MedTrace Logo

China ADVATE PTP Study

NCT02170402 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2021-05-03

No results posted yet for this study

Summary

The purpose of this study is to assess efficacy, safety and pharmacokinetics of ADVATE in the treatment and prevention of bleeding episodes (BEs)

Conditions

Interventions

BIOLOGICAL

Octocog alfa (recombinant human coagulation factor VIII)

* Part 1: Pharmacokinetic (PK) analysis - Subset of 24 participants * Part 2: On-demand treatment regimen * Part 3: Prophylaxis treatment regimen

Sponsors & Collaborators

  • Baxalta now part of Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-26
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02170402 on ClinicalTrials.gov