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| Sponsor: | Children's Hospital Medical Center, Cincinnati |
|---|---|
| Collaborator: |
Amgen |
| Information provided by: | Children's Hospital Medical Center, Cincinnati |
| ClinicalTrials.gov Identifier: | NCT00965666 |
Purpose
The purpose of this research study is to evaluate the safety of the drug Etanercept (Enbrel) and to determine if this drug can help in the treatment of early bone marrow failure in patients with Fanconi anemia.
| Condition | Intervention |
|---|---|
|
Fanconi Anemia |
Drug: Etanercept |
| Study Type: | Interventional |
| Study Design: | Health Services Research, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Etanercept (Enbrel) in Children With Fanconi Anemia and Early Bone Marrow Failure: A Pilot Study |
| Estimated Enrollment: | 10 |
| Study Start Date: | October 2005 |
| Estimated Study Completion Date: | October 2010 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Open Label: Experimental |
Drug: Etanercept
All qualified subjects receive 24 weekly subcutaneous injections of Etanercept.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 4 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Robin Mueller, RN | 1 800 344 2462 ext 3218 | robin.mueller@cchmc.org |
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | Recruiting |
| Cincinnati, Ohio, United States, 45229-3039 | |
| Principal Investigator: Stella M. Davies, MBBSPhD MRCP | |
| Principal Investigator: | Stella M. Davies, MBBSPhd MRCP | Children's Hospital Medical Center, Cincinnati |
More Information
| Responsible Party: | Cincinnati Children's Hospital Medical Center ( Stella M. Davies, MB BS, PhD, MRCP ) |
| Study ID Numbers: | 05-07-24 |
| Study First Received: | August 24, 2009 |
| Last Updated: | August 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00965666 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Fanconi Anemia Hemic and Lymphatic Diseases Anti-Rheumatic Agents Anemia, Hypoplastic, Congenital |
DNA Repair-Deficiency Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
|
Anti-Inflammatory Agents Metabolic Diseases Immunologic Factors Hematologic Diseases Fanconi Anemia Physiological Effects of Drugs DNA Repair-Deficiency Disorders Gastrointestinal Agents Anemia TNFR-Fc fusion protein Immunosuppressive Agents Pharmacologic Actions |
Anemia, Hypoplastic, Congenital Genetic Diseases, Inborn Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Anemia, Aplastic Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Bone Marrow Diseases Central Nervous System Agents |