Last updated 24 days ago

A Long-term Follow-up Study of Sotatercept for PAH Treatment (MK-7962-004/A011-12)

700 patients around the world

Available in Brazil, Colombia, Argentina, Mexico

Participants eligible to enroll in the study will have participated in and completed the relevant study requirements of the parent PAH sotatercept clinical studies.

Acceleron Pharma Inc.

700Patients around the world

This study is for people with

Pulmonary hypertension

Pulmonary arterial hypertension

Requirements for the patient

From 18 Years

All Gender

Medical requirements

: Have completed their current respective PAH sotatercept clinical study and its requirements, and must not have discontinued early
Must be willing to adhere to the study visit schedule and understand and comply with all protocol requirements
Must have the ability to understand and provide documented informed consent
Females of childbearing potential must:
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
If sexually active, have used, and agree to continue to use highly effective contraception in combination with a barrier method 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
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
Male participants must:
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
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
Must agree not to participate in any other trials of investigational drugs/devices while they are enrolled in the MK-7962-004 study

: Did not participate in a sotatercept PAH parent trial
Missed more than the equivalent of 4 consecutive doses between the end of parent study and the start of this study.
Presence of an ongoing serious adverse event (SAE) that occurred during a PAH sotatercept clinical study that is assessed to be possibly or probably related to sotatercept
Pregnant or breastfeeding females

StudySOTERIA

SponsorAcceleron Pharma Inc.

Study typeInterventional

Conditions

Pulmonary arterial hypertension

Requirements

From 18 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT04796337