reasons.
- •Subjects who were not compliant with study medication in AV-101-002 as assessed by the Investigator
研究者
相似试验
进行中（未招募）
1 期
Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial – Follow Up Long Term Extension (IMPAHCT-FUL)Pulmonary Arterial Hypertension (PAH)MedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 20.0Level: LLTClassification code 10077729Term: Pulmonary arterial hypertension WHO functional class IIISystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 20.0Level: LLTClassification code 10077730Term: Pulmonary arterial hypertension WHO functional class IVSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 20.0Level: LLTClassification code 10077740Term: Pulmonary arterial hypertension WHO functional class IISystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2021-006864-25-IEAerovate Therapeutics, Inc.462
进行中（未招募）
1 期
Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial – Follow Up Long Term Extension (IMPAHCT-FUL)EUCTR2021-006864-25-DEAerovate Therapeutics, Inc.462
进行中（未招募）
1 期
Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial – Follow Up Long Term Extension (IMPAHCT-FUL)Pulmonary Arterial Hypertension (PAH)MedDRA version: 20.0Level: LLTClassification code: 10077740Term: Pulmonary arterial hypertension WHO functional class II Class: 10038738MedDRA version: 20.0Level: LLTClassification code: 10077730Term: Pulmonary arterial hypertension WHO functional class IV Class: 10038738MedDRA version: 21.1Level: PTClassification code: 10064911Term: Pulmonary arterial hypertension Class: 100000004855MedDRA version: 20.0Level: LLTClassification code: 10077729Term: Pulmonary arterial hypertension WHO functional class III Class: 10038738CTIS2023-508735-31-00Aerovate Therapeutics Inc.462
尚未招募
3 期
IMPAHCT-FUL: A Long-Term Extension, Multi-Center Safety Study of AV-101 in Subjects With Pulmonary Arterial Hypertension (PAH) Who Have Completed Study AV-101-002Pulmonary Arterial HypertensionPulmonary Arterial Hypertension (PAH)NL-OMON53603Aerovate Therapeutics, Inc9
进行中（未招募）
1 期
Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial – Follow Up Long Term Extension (IMPAHCT-FUL)Pulmonary Arterial Hypertension (PAH)MedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 20.0Level: LLTClassification code 10077729Term: Pulmonary arterial hypertension WHO functional class IIISystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 20.0Level: LLTClassification code 10077730Term: Pulmonary arterial hypertension WHO functional class IVSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 20.0Level: LLTClassification code 10077740Term: Pulmonary arterial hypertension WHO functional class IISystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2021-006864-25-NLAerovate Therapeutics, Inc.462