Protocol
How many ICFs exist in the study?
Main ICF stage 1, Main ICF stage 2, Scout ICF where applicable
Name the portal where the ePatch data is uploaded.
MAESTRO
What paper safety forms exist for this trial?
SAE, Pregnancy reporting, Special situations.
How do you know if a subject agreed to participate in Concierge services?
Consent given in Main ICF by checking yes.
When should the first IMV occur in the study and when should the subsequent IMVs take place?
Within 14 days of the 1st randomization or within 4 weeks (+/- 2 weeks) of the 2nd SF , then every 12 – 14 weeks thereafter.
What key procedure must be completed prior to completion of any OLE study assessments?
Subject has to sign Stage 2 ICF.
Name the portal where ECHO data is uploaded.
Square
Within how many hours must Serious Breach be reported to the sponsor?
24 hours of awareness
How do you know if a site is participating in Scout?
This information is located in the site's CTA & ICFs.
What is the CRA’s responsibility if deviations occur at a site?
Ensure the protocol deviation is appropriately documented and preform retraining of the site to prevent future occurrences.
What is the primary efficacy endpoint in the study?
Change from baseline to week 25 6-minute walk distance.
What is Judi & its purpose for this trial?
JUDI is the system where clinical worsening events will be transferred from EDC to be reviewed and adjudicated by the CEC. CWE includes deaths, hospitalization, and worsening of PH-HF-pEF outpatient setting as defined in the LEVEL-2 protocol.
When should a site submit the PEF in Firecrest?
Sites should submit the PEF when all screening assessment results have been received, the site has confirmed the eligibility criteria, & the subject is ready for Day 1. The PEF is reviewed by MM team, before Day 1 is to be completed. [AP1] Form to be completed no later than 5 business days prior to planned randomization.
For the LEVEL-2 trial what is the difference between the services provided by ICON Concierge Services and Scout?
Both are optional services the sites can opt to utilize. ICON Concierge Services provides direct-to-patient contacts to boost retention of participants. Concierge Services will welcome patients to the study, review study tasks via phone call, check-in during the study, provide patient reminders to wear ePatch at specified visits. Scout provides travel management and reimbursement services.
Can patients with a diagnosis of PH WHO Groups 1, 3, 4, or 5 be included in the study?
No, group 2 only.
True or False: My site has performed the 6 MWT on another trial so training is not required.
False. LEVEL-2 6 MWT training in Firecrest is required.
What is MAPI?
Vendor of patient questionnaires (PGIC, PGIS, KCCQ)
Within how many hours must Clinical Worsening Events be reported to the sponsor?
72 hours
True/False: The genotyping sample is collected for all patients.
False, only those that agree to it.
Can a patient with available documentation of pulmonary thromboembolism in the last 12 months be randomized?
No, exclusion 8.
RHC was performed outside the allowed window (120 Days), but values meet criteria. Is enrollment allowed?
No - RHC is to be repeated during screening window.
What is required for ICON Concierge Services to be initiated?
Subject agrees to participate, the site completes the subject contact form, the form is sent to CS.
From what timepoints are SAEs collected?
From ICF to EOS/30 days after IP.
Does the OLE period indicate the TNX-103-08 study?
no, the OLE period is part of the TNX-103-07. The 08 study is a separate protocol.
What is the dosage of IP between Day 1 and Week 3 in Double Blind period? And what is the dosage in OLE during same period?
1mg BID
What hemodynamic assessment confirms Group 2 PH-HFpEF in the study?
RHC
Name the system that houses site training and site tools?
Firecrest
True/False: Before randomization of EACH patient, Sponsor/ MM will confirm patient's eligibility?
True, using PEF.
CTL provides medical background to the project to support PI training & boost recruitment. Responsible for the Site Specific Recruitment Plan.
Study has reached 150 subjects with 52 weeks of DB IP. My site has a patient who is at Week 39. When do they need to complete Week 52 visit to start OLE?
10 days after notification.