Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Christopher Barnett, MD
Headshot of Christopher Barnett
Christopher Barnett

Description

Summary

This study is being conducted to assess the long-term safety, tolerability, and efficacy of sotatercept in PAH.

Official Title

An Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH

Details

This Long-term Follow-up Study (LTFU) study is supported by data from the PULSAR study in which treatment with sotatercept resulted in hemodynamic and functional improvements in the study participants, including those receiving maximal PAH therapy with double/triple drug combinations and intravenous prostacyclin. The primary objective of this open-label, LTFU study is to evaluate the long-term safety and tolerability of sotatercept when added to background PAH therapy in adult subject with PAH who have completed prior sotatercept studies. The secondary objective is to evaluate continued efficacy in adult subject with PAH who have completed prior sotatercept studies. Participants eligible to enroll in the study will have participated in and completed the relevant study requirements of the parent PAH sotatercept clinical studies

Keywords

PAH sotatercept

Eligibility

You can join if…

Open to people ages 18 years and up

Eligible participants must meet the following criteria to be enrolled in the study:

  1. Participants must have completed their current respective PAH sotatercept clinical study and its requirements, and must not have discontinued early.
  2. Participants must be willing to adhere to the study visit schedule and understand and comply with all protocol requirements.
  3. Participants must have the ability to understand and provide written informed consent.
  4. Females of childbearing potential must:
  5. Have a negative pregnancy test as verified by the investigator prior to starting study drug administration; she must agree to ongoing pregnancy testing during the course of the study and until 8 weeks after the last dose of the study drug.
  6. If sexually active, have used, and agree to continue to use highly effective contraception without interruption, for at least 28 days prior to starting the investigational product, during the study (including dose interruptions), and for 16 weeks (112 days) after discontinuation of study drug.
  7. Refrain from breastfeeding a child or donating blood, eggs, or ovum for the duration of the study and for at least 16 weeks (112 days) after the last dose of study drug.

See Appendix 4 for additional contraceptive information.

  1. Male participants must:
  2. Agree to use a condom, defined as a male latex condom or non latex condom NOT made out of natural (animal) membrane (e.g., polyurethane), 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 16 weeks (112 days) following investigational product discontinuation, even if he has undergone a successful vasectomy.
  3. Refrain from donating blood or sperm for the duration of the study and for 16 weeks (112 days) after the last dose of study drug.
  4. Participants must agree not to participate in any other trials of investigational drugs/devices while they are enrolled in the A011-12 study.

You CAN'T join if...

Participants will be excluded from the study if any of the following criteria are met:

  1. Not enrolled in a PAH parent study at the time of enrollment.
  2. Missed more than the equivalent of 4 consecutive doses between the end of parent study and the start of this study.
  3. Presence of an ongoing serious adverse event that occurred during a PAH sotatercept clinical study that is assessed to be possibly or probably related to sotatercept.
  4. Pregnant or breastfeeding females.

Locations

  • UCSF Ambulatory Care Center accepting new patients
    San Francisco California 94117 United States
  • Arizona Pulmonary Specialists accepting new patients
    Phoenix Arizona 85012 United States
  • Pulmonary Associates P.A. accepting new patients
    Phoenix Arizona 85032 United States

Lead Scientist at UCSF

  • Christopher Barnett, MD
    Dr. Barnett is certified in critical care medicine, cardiology and advanced heart failure/pulmonary hypertension. The field of critical care cardiology is a new and emerging specialty in cardiology.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Acceleron Pharma Inc.
ID
NCT04796337
Phase
Phase 3 research study
Study Type
Interventional
Last Updated