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NCT01652027 · ClinicalTrials.gov registry record
Hemophilia Inhibitor Previously Untreated Patient Study
A clinical trial, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- 25
- Enrollment target
NCT01652027 is a clinical trial that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 25 participants.
The verdict
NCT01652027 has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- 25 participants
- Enrollment target
Study Summary
Hemophilia A is a congenital bleeding disorder caused by deficiency of factor VIII (FVIII) and is treated by replacement therapy with FVIII concentrate. Approximately 30% of people with severe hemophilia A develop neutralizing antibodies, called FVIII inhibitors, which interfere with the function of FVIII concentrates. The reason that some, but not all, people with severe hemophilia A develop inhibitors is incompletely understood. Understanding individual and environmental risk factors is important to be able to prevent and possibly treat inhibitors. This study will look at individual and treatment characteristics in babies with severe hemophilia A who have not yet received treatment with FVIII (called Previously Untreated Patients, or PUPS). Subjects in the study will be asked to provide diaries of treatments, medications, and illnesses. Treatment will be directed by the subjects' physician, but all subjects will receive Advate, a third-generation recombinant FVIII product. Subjects will have blood drawn for laboratory tests, which include studies of the immune system and genetic studies of the FVIII mutation, before and 7-9 days after the first treatment with FVIII, and 5 days (+/-2 days) after the 5th, 10th, 20th, 30th, 40th, and 50th days of treatment with FVIII (exposure days). The duration of the study will be first 50 treatments or 3 years, whichever comes first.
Interventions
- DRUG FVIII concentrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2011-07 |
| Est. Completion | 2020-03 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01652027
The ClinicalTrials.gov registry entry for NCT01652027 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center, Houston, which has 732 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which FVIII concentrate is the first listed.
NCT01652027 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01652027 about?
NCT01652027 is a clinical study titled "Hemophilia Inhibitor Previously Untreated Patient Study". Hemophilia A is a congenital bleeding disorder caused by deficiency of factor VIII (FVIII) and is treated by replacement therapy with FVIII concentrate. Approximately 30% of people with severe hemophilia A develop neutralizing antibodies, called FVIII inhibitors, which interfere with the function of...
What is the current status of trial NCT01652027?
This trial is currently completed. The enrollment target is 25 participants. The study started on 2011-07. Estimated completion is 2020-03.
What interventions are being tested in trial NCT01652027?
The interventions under investigation include: FVIII concentrate (DRUG).
Who is sponsoring clinical trial NCT01652027?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
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