NCT03588026

Treating Paroxysmal Nocturnal Haemoglobinuria Patients With rVA576

Investigational Product ; Coversin. Phase III Safety and Efficacy in Three-Part, Two-Arm, Randomised Open Label Evaluation in Patients With Paroxysmal Nocturnal Haemoglobinuria (PNH)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: AKARI Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

rVA576 for patients with Paroxysmal Nocturnal Hemoglobinuria (PNH).

Detailed description

rVA576, a small protein complement C5 inhibitor which prevents the cleavage of C5 by C5 convertase into C5a and C5b, will be used in an open label, non-comparative clinical trial in patients with PNH. Patients will be treated with rVA576 by daily subcutaneous injection in order to determine the safety and efficacy of the drug in these circumstances. If satisfactory control of the PNH is achieved, and at the discretion of the Principal Investigator (PI), patients will have the option of remaining on rVA576 and being entered into the long term follow-up study.

Conditions

• Paroxysmal Nocturnal Hemoglobinuria (PNH)

Interventions

Type	Name	Description
DRUG	rVA576	6 months of treatment, rVA576 plus SOC. Followed by a further 3 months of rVA576 plus SOC. In total, 9 months on rVA576 plus SOC.
OTHER	Standard of care (SOC)	6 months on SOC followed by 3 months of treatment with rVA576 plus SOC. In total, 3 months on rVA576 plus SOC.

Timeline

• Start date: 2018-06-07
• Primary completion: 2020-09-03
• Completion: 2020-09-03
• First posted: 2018-07-17
• Last updated: 2025-04-09

Locations

3 sites across 3 countries: Kazakhstan, Lithuania, Sri Lanka