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โ† Trials
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A Trial of "APL-9796'' in Adults With Pulmonary Hypertension

RecruitingPhase 2Ages 18 Years - 80 YearsAllApollo Therapeutics Ltd
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In plain words

What the trial is, and whether it could suit you

The AP13CP02 study is a phase 2, open-label, dose escalation trial to determine how safe and tolerable multiple subcutaneous (SC) injections of APL-9796 are for patients with PH. The study will also assess how effective APL-9796 could be for treating patients with PH and whether the body produces antibodies working against APL-9796. The trial will be conducted in two parts: * Part A: Up to 36 adults with WHO Group 1 Pulmonary arterial hypertension (PAH). * Part B (optional): Up to 12 adults with WHO Group 3 - PH associated with ILD (PH-ILD).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Participant must be 18 to 80 years of age inclusive 2. Participants who are diagnosed with pulmonary hypertension via right heart catheterisation (RHC), documented at any time prior to Screening. 3. WHO Functional Class II or III 4. Participant has the CardioMEMS PA Sensor implanted. Exclusion Criteria: 1. Hospital admission related to PH within 3 months prior to Screening. 2. Major surgical procedure within 3 months prior to Screening, unless participant is assessed as completely recovered by the Investigator 3. Diagnosis of PH due to human immunodeficiency virus, portal hypertension, schistosomiasis, or uncorrected congenital heart disease 4. History of left-sided heart disease and/or clinically significant cardiac disease 5. History of uncontrolled systemic hypertension 6. eGFR โ‰ค30 ml/min/1.73m2 7. Life expectancy of \< 12 months, as assessed by the Investigator 8. Diagnosed with a malignancy within 5 years of enrolment 9. Contraindications to protocol-required imaging (MRI), diagnostic, or sampling methods
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What it tests

  • APL-9796
  • APL-9796
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Where

6 sites
Hammersmith/Imperial Hospital
London, United Kingdom
Royal United Hospital Bath
Bath, United Kingdom
Royal Papworth Hospital
Cambridge, United Kingdom
Golden Jubilee Hospital
Clydebank, United Kingdom
Royal Brompton Hospital
London, United Kingdom
Sheffield Teaching Hospitals
Sheffield, United Kingdom
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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