Not yet recruiting NCT07632898
Open-Label Study of IKT-001 in Pulmonary Arterial Hypertension (PAH)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IKT-001.
- Who it may be relevant to
- Registry conditions: Pulmonary Arterial Hypertension (PAH). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Open-Label, Long-Term Extension Study to Evaluate the Safety and Tolerability of IKT-001 in Pulmonary Arterial Hypertension
Overview
This is a multicenter, open-label extension (OLE), single-arm study designed to assess the long-term safety and tolerability of oral IKT-001 administered once daily.
Interventions
- Drug IKT-001
IKT-001 tablets for PO administration
Primary outcome measures
- Incidence of Treatment-emergent adverse events (TEAEs), serious TEAEs, and TEAEs of special interest [Time frame: From baseline to end of study (up to 2 years or availability of commercial product)]
Secondary outcome measures (2)
- Change from baseline in 6-minute walk distance (6MWD) [Time frame: From baseline to end of study (up to 2 years or availability of commercial product)]
- Change from baseline in NT-proBNP [Time frame: From baseline to end of study (up to 2 years or availability of commercial product)]
Eligibility criteria
Inclusion criteria
- Capable of giving signed informed consent.
- Participants who have completed Study IKT-001-201 or any other Phase 2 or 3 controlled clinical study with IKT-001.
Exclusion criteria
- Any of the following clinical laboratory values at screening:
- ALT or AST levels >3× the ULN
- Bilirubin levels >2× the ULN
- ANC <1.2 ×10\^9 cells/L, hemoglobin <9 g/dL, hematocrit <30%, or platelets <75 × 10\^9 cells/L
- Absolute eGFR <30 mL/min using creatinine or cystatin C as defined by the CKD-EPI equation (2021)
- Currently lactating, pregnant or planning on becoming pregnant during the study.
- Receiving treatment with sotatercept.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07632898 · IKT-001-202