An Open-Label Extension Study for Participants with PAH Who Have Previously Participated in a Clinical Trial with PF-07868489
Key facts
- Where
- Dresden, Giessen, Greifswald, Heidelberg és Regensburg, NémetországSee the 5 sites
- Phase
- 2. fázis
Where in Németország
- Technische Universitaet DresdenDresden, NémetországNo longer taking part
- Universitaetsklinikum Giessen und Marburg GmbHGiessen, NémetországNo longer taking part
- Universitaetsmedizin Greifswald KöRGreifswald, NémetországNo longer taking part
- Thoraxklinik Heidelberg gGmbHHeidelberg, NémetországNo longer taking part
- Universitaetsklinikum Regensburg AöRRegensburg, NémetországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Pfizer Inc.
- Trial code
- EU 2025-521155-23-00
- Record updated
- 2026. augusztus 25.
- Original description
To evaluate the long-term safety and tolerability of repeat subcutaneous (SC) doses of PF-07868489 in participants with PAH.Read full original descriptionShow less
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
To evaluate the long-term safety and tolerability of repeat subcutaneous (SC) doses of PF-07868489 in participants with PAH.
Inclusion: 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.
Exclusion: 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-07868489; 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 6.9; Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study; History or currently established hepato-pulmonary syndrome; 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; 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); 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; Current use of GLP-1 agonist; Poor compliance with study visits or procedures during the qualifying C5001001 study, as assessed by the investigator or the Pfizer Medical Monitor.