For Healthcare Professionals

Pharmacokinetic Study of SCT800 in Previously Treated Patients With Hemophilia A

clipboard-pencil

About the study

Participants will be assigned to A or B groups with a scale of 1:1 based on a prospectively randomized treatment-sequence assignment, i.e. infuse SCT800 followed by Xyntha (group A), or the alternate sequence (group B). All participants who completed the SCT800HA1 study will enter the efficacy and safety study (Protocol No.: SCT800HA3).
user-3

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. 12 to 65 years old;
  2. The activity of the coagulation factor VIII (FVIII:C) ≤2%, and was previously treated with FVIII concentrate(s) for a minimum of 50 exposure days (EDs) prior to study entry
  3. Non-bleeding state (No clinical manifestations of active hemorrhage);
  4. Negative assays for FVIII inhibitors (<0.6 BU/mL);
  5. The platelet count is normal;
  6. Normal prothrombin time or INR ≤1.5;
  7. Given informed consent

EXCLUSION CRITERIA

  1. Hypersensitivity to recombinant coagulation factor VIII concentrate or any of the excipients ;allergic to heterologous proteins (e.g. murine, bovine or hamster origin);
  2. Family history or history of FVIII inhibitors (≥0.6 Bethesda Units [BU] mL-1);
  3. Received an infusion of any FVIII for on-demand therapy or prophylaxis within 4 days prior to study entry (including rFVIII, plasma-derived factor VIII [pdFVIII], cryoprecipitate and whole blood);
  4. Significant hepatic or renal impairment (ALT and AST ≥2×ULN; BUN and Cr≥2×ULN);
  5. HIV seropositive;
  6. Abnormal hemostasis from causes other than hemophilia A;
  7. Patients with severe heart disease, including myocardial infarction, heart failure (III or higher level);
  8. Patients who received any anticoagulant or antiplatelet therapy within one week (including NSAIDs) or need to receive an anticoagulant or antiplatelet therapy during the period of clinical trials;
  9. Alcoholism, drug abuse, mental disorders and mental retardation;
  10. Elective surgery planned during the process of study;
  11. Patients who previously participated in the other clinical trials prior to study entry;
  12. The patient or parent/legal guardian is unable or unwilling to sign an informed consent form or to comply with the requirements of clinical protocol;
  13. Other conditions confirmed by the researchers, resulting in that patients are unable to benefit from clinical observation;
pin location

Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Hemophilia A

Age

12+

Phase

Phase 1

Participants needed

16

Est. Completion Date

Jul 2017

Treatment type

Interventional


Sponsor

Sinocelltech Ltd.

ClinicalTrials.gov identifier

NCT02888223

Study number

SCT800HA1

Understanding Clinical Trials


Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?
Vector

Interested?

Sign up to save your favorites, 
receive newsletters, resources, and alerts 
about clinical trials related to your conditions of interest.