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Sponsored by: |
HemaQuest Pharmaceuticals Inc. |
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Information provided by: | HemaQuest Pharmaceuticals Inc. |
ClinicalTrials.gov Identifier: | NCT00790127 |
The purpose of this study is to evaluate the safety and tolerability of HQK-1001 administered daily for 8 weeks in subjects with beta thalassemia intermedia
Condition | Intervention | Phase |
---|---|---|
Beta Thalassemia |
Drug: HQK-1001 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi-National, Double Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HQK-1001 in Subjects With Beta Thalassemia Intermedia, Including Hemoglobin E Beta Thalassemia |
Estimated Enrollment: | 56 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Placebo: Placebo Comparator
Placebo
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Drug: Placebo
Matching placebo capsules administered once a day, orally, for 56 days
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HQK-1001: Experimental
HQK-1001
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Drug: HQK-1001
HQK-1001 capsules (10, 20, 30 or 40 mg) administered once a day, orally, for 56 days
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Ages Eligible for Study: | 12 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sally Case | 617-750-5943 | scase@hemaquest.com |
United States, California | |
Children's Hospital & Research Center | |
Oakland, California, United States, 94609 | |
Lebanon | |
Chronic Care Center | |
Beirut, Lebanon | |
Thailand, Bangkoknoin District | |
Siriraj Hospital | |
Bangkok, Bangkoknoin District, Thailand, 10700 |
Responsible Party: | HemaQuest Pharmaceuticals Inc. ( Susan Perrine, M.D. Chief Scientific Officer, VP Clinical Affairs ) |
Study ID Numbers: | HQP-2008-003b |
Study First Received: | November 11, 2008 |
Last Updated: | November 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00790127 |
Health Authority: | United States: Food and Drug Administration; Thailand: Food and Drug Administration; Thailand: Ethical Committee; Lebanon: Ministry of Public Health; Lebanon: Institutional Review Board |
Anemia, Hemolytic, Congenital Thalassemia minor Genetic Diseases, Inborn Hematologic Diseases Hemoglobinopathies Beta-Thalassemia |
Beta-thalassemia Anemia Anemia, Hemolytic Hemoglobinopathy Thalassemia |