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Long-term Safety and Tolerability of HRS-5965 in Patients With Paroxysmal Nocturnal Hemoglobinuria

NCT ID: NCT06238544

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-06

Study Completion Date

2027-12-31

Brief Summary

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This is a multicenter, single-arm, open-label study. Patients with Paroxysmal Nocturnal Hemoglobinuria who had previously received and completed the HRS-5965 study well included. All eligible subjects received HRS-5965 tablets or capsules until the end of treatment in this study.

Detailed Description

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Conditions

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Paroxysmal Nocturnal Hemoglobinuria

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HRS-5965 Group

Group Type EXPERIMENTAL

HRS-5965 tablets

Intervention Type DRUG

HRS-5965 tablets until the end of study treatment

HRS-5965 Capsules

Intervention Type DRUG

HRS-5965 capsules.

Interventions

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HRS-5965 tablets

HRS-5965 tablets until the end of study treatment

Intervention Type DRUG

HRS-5965 Capsules

HRS-5965 capsules.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1\. Patients who have previously received and completed HRS-5965 study treatment, and are judged by the investigator to have treatment benefit and may benefit from continued treatment of HRS-5965 and patients in the control group of who received eculizumab treatment.

Exclusion Criteria

1. Known or suspected hereditary or acquired complement deficiency;
2. History of infection with capsular bacteria (e.g., meningococcus, pneumococcus, etc.)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chengdu Suncadia Medicine Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status

The Blood Disease Hospital of the Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

Site Status

Countries

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China

Other Identifiers

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HRS-5965-203

Identifier Type: -

Identifier Source: org_study_id