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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: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Health Services Research |
| 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 |
|---|---|
| Experimental: Open Label |
Drug: Etanercept
All qualified subjects receive 24 weekly subcutaneous injections of Etanercept.
Other Name: Enbrel
|
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: | Stella M. Davies, MB BS, PhD, MRCP, Cincinnati Children's Hospital Medical Center |
| ClinicalTrials.gov Identifier: | NCT00965666 History of Changes |
| Other Study ID Numbers: | 05-07-24 |
| Study First Received: | August 24, 2009 |
| Last Updated: | August 24, 2009 |
| 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 |
|
Anemia Fanconi Anemia Fanconi Syndrome Hematologic Diseases Anemia, Hypoplastic, Congenital Anemia, Aplastic Bone Marrow Diseases Genetic Diseases, Inborn DNA Repair-Deficiency Disorders Metabolic Diseases Kidney Diseases Urologic Diseases Renal Tubular Transport, Inborn Errors Metabolism, Inborn Errors TNFR-Fc fusion protein |
Antirheumatic Agents Immunoglobulin G Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Gastrointestinal Agents Immunologic Factors Immunosuppressive Agents Central Nervous System Agents |