Phase 3 Study on ABP 959 and PNH

What is the main condition being studied in the trial?

Which drug is being compared to ABP 959 in this study?

What type of study design is used in this trial?

How many participants were enrolled in the study?

What is the phase of the study?

What was the actual start date of the study?

How many locations were involved in this study?

When was the primary completion of the study?

Which of the following is an inclusion criterion for participation in the study?

What is the minimum age requirement for participants in the clinical study?

Which condition would exclude someone from participating in the study?

What specific vaccination must participants have received?

What is the specified administration period for eculizumab for participants in the study?

Which of the following cardiovascular conditions would exclude a participant?

How long must a participant wait after completing another clinical trial before enrolling in this study?

Which of the following counts is required for inclusion in the study?

Study Overview

Conducted as a randomized, double-blind, active-controlled phase 3 study on the drug ABP 959.
Target condition: Paroxysmal Nocturnal Hemoglobinuria (PNH).
Comparison between ABP 959 and Eculizumab in adult subjects.

Study Details

Official title includes evaluation of efficacy and safety.
Study Identifier: 20150168.
Enrollment involved 42 participants.
Started on January 22, 2019; primary and completion dates were both July 12, 2022.
Interventional study focusing on drug treatments.

Study Locations

24 study locations across multiple countries including the United States, Czechia, Finland, France, Ireland, Italy, Netherlands, Norway, Portugal, Slovenia, Spain, Sweden, Turkey, and the United Kingdom.
Notable sites:
- Atlanta, Georgia, USA: Children's Healthcare of Atlanta at Egleston.
- Brno, Czechia: Fakultní Nemocnice Brno.
- Dublin, Ireland: Saint James's Hospital.
- London, England: King's College Hospital NHS Foundation Trust.

Participant Eligibility

Inclusion Criteria:
- Adults aged 18 and above.
- Historical diagnosis of PNH.
- Must have been on 900 mg of Eculizumab for ≥ 6 months.
- Hemoglobin levels must be ≥ 9.0 g/dL for at least 6 weeks prior to randomization.
- Lactate dehydrogenase levels < 1.5 times the upper limit of normal at screening.
- Platelet count must be ≥ 50 x 10^9/L and absolute neutrophil count (ANC) ≥ 0.5 x 10^9/L.
- Vaccination against Neisseria meningitidis required.
- Participants must provide signed informed consent.
Exclusion Criteria:
- Known or suspected hereditary complement deficiencies.
- Significant cardiovascular diseases or conditions in the last 6 months.
- Evidence of acute thrombosis.
- Known HIV positivity.
- Pregnant or breastfeeding women.
- Recent involvement in other investigational studies within the last 30 days.

Additional Information

NIH National Library of Medicine provided resource links related to PNH and relevant drug information.
The study aims to enhance understanding and treatment options for patients with PNH.

This quiz covers a randomized, double-blind, active-controlled phase 3 study evaluating the efficacy and safety of ABP 959 compared to Eculizumab in treating paroxysmal nocturnal hemoglobinuria. Participants' responses and outcomes are analyzed to determine the effectiveness of the treatments. Test your knowledge on the study design, interventions, and conditions involved.