Safety, Efficacy and Pharmacokinetics of GreenGene™ F to Previously Treated Patients With Severe Hemophilia A

ClinicalTrials.gov ID: NCT01619046

Public ClinicalTrials.gov record NCT01619046. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

Determination of Safety, Efficacy and Pharmacokinetics of GreenGene™ F in Previously Treated Patients 12 Years of Age or Older Diagnosed With Severe Hemophilia A

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to assess the safety, efficacy and pharmacokinetics of GreenGene™ F in subjects with severe hemophilia A previously treated (\> 150 exposure days) with a Factor VIII concentrate and without presence or history of inhibitors to FVIII (Factor VIII).

Study identification

NCT ID: NCT01619046
Recruitment status: Not listed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Green Cross Corporation; Industry
Enrollment: 124 participants

Conditions and interventions

Conditions

Hemophilia A

Interventions

GreenGene™ F and an approved recombinant Factor VIII product Biological
GreenGene™ F Biological

Biological

Eligibility (public fields only)

Age range: 12 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Feb 28, 2013
Primary completion: Jun 30, 2015
Completion: Aug 31, 2015
Last update posted: Jul 2, 2014

2013 – 2015

United States locations

U.S. sites: 10
U.S. states: 9
U.S. cities: 10

Facility	City	State	ZIP	Site status
Arkansas Children's Hospital	Little Rock	Arkansas	72202	Recruiting
Los Angeles Orthopaedic Hospital - Hemophilia Treatment Center	Los Angeles	California	90007	Recruiting
Harbor - UCLA Pediatrics	Torrance	California	90509	Recruiting
University of Miami - Comprehensive Hemophilia Center	Miami	Florida	33101	Recruiting
St. Luke's Boise Medical Center	Boise	Idaho	83712	Recruiting
Rush University Medical Center	Chicago	Illinois	60612	Recruiting
Michigan State University Center for Bleeding Disorders & Clotting Disorders	East Lansing	Michigan	48823	Recruiting
Children's Mercy Hospital - Kansas City Regional Hemophilia Center	Kansas City	Missouri	64108	Recruiting
Long Island Jewish Medical Center - Hemophilia Treatment Center	New Hyde Park	New York	11040	Recruiting
Oregon Health and Science University	Portland	Oregon	97239	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 24 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01619046, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jul 2, 2014 · Synced Sep 13, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01619046 live on ClinicalTrials.gov.

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