2025-521155-23-00招募中2 期
C5001004 - A Phase 2, Open-Label Extension Study to Investigate the Safety and Efficacy of PF-07868489 Administered to Adult Participants With Pulmonary Arterial Hypertension
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Pfizer Inc.
- 入组人数
- 5
- 试验地点
- 10
- 主要终点
- Incidence and severity of treatment emergent Adverse Events (AEs) and Serious Adverse Events (SAEs).
研究概览
简要总结
To evaluate the long-term safety and tolerability of repeat subcutaneous (SC) doses of PF-07868489 in participants with PAH.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older at screening of the qualifying (parent) study (or the minimum age of consent in accordance with local regulations), who have completed at least 20-week treatment period and week 24 study procedures of the qualifying study.
- •Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- •Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
排除标准
- •Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
- •Participants who met discontinuation criteria at any point during the participating qualifying C5001001 study.
- •Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
- •Participants with clinical worsening or hospitalization for worsening PAH during the qualifying study, placement on a transplant list, and planned surgical procedure for PAH.
- •Participants with an ongoing clinically significant safety event in the qualifying parent study (C5001001 Part B) based on CTCAE Grade 3 or higher (Grade 4 for PAH-related) or in the opinion of the investigator that would preclude treatment with open label PF-
- •History or currently established hepato-pulmonary syndrome.
- •Use of any prohibited concomitant medication(s) during the qualifying or current study or unwillingness or inability to use a required concomitant medication(s) or change in stable background PAH medications used in the qualifying study. Refer to Section 6.
- •Current use of GLP-1 agonist.
- •Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study.
- •Any of the following clinical chemistry values at baseline: ALT or AST > 3× ULN (> 5 ULN if solely due to right heart failure) or total bilirubin ≥2 × ULN (For Gilbert’s syndrome, direct bilirubin >ULN [or ≥ 2 × ULN if solely due to right heart failure] is exclusionary).
- •Poor compliance with study visits or procedures during the qualifying C5001001 study, as assessed by the investigator or the Pfizer Medical Monitor.
结局指标
主要结局
Incidence and severity of treatment emergent Adverse Events (AEs) and Serious Adverse Events (SAEs).
Incidence and severity of treatment emergent Adverse Events (AEs) and Serious Adverse Events (SAEs).
Incidence of related treatment emergent AEs (TEAEs) & treatment emergent SAEs (TESAEs).
Incidence of related treatment emergent AEs (TEAEs) & treatment emergent SAEs (TESAEs).
Change from baseline in vital signs.
Change from baseline in vital signs.
Change from baseline in clinical laboratory values.
Change from baseline in clinical laboratory values.
Change from baseline in electrocardiogram (ECG) parameters (heart rate, QT, QTc corrected using Fridericia’s formula (QTcF), PR, and QRS intervals).
Change from baseline in electrocardiogram (ECG) parameters (heart rate, QT, QTc corrected using Fridericia’s formula (QTcF), PR, and QRS intervals).
次要结局
- Change from baseline in NT-pro-BNP.
- PF-07868489 PK parameters after repeat doses; as data permit: minimum plasma concentration (Cmin).
- Incidence of the development of antidrug antibody (ADA) against PF-07868489 following repeat doses.
研究者
Clinical Medical Lead
Scientific
Pfizer Inc.
研究点 (10)
Loading locations...
相似试验
招募中
1 期
Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid TumorsColorectal CancerNon-Small Cell Lung CancerNCT07261631Novartis Pharmaceuticals180
招募中
1 期
KSV01 Injection for the Treatment of Relapsed/Refractory Diffuse Large B-Cell LymphomaDiffuse Large B Cell Lymphoma (DLBCL)NCT07260812TCRx Therapeutics Co.Ltd18
招募中
2 期
Gene Therapy for Crigler-Najjar Syndrome2023-507007-60-00Genethon17
招募中
3 期
A Study to Compare the Efficacy and Safety of Oral Azacitidine (Oral-Aza, ONUREG®) plus BSC versus Placebo plus BSC in Participants with IPSS-R Low- or Intermediate-risk MDS2022-500479-29-00Celgene Corp.166
招募中
1 期
A Phase I Study to Investigate the Safety and Tolerability of KGX101 Monotherapy and Combination Therapy With Envafolimab in Advanced or Metastatic Solid Tumor PatientsNCT07260305Kangabio AUSTRALIA LTD PTY57