Health TrialsbyHealthPanel

Efficacy and Safety Evaluation Study of SCT800 in Previously Untreated Hemophilia A Patients.

ConditionHaemophilia A
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
AgeUp to 6
SponsorSinocelltech Ltd.

About this trial

This is an Open Label, Uncontrolled Study to Evaluate the the Safety and Efficacy of SCT800 for Prophylaxis Treatment in Severe Previously Untreated Hemophilia Patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male subjects with severe hemophilia A (FVIII:C < 1% in central laboratory tests)

previously untreated with pdFVIII/rFVIII, including marketed SCT800 (those who have previously used ≤5EDs of blood products such as cryoprecipitate or fresh frozen plasma are acceptable).

FVIII inhibitor negative

informed consent.

Disqualifiers

Known allergy to recombinant coagulation factor VIII concentrate or any excipient; known allergy to bovine, rodent or hamster bovine;

subjects with a history or family history of FVIII inhibitor formation;

Clinical liver function test (ALT、AST) ≥ 5 ULN or clinical kidney function test (BUN，Cr) ≥2 ULN;

Patients with other coagulation dysfunction diseases in addition to hemophilia A.

Trial design

Design model

Single group

Treatments tested in this trial

  • SCT800 prophylaxis and treatment for bleeding events

    Drug

    For prophylaxis, 15-50 IU/kg SCT800 is intravenously. For control of bleeding events(BE), 10-20 IU/kg for mild BE, 15 -30IU/kg for moderate BE, 30-50IU/kg for severe BE.

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: SCT800 prophylaxis and control of bleeding eventsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of FVIII inhibitor

The percentage of FVIII inhibitor measured by Nijmegen-Bethesda

Time frame
up to 50-100 Exposure Days

Secondary outcomes

1

The percentage of adverse events

Time frame
up to 50-100 exposure days
2

annualized bleeding rate

Annualized Bleeding Rate（ABR） can be calculated using the following formula: Number of bleeding events in efficacy evaluation period/(number of days in treatment period/365.25)

Time frame
up to 50-100 exposure days
3

annualized joint bleeding rate

Annualized joint bleeding rate（AJBR） can be calculated using the following formula: Number of joint bleeding events during efficacy evaluation period/(number of days in treatment period/365.25).

Time frame
up to 50-100 exposure days
4

consumption of SCT800

consumption of SCT800 per month and per year

Time frame
up to 50-100 exposure days

Other outcomes

Sponsors and contacts

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

Sinocelltech Ltd.

Lead sponsor

Source ClinicalTrials.gov
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