Health TrialsbyHealthPanel

A Long-term Efficacy and Safety of NTQ5082 Capsules

ConditionParoxysmal Nocturnal Hemoglobinuria
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNanjing Chia-tai Tianqing Pharmaceutical

About this trial

NTQ5082 capsules are a small molecule CFB inhibitor. This study is a multicenter, open-label study evaluating the long-term efficacy and safety of NTQ5082 capsules in the treatment of patients with paroxysmal nocturnal hemoglobinuria

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1) Age ≥ 18 years, regardless of gender. 2) Subjects who have previously received and completed NTQ5082 study treatment and, as determined by the investigator, have benefited from treatment and are likely to benefit from continued NTQ5082 treatment, or subjects in the control group receiving eculizumab.

Disqualifiers

1) Previous history of bone marrow/hematopoietic stem cell or solid organ transplant (e.g., heart, lung, kidney, liver).

Trial design

Design model

Single group

Treatments tested in this trial

  • NTQ5082 capsules 200 mg

    Drug

    NTQ5082 capsules 200 mg

Treatment groups

78 Participants
are divided into 1 treatment group
Group A: NTQ5082Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence and severity of adverse events

Time frame
96 Weeks

Secondary outcomes

1

the proportion of subjects with hemoglobin (HB) levels ≥ 120 g/L without red blood cell (RBC) transfusion

Time frame
96 weeks
2

the change in hemoglobin level compared to before NTQ5082 capsule treatment without red blood cell transfusion

Time frame
96 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nanjing Chia-tai Tianqing Pharmaceutical

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: