Personalized Prediction of Tolerance and Immunogenicity in Hemophilia

ClinicalTrials.gov ID: NCT01626105

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Official title

Study of Severe Hemophilia A Patients Who Have Only Received a Single Recombinant FVIII Therapeutic for the Purpose of Identifying the Pharmacogenetic Determinants of Tolerance and Immunogenicity

Brief summary

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

This study is designed to accurately identify the pharmacogenetic determinants of risk of Factor VIII (FVIII) inhibitor development by focusing on only a select group of Hemophilia A (HA) patients who have: (i) received a recombinant FVIII therapeutic product containing the same primary amino acid sequence since their original diagnosis; (ii) verifiable FVIII infusion histories; and (iii) been tested regularly for FVIII inhibitor development.

Study identification

NCT ID: NCT01626105
Recruitment status: Not listed
Study type: Observational
Phase: Not listed
Lead sponsor: Victor J Marder, M.D.; Other
Enrollment: 55 participants

Conditions and interventions

Conditions

Hemophilia A

Interventions

Not listed

Eligibility (public fields only)

Age range: 2 Years and older
Sex: Male
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: Jun 2012 (Type not available)
Primary completion: Apr 2013 (Estimated)
Completion: Jun 2014 (Estimated)
Last update posted: Jul 26, 2012

2012 – 2014

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Children's Hospital of Michigan	Detroit	Michigan	48201-2196	—

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

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01626105, 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 26, 2012 · Synced Nov 12, 2026