Extension Study of RA101495 in Paroxysmal Nocturnal Hemoglobinuria (PNH)

Phase 1

• Conditions: Paroxysmal Nocturnal Hemoglobinuria (PNH); MedDRA version: 21.1Level: LLTClassification code 10055629Term: Paroxysmal nocturnal hemoglobinuriaSystem Organ Class: 100000004857; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2016-003523-34-FI
• Lead Sponsor: Ra Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-27
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Male or female > 18 years having completed a qualifying RA101495 clinical study and met predefined criteria for extended treatment with RA101495
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

1. Platelet count <30,000/µL or absolute neutrophil count (ANC) <500 cells/µL at Screening
2. Calculated glomerular filtration rate of <30 mL/min/1.73m2 based on modification of diet in renal disease (MDRD) equation at Screening
3. History of meningococcal disease
4. Current systemic infection or suspicion of active bacterial infection
5. Pregnant, planning to become pregnant, or nursing female subjects

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified